DAILY RELEVANT REGULATORY NEWS
Training presentations on Active Substance Master File (ASMF) work sharing procedureNew read more >
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Pharmacopoeial discussion group achievementsThe face-to-face meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP)] was hosted by the EDQM in Strasbourg, France, on 2-3 October 2018. WHO participated as Observer.
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Questions and answers related to the United Kingdom's withdrawal from the European Union with regard to the biocides sectorUpdate Version read more >
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EMA Blocks Aurobindo Pharma From Supplying IrbesartanEU authorities have increased scrutiny of Chinese API maker Zhejiang Huahai, the valsartan manufacturer linked to the original contamination of APIs used in blood pressure drugs.
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MIT Researchers Develop New Way to Crowd-Source Drug DataResearchers at MIT say they’ve developed a way for drug sponsors and researchers to share information without compromising private patient details or intellectual property.
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EU guidance for new Medical Device Regulation (MDR)With the coming into force of the Medical Device Regulation (MDR) in 2020, the guidelines 93/42/EEC and 90/385/EEC, which have regulated the field of medical devices so far, will become invalid. Two EU documents define what is going to change and how the changes need to be implemented.
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Diethanolamine - Suspension of marketing authorizations for veterinary medicines containing diethanolamine for food-producing animalsThe DGAV points out that the sale of any veterinary medicine containing Diethanolamine is prohibited. This prohibition covers not only the supply of such medicines by MA holders and Wholesale Distributors of Medicines and/or Veterinary Medicines, but also by pharmacies and Retail Stores of Veterinary Medicines
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EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision.read more >
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Fluoroquinolones and quinolones – new restrictions on useThe European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of fluoroquinolone and quinolone antibiotics.
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FDA Breaks Record for Most Generic ApprovalsThe FDA broke its generic drug approval record yet again, FDA Commissioner Scott Gottlieb said Thursday, reporting that fiscal 2018 has seen the most approvals and tentative approvals.
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Version 11 of EU Q&As on Safety Features: Specific Questions on StickersThe European Commission released version 11 of the questions and answers catalogue on safety features in September 2018. It also addresses the placing of safety features by means of stickers in detail. Get more information about safety features in the revised Q&A document of the EU.
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Ph. Eur. Supplement 9.7: CEP holders are invited to update their applicationsSupplement 9.7 of the Ph. Eur is now available.
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FDA: Guidance on Quality ChewablesIn vitro disintegration tests should be conducted using established disintegration equipment and methods, the FDA says.
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Pharmacovigilance: Be prepared for "Hard Brexit"The UK Government has released some information regarding the consequences of the Brexit on pharmacovigilance and the establishment of the Qualified Person for Pharmacovigilance (QPPV).
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European Pharmacopoeia: New Chapter on Visual Inspection for Visible ParticlesThe European Pharmacopoeia has published a new chapter on testing of parenterals for visible, particulate matter in Pharmeuropa 30.4.
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Perguntas e respostas sobre o sistema dos dispositivos de segurançaO sistema dos dispositivos de segurança surgiu com a diretiva 2011/62/EU do Parlamento Europeu e do Conselho, de 8 de junho de 2011 e encontra-se regulado pelo Regulamento Delegado (UE) 2016/161, da Comissão de 2 de outubro de 2015, de aplicação direta na ordem jurídica nacional, e pelo Estatuto do medicamento, na sua redação atual.
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Stock break of the medicine Sinemet - alternatives (postponement)To ensure that the treatment is available for all patients, it is essential that doctors, pharmacies and distributors manage the available stocks carefully. Patients are also encouraged to pick up the medication at the pharmacies only when needed. It should be noted that any change in treatment should be previously evaluated by the doctor.
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Sponsor Oversight of Clinical Trials - How to improve compliance?There is no "one size fits all" for the management of clinical trials. However, there is a clear requirement according to GCP that the sponsor retains all responsibility for the conduct and reporting of clinical trials.
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New Q&As on Chapter 3 of the EU-GDP Practice Guide (Premises and Equipment)The European GDP Association has published new Question & Answers on Chapter 3 of the EU-GDP Guide (Premises and Equipment).
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OMCLs release three methods for determination of NDMA in sartansSince early July 2018 Official Medicines Control Laboratories (OMCLs) of the General European OMCL Network (GEON) have been involved in investigations and actions to address the issues related to the detection of N-nitrosodimethylamine (NDMA) in valsartan. The Network has meanwhile developed methods for the specific testing of nitrosamines in sartans on the basis different analytical principles.
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Portugal to also benefit from EU-US mutual recognition agreement for inspectionsread more >
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CMDh Clarifications on the Implementation of the Falsified Medicines DirectiveIn April 2018, the CMDh published a document to clarify questions which arose from the original Q&A document dated March 2017 on the implementation of the Falsified Medicines Directive. Read more about the document "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".
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FDA Grants First Approvals Via the Competitive Generic Therapy PathwayThe FDA approved drug products under the Competitive Generic Therapy (CGT) designation for the first time, granting approval to several strengths of Apotex’s potassium chloride oral solution.
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FDA Releases Product-Specific Guidances to Foster Generic CompetitionOne of the most effective ways for the FDA to increase patient access to high quality generics is to offer guidance that promotes the development of cost-saving generics, especially for complex drugs that are difficult to copy, he said.
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FDA awards five grants to advance the development of pediatric medical devicesThe U.S. Food and Drug Administration announced today that it has awarded five grants totaling up to $6 million per year over the next five years to Pediatric Device Consortia (PDC) across the country that will provide advice and support services to innovators of children's medical devices.
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New Questions and Answers on Safety Features - EU Q&As Version 10 published!The safety features required for the implementation of the Anti-Counterfeit Directive will have to be implemented by the 9th February 2019. The European Commission released version 10 of the questions and answers catalogue on safety features in July 2018. Get more details about the revised Q&A document of the EU on safety features.
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New support pages for industry on obligations for hazardous mixturesThe Poison Centres website has been revamped with new support pages providing stepwise help for industry on how to prepare and submit information on hazardous mixtures.
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Dossier requirements for referral, active substance master files (ASMF) and nationally authorised products (NAPs) submissions (PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical deviceUpdate read more >
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Revised Guideline on requirements for revision/renewal of CEPsThe revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs’ (PA/PH/CEP (04) 2 7R) will enter into force in January 2019.
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Sanofi’s Treatment for Blood-Clotting Disorder Approved in EuropeThe authorization marks Sanofi’s first approval for a nanobody-based medicine
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FDA Issues Guidance on Controlling Elemental Impurities in DrugsThe FDA finalized its recommendations on how drug sponsors submitting applications should control elemental impurities in their drug products.
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Pre-notification check for type IA variations: ensuring the quality of veterinary type IA variation submissionsUpdate read more >
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What information is included in a CEP?The "Certificate of suitability to the Monographs of the European Pharmacopoeia" (CEP) contains information on an active pharmaceutical substance with regard to the European Pharmacopoeia. It is an important document of the authorisation application. Read more about what information is relevant for a CEP and what do CEP holders and authorisation applicants have to consider.
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FDA Issues Draft Guidance on Export Certificates for DeviceIn cases where the denial is specifically because of a facility’s noncompliance with GMPs, the agency will provide a “substantive summary” of the failures identified.
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FDA Suggests New Flexibility for Blinding Cancer TrialsCancer patients in clinical trials should be told whether they’ve been given placebos or experimental drugs if their tumors reappear or get worse—and patients and researchers should be told if sponsors are worried experimental drugs may be triggering bad reactions, the FDA says in new draft guidance released Thursday.
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Keeping medicines safe Keeping medicines safeHow EMA monitors medicines once they are on the market
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EMA publishes list of contact details for pharmacovigilance enquiriesThe EMA published information extracted from the Article 57 database (xEVMPD) in the form of an Excel document. The file contains a complete list of all medicines authorized in the EEA with marketing authorization holders' dedicated contact details for pharmacovigilance enquiries.
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Update on medicines containing valsartan from Zhejiang TianyuCompany no longer authorised to manufacture valsartan active substance for EU medicines due to presence of NDMA.
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Launch of the new EudraVigilance system: questions and answers from stakeholdersUpdate read more >
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FDA approves first generic version of EpiPenThe U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds.
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New WHO guideline on medical devices and IVDsOn 76 pages spread over five chapters, the WHO has published a finalised regulatory framework for medical devices, including In-vitro-Diagnostics (IVDs), with the title "WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices".
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Pair of Anti-Malaria Drugs Win ApprovalThe sponsors will conduct post-marketing studies to make sure their drugs are safe and effective for children, elders and the obese.
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FDA approves first-of-its kind targeted RNA-based therapy to treat a rare diseaseThe U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients.
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FDA approves treatment for two rare types of non-Hodgkin lymphomaThe U.S. Food and Drug Administration today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.
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European Commission publishes revised Version of EU GMP Guideline Annex 2As consequence of the adopted new regulations of GMP for ATMPs, the European Commission published a revised version of the Annex 2 "Manufacture of Biological active substances and Medicinal Products for Human Use".
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Early access to medicines scheme: expired scientific opinionsMedicines that were granted a positive opinion under the early access to medicines scheme (EAMS) which has now expired.
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Brexit preparedness: EMA to further temporarily scale back and suspend activitiesThe European Medicines Agency (EMA) will launch the next phase of its business continuity plan on 1 October 2018 at the latest. This will allow the Agency to safeguard core activities related to the evaluation and supervision of medicines, while it has to intensify its preparations for the physical move to Amsterdam in March 2019 and cope with significant staff loss.
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Cooperation of international authorities for inspecting API manufacturersThe aim of the International API Inspection Programme is the cooperation of authorities in monitoring and controlling API manufacturers. Read here, by which measures an optimised bundling and efficiency enhancement of the regulatory supervision of API facilities via GMP inspections are to be reached.
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Collecting Patient Experience Data for Product DevelopmentThe FDA recently released a guidance on patient experience data from patients, caregivers, clinicians and others for product development and regulatory decision-making.
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EudraVigilance: how to registerPharmaceutical companies holding or applying for a marketing authorisation in the European Economic Area (EEA), sponsors of clinical trials and national competent authorities in the EEA need to register with EudraVigilance for the electronic data interchange of pharmacovigilance information. The registration process is a prerequisite for electronic reporting.
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IT systems unavailable from 27 to 30 July 2018EMA website and online applications will be temporarily unavailable
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United Kingdom wants to remain in the EMAIt's official: the United Kingdom wants to remain in the EMA. This can be gathered from a recent statement by the government.
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Roche’s Tecentriq Gets Breakthrough Therapy StatusThe FDA granted a breakthrough therapy designation to Roche’s Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) to treat hepatocellular carcinoma.
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FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutationThe U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion diagnostic used to detect specific mutations in the IDH1 gene in patients with AML.
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EU and Japan reinforce their collaboration on inspections of medicine manufacturersUpdate of 2004 mutual recognition agreement extends scope to sterile products, active pharmaceutical ingredients and biologicals including vacines.
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CEP document revised: “Implementation of ICH Q3D in the Certification Procedure”The EDQM document “Implementation of ICH Q3D in the Certification Procedure” has been revised based on experience gained by EDQM since the initial implementation of the policy. Its implementation date is the 1st September 2018.
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EMA’s proactive publication of clinical data a successFirst report on unprecedented transparency policy shows high user satisfaction.
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FDA approves the first drug with an indication for treatment of smallpoxThe U.S. Food and Drug Administration today approved TPOXX
(tecovirimat), the first drug with an indication for treatment of smallpox.
Though the World Health Organization declared smallpox, a contagious and sometimes
fatal infectious disease, eradicated in 1980, there have been longstanding
concerns that smallpox could be used as a bioweapon.
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New versions of the 4 electronic Application Forms (eAF v. 1.23)This release includes further integration with OMS for organisation data in proposed and present part of Variation form and other NTA changes. This new version, 1.23 of the forms can be used as of today (13th July 2018) and will fully replace the version 1.22.0.1 after transitional period, on 15 October 2018. The version of the form should not be changed during an ongoing procedure.
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FDA Issues Advice on Limited Population Pathway for AntimicrobialsThe FDA released draft guidance for sponsors who want to use the agency’s limited population pathway for antibacterial and antifungal drugs.
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Ph.Eur. Supplement 9.6 available nowThe 9.6 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 January 2019.
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FDA Issues Draft Labeling Guidance on Indications and UsageThe FDA released draft guidance outlining the information sponsors should include on the Indications and Usage section of drug and biologics labeling.
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IMPs: EMA updates timeline for portal and databaseThe EMA has announced a new timeline for the application of the Clinical Trials Regulation due to the EMA`s move to Amsterdam because of the Brexit.
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ICH Q13 supports continuous manufacturingOn 22 June, it became official: the International Council for Harmonisation (ICH) announced in a press release that with the new Guideline ICH Q13, they would support the introduction of continuous manufacturing processes into the pharmaceutical industry.
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FDA Suggests Alternatives for Demonstrating CGMP Compliance for Combination ProductsThe FDA released a list of alternative suggestions for complying with CGMP requirements for drug combination products that covers stability testing, release for distribution, reserve samples and special testing requirements.
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First two CAR-T cell medicines recommended for approval in the European UnionThe European Medicines Agency (EMA) has recommended the first two marketing authorisations for chimeric antigen receptors (CAR) T-cells medicines in the European Union (EU). Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) are advanced therapies for blood cancer. They belong to a new generation of personalised cancer immunotherapies that are based on collecting and modifying patients’ own immune cells to treat their cancer.
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FDA: Oncology Radiopharmaceutical Labeling Must Include GenotoxicityLabeling for oncology radiopharmaceuticals must include information on the potential for genotoxicity and adverse reproductive toxicity, the FDA said in new draft guidance.
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ICH M9 reaches Step 2b of the ICH ProcessThe ICH M9 Biopharmaceutics Classification System-based Biowaivers reached Step 2b of the ICH Process in June 2018 and now enters the consultation period.
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Batch Release without a QP - Is this possible?Batch certification by a QP is one of the essential requirements in the EU GMPs. However one company in Spain has released products to the market without the QP - with reasonable consequences. read more >
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FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsyThe U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.
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Procedure for orphan-medicinal-product designation: Guidance for sponsors submitting an application via the current existing submission process until 19 Sept 2018read more >
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FDA approves automated insulin delivery and monitoring system for use in younger pediatric patientsThe U.S. Food and Drug Administration expanded the approval of the MiniMed 670G hybrid closed looped system, a diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the user, to include individuals aged 7 to 13 with type 1 diabetes. The FDA originally approved this device in September 2017 for use in patients 14 years of age and older with type 1 diabetes.
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Revision of PIC/S GMP Guide (PE 009-14)The revised Chapters 3, 5, & 8 of the PIC/S GMP Guide are based on the equivalent Chapters of the EU GMP Guide with some minor differences in terms of language. These Chapters of the PIC/S GMP Guide have now been aligned with principles of Quality Risk Management.
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Quality defects: EMA updates Defective Product Report TemplateThe European Medicines Agency (EMA) has updated their document for reporting quality defects in drug products.
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FDA Issues Questions and Answers on Implementing ICH S9 GuidanceCancer drug sponsors facing challenges in implementing the ICH S9 guidance on nonclinical evaluations of their drugs may find answers in a new ICH guidance released by the FDA.
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Time Is Running Out to Prepare for New EU MDR/IVDR: MedTech EuropeOne year after the EU finalized its new medical device and in vitro diagnostics regulations there has been little progress in helping industry transition to the new regulations, according to MedTech Europe.
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New PIC/S guidance on GMP inspection reliance based on draft by ICMRA with aim to maximise inspection resources for GMP compliance of overseas facilitiesPIC/S has adopted a new guidance on GMP inspection reliance (PI 048-1), which entered into force on 1 June 2018.
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Falsified Medicines Directive - securPharm status report for 2018There isn't much time left until the safety features required in the future will have to be implemented in order to comply with the Falsified Medicines Directive which will enter into force on 9 February, 2019. The German initiative securPharm has published a status report in this issue for the year 2018.
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Investigational Medicinal Products (IMP): Applicability of the GDP-GuidelinesA new draft EMA
Guideline requires that GDP-Guidelines for medicinal products should be taken
into consideration for IMP shipments.
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Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human UseJune 2018
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Monograph for Water, highly purified (1927) to be suppressed from the European PharmacopoeiaFollowing a decision taken by the European Pharmacopoeia (Ph. Eur.) Commission at its 160th session (March 2018), the monograph for Water, highly purified (HPW) will be suppressed on 1 April 2019 from the Ph. Eur. The monograph suppression is a consequence of the recent revision of the monograph for Water for injections (0169), which now allows for purification processes equivalent to distillation for producing water for injections (WFI), in addition to distillation. Hence, the HPW monograph is a duplication of the WFI monograph in terms of quality requirements and production methods, and as such became redundant.
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ICH Q3D(R1) revision reaches Step 2b of the ICH ProcessThe ICH Q3D(R1) Revision of the ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in May 2018 and now enters the consultation period.
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List of safety concerns per approved Risk Management Plan (RMP) of active substances per productUpdate read more >
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Unexpected deviation: what is the Role of the QP?The European Medicines Agency (EMA) has updated its Questions and Answers Section with an amendment to further clarify the role of the QP in the context of handling unexpected deviations.
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List of centrally authorised products requiring a notification of a change for update of annexesUpdate. read more >
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Development of antibiotics for children - towards a global approachThe European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States' Food and Drug Administration (FDA) are co-organising a workshop to discuss the development of antibiotics for children.
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Towards harmonisation in the classification of medicines across EuropeThe Committee of Ministers of the Council of Europe adopted a revised Resolution on the classification of medicines as regards their supply. It calls on the States Parties to the Convention on the Elaboration of a European Pharmacopoeia (Ph. Eur. Convention) to regularly provide information on their national classifications of medicines for inclusion in the Melclass database and follow the recommendations to classify active substances on the basis of the supply conditions of the medicines that contain them, as listed in the database. The new Resolution CM/Res(2018)1, which supersedes the previous Resolution ResAP(2007)1 from 2007, will continue to play a key role in providing 800 million citizens across Europe with safe access to medicines and to support national authorities in ensuring the appropriate and responsible use of medicines.
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New EDQM guideline "How to read a CEP"EDQM has elaborated the guideline “How to read a CEP” with the aim of describing in detail the information conveyed on the Certificates of suitability to the Monographs of the European Pharmacopoeia (CEP). This document is intended to give Industry and Competent Authorities clarification on the meaning of the statements laid down on the CEPs.
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FDA Issues Final Guidance on GMPs for APIsThe FDA released final guidance on its Q7 guidelines on good manufacturing practices for active pharmaceutical ingredients, using a question and answer format to clarify the document developed through the International Conference on Harmonization.
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Targeted stakeholder consultation on duplicate marketing authorisations for biological medicinal productsread more >
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FDA approves novel preventive treatment for migraineThe U.S. Food and Drug Administration approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.
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FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adultsThe U.S. FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days. Lucemyra is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD.
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EU Data Protection Regulation - Impact on Clinical Trials & PharmacovigilanceThe EU Data Protection Regulation will apply from May 25, 2018. It will introduce new data protection requirements in the EU as well as substantial fines for breaches of the data protection rules.
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Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human UseMay 2018 read more >
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FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patientsThe U.S. Food and Drug Administration approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the first FDA approval of a drug to treat MS in pediatric patients.
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FDA Clarifies the Term ‘Outsourcing Facility’ and Requirements for 503A CompoundersAs part of its increased focus on drug compounding, the FDA issued a final guidance clarifying the term “outsourcing facility” and detailing requirements for compounders operating under 503A that are next to an outsourcing facility.
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Roche Gains Priority Review for Tecentriq Combo Treatment in Cancer PatientsThe FDA granted priority review for Roche’s Tecentriq (atezolizumab) used in combination with Avastin (bevacizumab), paclitaxel and chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) patients.
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Questions and answers: Good manufacturing practiceThis page lists the European Medicines Agency's answers to frequently asked questions, as discussed and agreed by the Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group. The section on “EU GMP guide annexes: Supplementary requirements: Annex 16” was updated.
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Two years of PRIMEIn the two years since its launch, the PRIority Medicines scheme (PRIME) of the European Medicines Agency (EMA) has succeeded in driving innovation and improved the efficiency of the development process in therapeutic areas with the most pressing unmet medical needs. The goal is to support and optimise medicine development, so that patients whose diseases cannot be treated or who need better treatment options have access to new medicines that enable them to live healthier lives.
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Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCPread more >
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Evaluation of EMA fee system for the approval and monitoring of medicines:Public consultation launched today.
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EMA 2017 annual report publishedThe 2017 annual report published today provides an overview of the work of the European Medicines Agency (EMA) and highlights last year’s major achievements in protecting and promoting public and animal health in the European Union (EU).
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Quality Risk Management: What Inspectors are looking forICH Q9 is the major guideline providing principles and examples of tools for Quality Risk Management (QRM). But how do competent authorities look at these QRM systems in their GMP inspections?
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Q & A: Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities - updated 27/04/2018Questions and answers on implementation of risk-based prevention of
cross-contamination in production and ‘Guideline on setting health-based
exposure limits for use in risk identification in the manufacture of different
medicinal products in shared facilities’.
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Updated rules for clinical development of vaccinesEMA launches public
consultation on revised guideline on clinical evaluation of vaccines.
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The European Medicines Agency and the Netherlands agree on Seat AgreementThe European Medicines Agency (EMA) and the Netherlands have finalised the text of a Seat Agreement which describes how the Agency, its bodies and its employees will be treated by the Dutch Government once they start operating in the Netherlands. read more >
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Decree-Law no. 26/2018 – National Official Journal no. 80/2018, Series I of 2018-04-24Changes the legal status of the medicinal products for human use, transposing Directive (EU) 2017/1572.
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Public hearing about medicinal products containing quinolones and fluoroquinolonesIt is ongoing the safety review of the medicinal products containing quinolones and fluoroquinolones due to the occurrence of cases of severe and persistent adverse reactions which mostly affect the muscles, joints and the nervous system.
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FDA Issues Final Guidance on API Good Manufacturing Practices GuidelinesThe FDA released final guidance on its Q7 guidelines on good manufacturing practices for APIs, using a question and answer format to clarify the document developed through the International Conference on Harmonization.
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FDA Clears First Device to Use Artificial Intelligence to Identify Diabetic RetinopathyThe FDA cleared the first medical device to use artificial intelligence to measure eye disease diabetic retinopathy in diabetic adults. read more >
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Auditing Starting Materials - new APIC Guideline defines StandardsThe use of starting materials in the production process for active pharmaceutical ingredients marks the starting point for GMP. But how can the quality of starting materials be ensured?
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Resolution no. 481/2018 – National Official Journal no. 75/2018, Series II of 2018-04-17Change of the list of Previous Notification of transactions of medicinal products to outside the country.
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Meeting highlights from the PRAC: 9-12 April 2018The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of the risk of dosing errors with methotrexate medicines, used to treat cancers such as acute lymphoblastic leukaemia and various inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis and psoriatic arthritis.
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Increasing oversight of API manufacturing through international collaborationThe European Medicines Agency (EMA) and its European and international partners have successfully strengthened their interactions to improve the oversight of active pharmaceutical ingredient (API) manufacturers worldwide, as highlighted in the International API inspection programme report for 2011-2016, published today. APIs are the substances responsible for the activity of a medicine.
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Redistribution of UK’s portfolio of centrally authorised productsThe EU27 Member States and the European Medicines Agency (EMA) have completed the reallocation of the medicines for which the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) and Veterinary Medicines Directorate (VMD) are currently rapporteur or co-rapporteur appointed by the scientific committees to coordinate the evaluation of a medicine.
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Transitional period applicable to the new Regulations of Medical Devices and In Vitro Diagnosis Medical DevicesIn the context of the group of Competent Authorities for Medical Devices and In Vitro Diagnosis Medical Devices in what concerns inspection of the market and clinical investigation (CAMD), a Task Force was established (CAMD Transition Sub Group), with the purpose of discussing the content, harmonize the interpretation and clarify the rules related to the transitional period applicable to the new Regulations of Medical Devices and In Vitro Diagnosis Medical Devices.
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Revised: guideline “Validation of Computerised Systems”Since the adoption of the first version of the “Validation of Computerised Systems” guideline in May 2009, most of the Network members have introduced computerised systems e.g. Laboratory Information Management Systems (LIMS) and electronic document management systems into their labs which have become commonly used working tools of the Network. For that reason and also based on experiences gained during Mutual Joint Audits, the guideline has been profoundly restructured and revised.
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Draft addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - First versionDraft: consultation open
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How to prepare for an inspection?GDP inspections by supervisory authorities have grown in number and intensity. Many partners in the distribution chain also have customer audits to face. What does the ideal preparation for a GDP inspection look like?
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MHRA GxP Data Integrity Definitions and Guidance for IndustryMHRA has produced draft GxP data integrity guidance for industry and we welcome your comments.
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Public consultation concerning the EU template for GMP non-compliance statementDeadline for comments: 15/05/2018
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Rapid implementation of the monograph Products of fermentation (1468).Due to the public health risk associated with histamine contamination, further requirements related to the quality of raw materials have been added to the Raw materials section of the monograph on Products of fermentation (1468). The implementation date for the revised monograph was 1 April 2018.
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FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapseThe U.S. Food and Drug Administration granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). MRD refers to the presence of cancer cells below a level that can be seen under the microscope. In patients who have achieved remission after initial treatment for this type of ALL, the presence of MRD means they have an increased risk of relapse.
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Technical expert seminar on pharmaceuticals related matters, following UK withdrawal (8 March 2018)The
European Commission DG SANTE convened a technical expert seminar on
pharmaceuticals related matters in order to discuss matters related to
preparedness of the UK withdrawal.
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Retinoids – new recommendations on the risks of teratogenicity and neuropsychiatric disordersThe European Medicines Agency (EMA) has completed its review of retinoid medicines, and confirmed that an update of measures for pregnancy prevention is needed. In addition, a warning on the possibility that neuropsychiatric disorders (such as depression, anxiety and mood changes) may occur should be included in the prescribing information for oral retinoids.
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EU recommendations for 2018/2019 seasonal flu vaccine compositionThe European Medicines Agency (EMA) has issued the European Union (EU) recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2018.
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 March 2018The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval, including one orphan medicine, at its March 2018 meeting.
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ECA Data Integrity Task Force issues Version 2.0 of Data Integrity GuideWith the authorities' increasing attention to data governance and data integrity the ECA's Data Integrity Task Force's just released version 2.0 of its Data Integrity Guide provides an ideal tool for implementing data integrity in practice.
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Clinical Trial RegulationThe way clinical trials are conducted in the European Union (EU) will undergo a major change when the Clinical Trial Regulation comes into application in 2019. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via an EU portal and database. The European Medicines Agency (EMA) will set up and maintain the portal and database, in collaboration with the Member States and the European Commission.
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Common issues identified during clinical trial applicationsThis guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
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Additional Data requested for New Applications in the Mutual Recognition and Decentralised Proceduresread more >
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FDA Adopts Final ICH M7(R1) Mutagenic Carcinogen GuidelinePotential or actual impurities in drugs should be studied for their mutagenic properties, according to a revision to an ICH guideline addendum on mutagenic carcinogens, now adopted by the FDA.
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European Pharmacopoeia Reference Standards recently released9 new Ph. Eur. Reference Standards (RS) were released in February 2018.
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FDA Releases Finalized Q&A Guidance on Choosing Chemical Drug Starting MaterialsThe FDA finalized a Q&A guidance clarifying the International Council for Harmonization’s November 2012 Q11 guidance on development and manufacture of drug substances — giving recommendations for information that should be provided in authorization applications for starting materials.
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CMDh procedural advice on changing the RMS - Track versionIn exceptional circumstances, a Marketing Authorisation Holder (MAH) may request a change of the Reference Member State (RMS). The change may be needed when a MAH or a subsidiary responsible for the communication on behalf of the MAH has been closed in the RMS, or when a medicinal product has more than one RMS for the different pharmaceutical forms of the medicinal product, or, subject to clear justification, due to the sunset clause in the RMS. These are examples and other reasons might be justified.
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Four more EU Member States benefit from EU-US mutual recognition agreement for inspectionsThe mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories is progressing as planned. The US Food and Drug Administration (FDA) confirmed the capability of four more EU Member States (Czech Republic, Greece, Hungary, and Romania) to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. There are now a total of 12 Member States whose inspection results the FDA can rely on to replace their own inspections.
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Revision of EU GMP Chapter 1 to enhance Quality Risk ManagementThe European Medicines Agency (EMA) is planning to revise Chapter 1 of the EU-GMP Guidelines. In the new document, risk-based approaches will be included to prevent drug shortages.
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FDA to Require GCP Compliance for Device Trials That Rely on Foreign Clinical DataNext year, the FDA will begin to require that data from medical device studies conducted outside the U.S. be gathered in accordance with good clinical practices, including review and approval from an independent ethics committee and well-documented informed consent.
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2018The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended five medicines for approval, including two orphan medicines, at its February 2018 meeting.
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New standards for haemophilia patients care in Council of Europe ResolutionThe Council of Europe’s decision-making body, the Committee of Ministers, adopted Resolution CM/Res(2017)43 on principles concerning haemophilia therapies at the end of 2017. Elaborated by the European Committee on Blood Transfusion (CD-P-TS) on the basis of the recommendations from the Wildbad Kreuth Initiative IV meeting « Optimal use of clotting factors and platelets » of 2016*, the new Resolution replaces Resolution CM/Res (2015)3 on the same subject and calls on governments to take into account specific principles for the treatment of haemophilia and care for haemophilia patients.
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Medical devices: UK notified bodiesUK notified bodies listed under medical device directives.
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EMA's GMP Plans for 2018The European Medicines Agency has published the 2018 Work Plan. The EMA plans some new guidance and some revisions to existing requirements.
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Highlights from the twelfth industry stakeholder platform on the operation of pharmacovigilance in the European Unionread more >
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New versatile reference standard for equipment qualificationThe EDQM announces the availability of a new reference standard: Sodium aminosalicylate dihydrate for equipment qualification CRS 1 replacing the former Amoxicillin trihydrate for performance verification CRS, which will be discontinued as of 1 April 2018.
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Health-EU Newsletter - Assessing health technology in the EU: Commission proposes to reinforce cooperation amongst Member Statesread more >
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Quality Risk Management: What Inspectors are looking forICH Q9 is the major guideline providing principles and examples of tools for Quality Risk Management (QRM). But how do competent authorities look at these systems in their GMP inspections?
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FDA Publishes Guidance on Microbiology Data for Antibacterial DrugsSponsors of systemic antibacterial drugs should evaluate their products against test panels of relevant bacteria and against approved drugs with similar mechanisms of activity, the FDA said, in a newly revised guidance.
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How is the Data Governance System to be implemented in your Company?The PIC/S draft guideline "Good Practices for Data Management and Integrity" requires every company to have a data governance system in place in addition to their existing QM system. But how can such a system be implemented?
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Question & Answers on Chapter 1 QUALITY MANAGEMENT of the EU Good Distribution Practice GuidelineThe European GDP Guideline which has been published in a revised version on 7 March 2013 has caused a lot of discussion since then. Many requirements leave room for interpretation. On the GDP Association Webpage a section has been set up with frequently asked questions (FAQs).
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UK and China sign Memorandum of Understanding on Medicine and Device RegulationThe agreement pledges new areas of cooperation such as an exchange of learning from the accelerated access review (AAR) and how to effectively regulate the trading of medicines online.
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Evaluation of advanced therapy medicinesThe European Medicines Agency (EMA) has updated its procedural advice on the evaluation of advanced therapy medicinal products (ATMPs). The update aims to streamline some procedural aspects, strengthen collaboration between EMA’s scientific committees and address specific needs of ATMP developers in the evaluation procedure for initial marketing authorisations, to help developers of these medicines – often small and medium-sized enterprises (SMEs) or academic spin-offs – navigate the regulatory process in the EU.
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Regulatory requirements for Audit Trail ReviewsAudit Trails and their reviews are an important requirement in the current GMP policies. Specific requirements can be found in a number of guidelines, these days. Despite that, many questions about the specific implementation of this complex topic into practice remain.
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The EDQM "Guidance for electronic submissions for CEPs applications" has been revised and application forms have been updated accordinglyThe EDQM has revised the document «Guidance for electronic submissions for Certificates of Suitability (CEPs) applications».
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2018The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended seven medicines for approval, including one orphan medicine, at its January 2018 meeting.
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Ordinance no. 36/2018 – National Official Journal no. 19/2018, Series I of 2018-01-26Determines that the measures of treatment of patients with ichthyosis benefit from an exceptional reimbursement regimen.
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FDA Clarifies Conditions for Mixing, Diluting or Repackaging BiologicsThe FDA issued a final guidance on approved biologics that are mixed, diluted or repackaged, noting when the agency will not take action against violations of its standard rules on product misbranding and false and misleading labeling.
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EFSA confirms health concerns for hydroxyanthracene derivatives in foodSome substances belonging to a group of plant ingredients known as hydroxyanthracene derivatives can damage DNA and may cause cancer, said EFSA after assessing their safety when added to food.
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236 substances shortlisted for possible regulatory actionECHA has selected 236 substances for further scrutiny by the Member State competent authorities in its annual screening exercise. The competent authorities will carry out a manual examination of dossiers they prioritise to decide whether regulatory action is needed.
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Pharmeuropa Volume 30 No 1, January 2018Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 30.1 before 31st March 2018.
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International Drugmakers Plan for Higher Costs as Brexit LoomsTestifying before a UK House of Commons committee last month, international pharmaceutical companies said they are already hedging their bets when it comes to the real-world consequences of Brexit, making preparations for new hurdles in manufacturing and duplications of batch release testing that could cost millions of pounds per year. read more >
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New Annex 1: Consequences for the QPThe new draft of Annex 1 (Manufacture of Sterile Medicinal Products) will be much more extensive and contain some new rules and additions. There are also some things in the Annex 1 draft QPs need to consider.
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MHRA update to pharmaceutical companies on exit preparationsAn update from the Medicines and Healthcare products Regulatory Agency (MHRA) to pharmaceutical companies on preparations for exiting the European Union.
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Chair of EMA’s committee for orphan medicines receives award for outstanding patient engagementBruno Sepodes, Chair of the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP), has received the EURORDIS European Rare Disease Leadership Award as recognition of his commitment to involve patient advocates in all discussions and decisions related to orphan medicines.
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PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the marketEMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion across the European Union. These products are used as plasma volume replacement following acute (sudden) blood loss, where treatment with alternative products known as ‘crystalloids’ alone is not considered to be sufficient.
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FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric useThe U.S. Food and Drug Administration announced that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Labeling for the medications also is being updated with additional safety information for adult use – including an expanded Boxed Warning, the FDA’s most prominent warning ‒ notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.
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GMP Update - what's new in the EU?The GMP world was turning a bit slower in 2016 - now, it's picking up speed again. Currently, several crucial changes are being made with consequences even for national legislation. read more >
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Approval and Definition of Medicinal Products Prices – New formsThe forms for calculation of the prices of non-generic medicinal products from out-patient and hospital market, as well as of generic medicinal products, and their respective filling instructions have been updated. read more >
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MSs Recommendations on Extension Applications in Mutual Recognition and Decentralised Proceduresread more >
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PRAC recommendations on signals adopted at the PRAC meeting of 27-30 November 2017read more >
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Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug pricesThe FDA announced additional steps to encourage generic competition as part of the continued implementation of the Drug Competition Action Plan. read more >
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Pharmeuropa: Texts for commentsPharmeuropa issue 30.1 is now complete. Submit your comments until 31 March 2018. read more >
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FDA Clarifies Pathways for Medical Device AccessoriesFor the third time in under a year, the FDA issued a final guidance on medical device accessories, clarifying that a New Accessory Request can be included as part of a PMA, PMA supplement or a 510(k) submission. read more >
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FDA permits marketing of device to treat diabetic foot ulcersToday, the U.S. FDA permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers.
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Southern Member States update the guide concerning applications for market authorisation of phytopharmaceutical productsWorking Document on
the Work-sharing of the Southern Zone Member States under Regulation EC
1107/2009, revision 7.0.
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Extension of pilot for splitting of MRP/DCPsUpdate on the "Extension of pilot for splitting of
MRP/DCPs".
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Annual Price Revision for the Generic Medicinal Products 2018Binding Information Newsletter no. 171, from 22-12-2017.
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Annual Prices Revision 2018 - amendmentPhagecon hereby informs that Ordinance no. 359/2017, of 20 November, which proceeds with the definition of the reference countries, to be considered in 2018, for the authorisation of the prices of the new medicinal products and for purposes of annual prices revision of the hospital market and ambulatory market medicinal products, as well as it keeps, for the same year, the exceptional criterion to apply in the prices revision regimen, published in the National Official Journal, 1st series, no. 223, of 20 November 2017, has been amended. In the no. 2 of article 4, where it is read: «2 - From the suspension foreseen in the previous number are excluded the generic medicinal products which maximum PVP is higher than the maximum PVP of the reference medicinal product, being these subject to annual revision, in accordance with article 17 of Ordinance no. 195-C/2015, of 30 June, in its current wording.» it should be read: «2 - From the suspension foreseen in the previous number are excluded the generic medicinal products whose maximum PVP is higher than the maximum PVP of the reference medicinal products resulting from the 2018 annual revision, and those medicinal products should reduce the PVP in order not to overcome the price of the reference medicinal product.» We also inform that the amendment declaration was published in National Official Journal and is available at: read more >
https://dre.pt/web/guest/home/-/dre/114394848/details/maximized?serie=I&day=2017-12-22&date=2017-12-01
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Targeted stakeholders consultation on the revision of annex 1, on manufacturing of sterile medicinal products, of the Eudralex volume 4read more >
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Now online: Draft ICH Q12The long awaited and highly discussed ICH Q12 draft Guideline is now available online on the ICH website. read more >
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New WHO Guideline for Medical Devices and IVDsThe WHO has published a finalised 76-page regulatory framework for medical devices including in vitro diagnostic medical devices (IVDs) divided into 5 chapters. read more >
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Ph.Eur. Supplement 9.5 available nowThe 9.5 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 July 2018. read more >
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The associations representing the European and British life science industry have launched a joint policy document on the potential impact of the United Kingdom’s exit the European UnionOrganisations representing the life science industry in the EU and the UK have called for medicines to be a priority in phase 2 of the Article 50 negotiations. read more >
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European Pharmacopoeia Commission adopts a new monograph for Infliximab concentrated solution ‒ the first monograph on a monoclonal antibodyThe European Pharmacopoeia (Ph. Eur.) Commission has achieved an important milestone in the field of biotherapeutic products at its 159th Session, held in Strasbourg on 21-22 November 2017, with the adoption of the monograph for Infliximab concentrated solution (2928). read more >
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New FDA Guidance Narrows Agency Oversight of Digital Health ProductsThe FDA published three new guidances on digital health products that limit the types of products the agency will regulate as medical devices. read more >
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Suppression of the Test for Abnormal Toxicity from the European PharmacopoeiaDuring its 159th plenary session, held in Strasbourg on 21-22 November 2017, the European Pharmacopoeia Commission endorsed the complete suppression of the test for abnormal toxicity from the European Pharmacopoeia (Ph. Eur.). read more >
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Draft DIN EN ISO Injection Vials made of Tubular GlassThe DIN EN ISO committee published a draft for DIN EN ISO 8362-1 Injection vials made of glass tubing for comment. read more >
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Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to national authorised medicinal products for human useread more >
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FDA approves first biosimilar for the treatment of certain breast and stomach cancersThe U.S. Food and Drug Administration approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer.
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Track & Trace: New Questions and Answers published by the EUThe next version 8.0 of the catalogue containing questions and answers on practical implementation and technical aspects of serialisation requirements as per delegated act EU 2016/161 has become available on 22 November. Find more information about version 8.0 of the Q&A on EU FMD DR regarding serialisation. read more >
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Guidance to help pharma companies prepare for BrexitThe European Medicines Agency (EMA) has published additional guidance to help pharmaceutical companies to prepare for United Kingdom's (UK) withdrawal from the European Union (EU). read more >
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COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017Regulation on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council. read more >
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New EudraVigilance system is liveThe European Medicines Agency (EMA) has launched a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The new system makes it easier for marketing authorisation holders and sponsors of clinical trials to report suspected adverse reactions and allows for better analysis of this information for the benefit of patient safety in Europe. read more >
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GVP Update 2017There have been recent developments within EudraLex Volume 9 - Guidelines on good pharmacovigilance practices (GVP). read more >
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CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPsPublic consultation - comments should be sent to H-CMDhSecretariat@ema.europa.eu by 19 January 2018, coordinated where possible by trade associations. read more >
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Ordinance no. 359/2017 – National Official Journal no. 223/2017, Series I of 2017-11-20Proceeds to the definition of the reference countries to be considered in 2018 for the authorization of the prices of the new medicinal products and for effects of annual prices revision of the hospital market and outpatient market medicinal products, as well as it keeps, for the same year, the exceptional criterion to be applied in the prices revision regimen. read more >
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FDA's new Guidances on the Approval of Generic DrugsThe FDA has recently published various guidelines on application procedures for generics. read more >
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EudraVigilance: EMA's new Signal Management GuideIn line with the go-live date of the new EudraVigilance database EMA now published the revised GVP module IX on signal management. The revised module IX will introduce major procedural changes for industry. read more >
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Order no. 9879/2017 – National Official Journal no. 220/2017, Series II of 2017-11-15Determines the termination of the obligation of acquisition, by the entities of the National Health Service, of generics or biosimilar equivalent to those foreseen in the annexes to Orders no. 2326/2017, no. 9586/2016 and no. 10858/2015 and foreseen in the no. 2 of the referred orders, under the public procurement contracts (CPA), from the date that generic or biosimilar medicinal products reimbursed or with previous assessment decision equivalent to those foreseen in the annexes to the orders mentioned above are advertised by INFARMED - National Authority of the Medicines and Health Products. read more >
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Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory noteAdopted read more >
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2017The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended ten medicines for approval, including two orphan medicines, at its November 2017 meeting. read more >
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The ICH E11 Addendum on clinical investigation in children now enters into implementationThe International Council for Harmonisation, ICH, recently informed that the "E11(R1) Addendum on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 4 of the ICH Process in August 2017 and now enters into the implementation period (Step 5)". The "Addendum is proposed to address new scientific and technical knowledge advances in pediatric drug development and update the ICH E11 Guideline adopted in 2000". read more >
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Data Integrity from an Inspector's Point of ViewEven though the integrity of data has always been one of the basic principles of GMP, the topic has come more and more into the focus in inspections of the last 3-4 years. read more >
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Positive Balance for Implementation of the Falsified Medicines DirectiveThe soon-to-be required safety features for the realisation of the Falsified Medicines Directive must be implemented by February 09, 2019. The German initiative securPharm strikes a positive mid-term balance. read more >
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FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancerThe U.S. Food and Drug Administration expanded the approval of Zelboraf (vemurafenib) to include the treatment of certain adult patients with Erdheim-Chester Disease (ECD), a rare cancer of the blood. Zelboraf is indicated to treat patients whose cancer cells have a specific genetic mutation known as BRAF V600. This is the first FDA-approved treatment for ECD. read more >
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FDA to Recognize GMP Inspections From Eight EU CountriesThe FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency's requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year. read more >
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IMDRF Clarifies When Competent Authorities Can Share Confidential InformationThe International Medical Device Regulators Forum released final guidance that lays out procedures for sharing confidential postmarket surveillance for medical devices among regulators. read more >
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EU-FDA mutual recognition of inspections of medicines manufacturers enters operational phase1 November 2017 marks the coming into operation of further aspects of the mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories. This agreement, which updates the agreement from 1998, allows for recognition of each other's inspection outcomes and hence for better use of inspection expertise and resources. read more >
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FDA to Adopt ICH E9 Addendum on Clinical Trials AnalysesThe FDA is seeking public comments on an ICH addendum to a 1998 clinical trials statistics guideline focused on the use of sensitivity analyses and targets for estimation and measurement. read more >
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Position Paper concerning Applicants’ request of submission of multiple applications during ongoing DCPs or inclusion of new CMS or additional strength(s) in an already ongoing DCPMember states have been approached by applicants requesting submission of multiple applications during ongoing DCP or inclusion of new CMS or additional strength(s) in already started DCP procedures. This position paper provides the position reached by the CMDh. read more >
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Program of Early Access to medicinal products – new regulationDecree-Law no. 115/2017, of 7 September, which gave a new wording to article 25 of Decree-Law no. 97/2015, of 1 June, amended the conditions of exceptional use authorisation of medicinal products with marketing authorisation, establishing that, since the MA date and during the legally foreseen deadline for the previous assessment procedure, the supply of the medicinal products object of exceptional use authorisation is performed under the Early Access Program to medicinal products. read more >
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Summaries of scientific recommendations on classification of advanced therapy medicinal productsThe European Medicines Agency´s Committee for Advanced Therapies delivers scientific recommendations on whether a medicine can be classified as an advanced therapy medicinal product (ATMP). The Agency publishes the outcomes of these assessements in the format of summary reports.
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Specified Microorganisms - Harmonisation of the pharmacopoeial Chapters completedThe International Council for Harmonisation (ICH) finalized their recommendation relating to the use of pharmacopoeidal texts on tests for specified microorganisms. read more >
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PRAC recommendations on signals adopted at the 25-29 September 2017 PRAC meetingAdopted read more >
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New action plan to foster development of advanced therapiesThe European Commission's Directorate-General for Health and Food Safety (DG SANTE) and the European Medicines Agency (EMA) have published today a joint action plan to foster the development of advanced therapy medicinal products (ATMPs). The main aim is to streamline procedures and better address the specific requirements of ATMP developers. read more >
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FDA Issues Draft Bioequivalence Guidances for 30 Drugs, Revises 17The FDA published new product-specific draft guidances for 30 active ingredients - including cancer therapies, asthma treatments, epinephrine auto-injectors and anti-infectives - outlining the agency's preferred methods for supporting ANDA submissions. read more >
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FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphomaThe U.S. Food and Drug Administration approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL). read more >
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New EU GMP Guideline for IMPsThe EU Commission published two new GMP documents in the Official Journal of the European Union. read more >
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FDA Clarifies Approval Pathways for ANDA, 505(b)(2) Applications in New Draft GuidanceIn new draft guidance, The FDA describes which abbreviated approval pathways are available for ANDAs and 505(b)(2) applications. read more >
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ICH Finalizes Q&A Doc on Justifying Drug Starting MaterialsThe ICH finalized a Q&A document clarifying its advice on the selection and justification of starting materials used in drug manufacturing. read more >
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Ph. Eur. Supplement 9.4Supplement 9.4 of the Ph. Eur. is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of April 2018, and to follow the instructions given in the document. read more >
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EDQM and ANVISA sign Memorandum of Understanding on use of CEPs in BrazilThe European Directorate for the Quality of Medicines & HealthCare (EDQM) and ANVISA, the Health Surveillance Agency of Brazil, have signed a Memorandum of Understanding which lays the foundation for ANVISA to consider the use of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) for their evaluation of marketing authorisation applications (MAAs) for medicinal products. read more >
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Handling of Changes to Medical Device Products for approved Combination ProductsIn a recent news you could read about a question-and-answer document from the EMA, describing certain issues concerning the handling of changes after approval ("variations"). This document has been updated again. The topic of changes to medical devices after the approval of "combination products" has now been added. read more >
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Better labelling of excipients for safe use of medicinesThe European Medicines Agency (EMA) and the European Commission have updated the annex to the European Commission guideline on excipients in the labelling and package leaflet of medicinal products for human use. read more >
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Questions and Answers - ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological entities)This Question and Answer document is intended to provide additional clarification and to promote convergence and improve harmonisation of the considerations for the selection and justification of starting materials and of the information that should be provided in marketing authorisation applications and/or Master Files. The focus of the Q&A document is on chemical entity drug substances. read more >
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Changes in the presentation of translations of European and national registration proceduresImplementation of updates in the submission and loading of texts proposals with the medicinal product information and the translations for their revision during the national phase of marketing authorisation application procedures and subsequent variation procedures. read more >
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Medical devices: software applications (apps)Information on when software applications are considered to be a medical device and how they are regulated. read more >
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FDA improves access to reports of adverse drug reactionsThe U.S. Food and Drug Administration launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA's Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information. read more >
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Exploring opportunities for collaboration between regulators and healthcare payersThe European Medicines Agency (EMA) and European Union (EU) healthcare payers met for the first time on 19 September 2017 at EMA's offices in London to explore synergies and foster mutual understanding and cooperation to help improve timely and affordable access of patients to new medicinal products. The meeting aimed to be complementary to EMA's existing cooperation with health technology assessment (HTA) bodies and especially with EUnetHTA. read more >
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FDA Finalizes Guidance on Drug/Device Combination Product ClassificationsThe FDA finalized guidance on its process for assigning applications to a specific regulatory center, hoping to answer frequently asked questions from industry sponsors regarding whether their product will be classified as a drug or as a device. read more >
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Qualification of Development Tools for Medical Devices - Guidance for IndustryThe topic of development has been playing an important role for the FDA, not only in the pharmaceutical sector, but also with regard to medical devices for quite some time. An FDA draft guidance document on the qualification of development tools from 2013 has now been finalized. read more >
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Free Webinar on CEP Revisions - Sign up today!This webinar will outline the process for applying for revisions of CEP application files and give advice on how to obtain their fast acceptance. Learn about the revisions process, the correct classification of changes, and how to prepare and organise the documentation. read more >
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LC and GC columns in monographsWith a view to improving the correspondence between liquid chromatography column brand names and the reagents used to describe the stationary phases used with these columns, an overall review of all the monographs concerned has been undertaken. The names of the reagents and their definitions have also been reviewed to ensure that these stationary phases are described as clearly and consistently as possible.
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Ph.Eur. Supplement 9.4 available nowThe 9.4 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 April 2018. read more >
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MHRA delivers guidance on human factorsIn collaboration with key stakeholders, MHRA has produced guidance on the human factors aspects of design for medical devices including those in drug-device combination products. read more >
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European Medicines Agency guidance for applicants seeking scientific advice and protocol assistanceUpdated guidance. read more >
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Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human useread more >
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FDA approves first biosimilar for the treatment of cancerThe U.S. Food and Drug Administration approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer. read more >
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How to become a QP in EuropeBoth the ECA and the European QP Association are often contacted by people who would like to become a Qualified Person in a Member State of the European Union or outside the EU to release products for the EU market. Here is what you need to know about becoming a Qualified Person. read more >
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Ordinance no. 270/2017 and Ordinance no. 271/2017 – National Official Journal no, 176/2017, Series I of 2017-09-12Proceed to the first amendment, respectively, of: - Ordinance no. 195-A/2015, of June 30th, which approves the common procedure of the reimbursement and previous assessment of medicinal products; - Ordinance no. 195-B/2015, of June 30th, which regulates the determination of the homogeneous groups for purposes of the reimbursement in the reference prices system. read more >
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Infarmed Newsletter – Issue 63Access the new edition of Infarmed Newsletter. read more >
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FDA Releases Draft Guidance on Child-Resistant PackagingDrug companies must ensure their products meet federal standards for child-resistant packaging before labeling the packaging as child-resistant, the FDA said in draft guidance issued Aug. 2. read more >
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Test for Subvisible Particles: ICH Harmonisation CompletedWith Step 5, harmonisation regarding the use of pharmacopoeial methods for test for subvisible particles in the ICH regions has been completed. read more >
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Implementation of the safety devices in the human use medicinal productsThe requirement to place safety devices (device of prevention of adulterations and unique identifier) in the packages of certain medicinal products in order to allow the detection of falsified medicinal products in the legal circuit of the medicinal product and the individual identification of packages was introduced by Ordinance 2011/62/UE, Ordinance of the Falsified Medicinal Products and has to be implemented until 09 February 2019.
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Facilitating submission of post-approval dataThe European Medicines Agency has launched a new form to help marketing authorisation holders submit data generated to satisfy post-authorisation measures (PAMs) for centrally authorised products. read more >
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Draft ICH S5 (R3) guideline on reproductive toxicology: detection of toxicity to reproduction for human pharmaceuticals, step 2b - Revision 3Draft: consultation open read more >
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ICH Q4B - Harmonisation relating to the Sterility Test - General Chapters completedThe International Council for Harmonisation ICH Q4B - Harmonisation of pharmacopoeial chapters on Sterility Test with step 5 has now been finalized read more >
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Medical devices: EU regulations for MDR and IVDRWhat you need to know about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR). read more >
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FDA Draws Up Blueprint for Pre-Approval Facility ReviewsThe FDA has outlined plans for coordination between CDER and ORA in checking out the manufacturing facilities of drugmakers seeking approval for new pharmaceuticals. read more >
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Apply for manufacturer or wholesaler of medicines licencesHow to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines. read more >
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Revised Ph. Eur. Chapter TabletsRecently, the revised PH. Eur. Monograph Tablets (0478) has been published in Ph. Eur. Supplement 9.3. read more >
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Strengthening EU-US cooperation in medicine inspectionsThe European Commission (EC), the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment that allows the Us regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with EU regulators. This confidentiality commitment is a milestone in the ongoing implementation of the mutual recognition of inspections of medicine manufacturers and it aims to strengthen the EU-US relationship. Ultimately it will contribute to a more efficient use of inspection resources by regulators for the protection of human and animal health. read more >
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News questions and answers about safety features - Version 7 of the EU Q&As publishedThe soon-to-be mandatory safety features for the implementation of the Falsified Medicines Directive have to be implemented by February 9th, 2019. The European Commission has published Version 7 of the questions and answers about safety features in June 2017. read more >
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FDA’s Expedited Programs Predict Better Drugs, But Companies Are Still Slow to Confirm Benefits, Researchers SayThe FDA has largely succeeded in expediting the review of drugs with larger health gains, but postmarket trials by companies have fallen behind in confirming some of those benefits, with many not using the gold standard of randomized controlled trials, according to two independent studies. read more >
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Monthly report on application procedures guidelines and related documents for veterinary medicines: July 2017This report, which is updated every month, provides current information related to the volume and evaluation of pre and post-authorisation applications for medicinal products for veterinary use received by the European Medicines Agency. read more >
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What's new in pharmacovigilance - QPPV Update - Issue 2 - 2017Information on recent developments in EU Pharmacovigilance, relating to medicines for human use, and includes updates on the EU network activities and relevant projects. read more >
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Annual report of the Pharmacovigilance Inspectors Working Group for 2016This document is the ninth annual report of the Pharmacovigilance Inspectors Working Group. read more >
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New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 July 2017 PRACThe product information wording in this document is extracted from the document entitled "PRAC recommendations on signals" which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals. read more >
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Update - CMDh Best Practice Guide on the use of eCTD in the MRP/DCPTrack version. read more >
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Transparency and data quality: new cross-cutting EFSA guidance in a nutshellTwo new guidance documents - on the weight-of-evidence approach and biological relevance assessment - will help to further harmonise methodologies across the areas in which EFSA works. read more >
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Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategiesread more >
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USP monograph <1790>The long-awaited new monograph <1790> of the US Pharmacopoeia about the visual inspection of injections, which is supposed to be an explanation for the already valid chapter <790>, will finally come into force on August, 1st. read more >
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IUCLID Cloud launched – simpler for smaller companiesThe cloud version of the chemical data management tool IUCLID is now available for SMEs. Consultants helping SMEs with their registrations are welcome to subscribe too. In the cloud, you can prepare your REACH registration dossier directly online so there is no need for local installation. Reap the benefits of the cloud: data stored and safe at ECHA, automatic updates of IUCLID, fully managed back-ups, 24/7 availability of service. read more >
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Q&As on impact of EU-USA mutual recognition agreement on marketing authorisation applications and relevant variationsread more >
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API starting materials: EMA publishes updated reflection paperIn the recently published updated EMA reflection paper about starting materials, the passage about description of the manufacturing process of an API in an authorisation dossier has been revised. read more >
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Revised guideline on first-in-human clinical trialsThe European Medicines Agency (EMA) has revised its guidance on first-in-human clinical trials to further help stakeholders identify and mitigate risks for trial partcipants. read more >
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended eleven medicines for approval at its July meeting. read more >
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Ph. Eur. Supplement 9.3Supplement 9.3 of the Ph. Eur. is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of January 2018, and to follow the instructions given in the document HERE. read more >
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Mutual recognition agreementsThe European Union (EU) has signed mutual recognition agreements (MRAs) with third-country authorities concerning the conformity assessment of regulated products. Such agreements contain a sectoral annex on the mutual recognition of good manufacturing practice (GMP) inspections and batch certification of human and veterinary medicines. read more >
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EMA's updated Implementation Plan for the Introduction of Safety FeaturesThe soon-to-be required safety features for the execution of the Falsified Medicines Directive have to be implemented by February 9th, 2019. The EMA has published an updated plan for the implementation of safety features on the packaging of centrally authorized products for human use. read more >
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Order no. 6289/2017 - National Official Journal no. 137/2017, Series II of 2017-07-18Amends no. 4 of Order no. 5657/2017, published in National Official Journal, 2nd series, no. 123, of 28 June (clarifies the scope of application and establishes a quick and transparent procedure regarding the authorization applications underlying the provisions of article 9 of Decree-Law no. 5/2017, of 6 January). read more >
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Regulatory information – EMA improves its guidance for post-authorisation activitiesThe European Medicines Agency (EMA) has updated its best practice guidelines and support documents for marketing authorisation holders (MAHs) in the areas of type II variations, post-authorisation safety studies and changes related to quality aspects. read more >
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Questions and answers of scientific guidelineImproving the understanding of normal operating range (NOR), proven acceptable range (PAR), design space (DSp) and normal variability of process parameters. read more >
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What is GMP compliant Equipment Design?It's frequent question what GMP compliant equipment design is or how a system has to be made up in order to be GMP compliant and suitable for the manufacturing of medicinal products/APIs. There is a short and a long answer to these questions around GMP compliant equipment design. read more >
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European Union individual case safety report (ICSR) implementation guideThis guidance specifies the technical requirements and the process of transmission of Individual Case Safety Reports (ICSRs) and is applicable to all stakeholders, which are exchanging ICSRs electronically within the EEA. read more >
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New tools to potentially reduce need for animal testingEFSA recently launched its OpenFoodTox database of chemical hazards in food and feed. The database is a rich source of toxicological information for risk assessment that can potentially support the reduction of animal testing. read more >
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The launch of the new EudraVigilance systemThis document addresses questions received from stakeholders in preparation of the launch of the new EudraVigilance System, which is to go-live on 22 November 2017. read more >
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Data on medicines (ISO IDMP standards)The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). read more >
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Targeted stakeholder consultation on the experience acquired with the Paediatric RegulationResults of the public consultation on the Paediatric Regulation are now available. read more >
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EMA and EUnetHTA step up interaction to align data requirementsThe European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) are stepping up their efforts to provide developers of medicines with simultaneous, coordinated advice on their development plans and facilitate alignment of data requirements. read more >
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Pharmeuropa: Texts for commentsPharmeuropa issue 29.3 is now complete. Submit your comments before 30 September 2017. read more >
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Pre-submission checklist for type II variation applicationsThe Agency strongly recommends that this checklist is used in advance of submission of type II variation applications. You should be able to answer "Yes" to every item listed below unless a specific point is not applicable ("n/a") to the application in question. Please note that this checklist should not be included in the submission. read more >
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Decree-Law no. 5/2017, of 6 January – article 9 Establishments, Services and Bodies of the NHS and of the Ministry of Health and Communications Platform – Transparency and AdvertisingDecree-Law no. 5/2017, of 6 January, which approves the general principles of advertising to medicinal products and medical devices, establishes specific rules regarding the scientific actions to be performed in establishments, services and bodies of the National Health System (NHS) and of the Ministry of Health (MH) and to the reception of support and benefits from these entities, as well as it also does some changes in the regimen of obligations of communications foreseen in article 159 of the Portuguese Medicinal Products Statute, approved by Decree-Law no. 176/2006, of 30 August, and in article 52 in Decree-Law no. 145/2009, of 17 June, recently become effective. read more >
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The MEDICRIME Convention in a few wordsThe EDQM plays a major role in implementing and monitoring the Council of Europe Convention on falsified medical products and similar crimes involving threats to public health, known as the MEDICRIME Convention. read more >
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EDQM publishes its 2016 Annual ReportThe EDQM has just published its 2016 Annual Report. The report is an opportunity to review the different activities of the past year and reflect on what the EDQM accomplished and developed. In her foreword, EDQM Director, Dr Susanne Keitel, comments on the year's events, achievements, and thanks all involved for their dedication, expertise and support. read more >
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The user manual of EudraVigilance Web reporting tool EVWEB (version 1.0) is now available
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Two new medicines recommended for the treatment of chronic hepatitis CThe European Medicines Agency has recommended granting marketing authorisations in the European Union (EU) for Maviret and Vosevi, two new medicines indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults. read more >
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FDA Pediatric Cancer Panel Suggests More International Research CollaborationIn the second day of a two-day meeting, an FDA pediatric cancer advisory panel suggested further international cooperation and emphasized the need for tailoring trials to their specific diseases, while recommending against the use of placebos in pediatric cancer drug trials. read more >
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ICH M7(R1) Addendum reaches Step 4 of the ICH ProcessThe ICH M7(R1) Addendum reached Step 4 of the ICH process in May 2017 and now enters into the implementation period (Step 5). read more >
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Implementation of the Falsified Medicines DirectiveVersion 7 of "Questions and Answers" document regarding the implementation of the rules on the safety features for medicinal products for human use is now available. read more >
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Pharmacovigilance LegislationThe Q&A on the Pharmacovigilance legislation have been updated. Please find it in the track version of the document in force. read more >
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European Medicines Agency’s interaction with industry stakeholders - Annual report 2016read more >
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SCCS - Request for a scientific opinionSubmission II on the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products. read more >
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Applications pilot: dedicated support for small and medium-sized enterprisesEFSA has launched a new support initiative for applicants from small and medium-sized enterprises (SMEs). In the next six month, SMEs in the areas of feed additives and novel foods (excluding traditional food) can request an administrative check of their draft dossiers prior to submission. The support will be provided via teleconferences. read more >
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REACH tests need to comply with good laboratory practiceECHA reminds registrants that all toxicological and ecotoxicology tests need to be carried out in compliance with good laboratory practice (GLP). read more >
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Concept paper on the need for the development of a reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)Draft: consultation open read more >
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Regulatory guidance for industry to prepare for the UK’s withdrawal from the EUThe European Medicines Agency (EMA) and the European have published guidance to help pharmaceutical companies to prepare for the United Kingdom´s withdrawal from the European Union. The guidance relates to both human and veterinary medicines. read more >
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Substance not in the review programme? Check if you can still use itA list of those active substances not covered by the review programme that can continue to be used in biocidal products is now available. read more >
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Simplex + 2016 ProgramInfarmed has implemented 9 measures within the scope of the Simplex + 2016 Program. read more >
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Drugmakers Seek Clarifications of FDA’s Interchangeability GuidanceMore drugmakers have weighed in on the FDA´s draft guidance on biosimilar interchangeability, urging the agency to make clear the designation does not mean a product is superior in terms of safety or efficacy. read more >
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Medicines: apply for a parallel import licenceHow to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application. read more >
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Decide if your product is a medicine or a medical deviceHow the Medicines and Healthcare products Regulatory Agency (MHRA) makes decisions on what is a medicine or medical device (borderline products). read more >
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European Pharmacopoeia: supplements 9.1 to 9.5 and new downloadable version available to orderSupplements 9.1 to 9.5 of the European Pharmacopoeia are now available to order on the EDQM store. These supplements, which are expected to be ready for dispatch during June, contain all the regulatory information that will come into force in the course of 2018. They complement the 9th Edition launched last year and bring the total number of monographs to 2351 (including dosage forms), along with 361 general texts (including general monographs and methods of analysis) and around 2670 descriptions of reagents. read more >
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EudraVigilanceEMA will launch a new EudraVigilance system with enhanced functionalities for reporting and analysing suspected adverse reactions in November 2017. read more >
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Chemistry of active substances (chemistry of new active substances)This document describes the type of information required for the manufacture and control of active substances (existing or new chemical entities) used in a medicinal product. Effective from 21/05/2017. read more >
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May Newsletter publishedIn the May issue of the ECHA Newsletter, you can read expert views on how close we are to end animal testing, how safe artificial pitches are and how you can now find safer chemicals online. read more >
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EudraVigilance Data Analysis System (EVDAS)User registration steps for EU QPPVs or trusted deputies (for the purpose of the EudraVigilance registration process). read more >
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European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changesThis guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency´s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. read more >
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Report of the consultation - Public consultation on strengthening EU cooperation on Health Technology Assessment (HTA)read more >
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Ordinance no. 111/2017 - National Official Journal No. 93/2017, Series II of 2017-05-15Adds the annex to Ordinance no. 158/2014, of 21 February, which reviews the special reimbursement regimen for medicinal products meant for the treatment of the hepatitis C disease, adding the medicinal product containing the substance Sofosbuvir + Velpatasvir. read more >
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Progress on science, medicines and healthThe European Medicines Agency's (EMA) 2016 annual report focuses on the Agency's key achievements in the areas of medicine evaluation, support to research and development of new and innovative treatments and the safety monitoring of medicines in real life. read more >
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Nitrogen Use in pharmaceutical ProductionNitrogen often comes in contact with a product during manufacturing and is therefore relevant for its quality, especially when it comes to the manufacture of sterile products. Nonetheless, the use of nitrogen is significantly less specified than that of pharmaceutical water. Parameters and limits have to be defined by the pharmaceutical users themselves. read more >
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Press Release – Ministers of six countries sign unprecedented agreement for access to medicinal productsThe Ministers of Health of six European countries, including the Minister of Health Adalberto Campos Fernandes, signed yesterday the La Valletta Declaration, an unprecedented agreement that aims to ensure patient access to innovative medicinal products and, at the same time, the sustainability of the healthcare systems. read more >
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Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devicesAmending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. read more >
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Now Official: Revised USP Plastic Packaging Chapters <661.1> and <661.2>The USP Expert Committee General Chapters - Packaging and Distribution posted on April 28, 2017, the previously announced Revision Bulletins, Postponement, regarding general chapters <659>, <661>, <661.1> and <661.2>. The revisions of the four general chapters have become official on May 1, 2017. read more >
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Draft Addendum of the ‘ICH E11(R1) guideline on clinical investigation of medicinal products in the paediatric population’ (EMA/CPMP/ICH/2711/1999)Overview of comments received by the European Medicines Agency read more >
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Drug Safety Update: monthly newsletterMonthly PDF editions of the
Drug Safety Update newsletter from MHRA and its independent advisor the
Commission on Human Medicines.
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Instruction document of the Spanish Agency for Medicinal Products and Medical Devices for conducting clinical trials in SpainIn this instruction document of the Spanish Agency of Medicinal Products and Medical Devices for conducting clinical trials in Spain is provided, in a questions and answers format, information on the practical aspects that entail the application of the Royal Decree 1090/2015, of 4 December, highlighting the differences concerning the previous royal decree. read more >
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PUBLISHING OF THE GLOBAL STATISTIC DATA OF THE YEAR 2016 (RESULTS ON 31/12/2016)The global statistic data of the year 2016 (results on 31/12/2016) are published, available in the spacer Indicators CEIC. The indicators regarding Clinical Trials with Medicinal Products, Clinical Trials with Intervention of Medical Devices and Financial Contracts of Studies approved by CEIC are available. read more >
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Draft guideline on good clinical practice compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trialsDraft: consultation open read more >
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What's new in Pharmacovigilance - QPPV Update - Issue 1 - 2017This is the first issue of QPPV Update in 2017. It provides Qualified Persons responsible for Pharmacovigilance (QPPVs) and all other people working in pharmacovigilance with an update on EU Pharmacovigilance. read more >
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Position (EU) No 2/2017 of the Council at first readingAdoption of a Regulation of the European Parliament and of the Council on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC read more >
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FDA approves two hepatitis C drugs for pediatric patientsThe U.S. Food and Drug Administration approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Solvaldi were previously approved to treat HCV in adults. read more >
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Optimising safety information for medicines in Europe throughout product lifecycleFollowing two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the European Medicines Agency (EMA) has issued additional guidance and recommendations as part of its commitment to continuous process improvement. read more >
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EMA revises Guide on Pharmaceutical WaterAccording to the European Pharmacopoeia, it is allowed as of the 1st of April 2017 to produce water for injection (WFI) using cold i.e. non-distillation methods. Now, the European Medicines Agency EMA has published a concept paper on the revision of the "Note for Guidance on Quality of water for pharmaceutical use". read more >
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PRAC recommendations on signals adopted at the PRAC meeting of 6-9 March 2017Adopted read more >
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CMDh Best Practice Guidance on collaboration between Member States in relation to serious GMP non-compliance issuesThe aim of this Best Practice guide is to facilitate the collaboration among MSs in the Coordination Group for Mutual Recognition and Decentralised Procedure (human), CMDh, on serious GMP issues notified to the group. read more >
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Clinical development of fixed combination medicinal productsAdopted guideline read more >
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Good pharmacovigilance practicesGood pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level. read more >
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CMDh procedural advice on changing the RMSIn exceptional circunstances, a Marketing Authorisation Holder (MAH) may request a change of the Reference Member State (RMS). read more >
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EMA Q&A on GCPThe European Medicines Agency (EMA) recently published Questions and Answers on good clinical practice (GCP) on its website. read more >
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Scientific guidelines with summary-of-product-characteristics recommendationsUpdate read more >
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COMMISSION IMPLEMENTING REGULATION (EU) 2017/556, of 24 March 2017, on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the CouncilText with EEA relevance read more >
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Use of big data to improve human and animal healthTogether with the heads of the national competent authorities in the European Economic Area (EEA), known as Heads of Medicines Agencies (HMA), the European Medicines Agency (EMA) has established a new task force to explore how medicines regulators in the EEA can use big data to support research, innovation and robust medicines development in order to benefit human and animal health. read more >
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New portal “Information System for the Assessment of the Health Technologies – SIATS”As from today, 23rd March, the new SIATS (Information System for the Assessment of the Health Technologies) portal is available, which will allow the MA holders and their representatives to manage the medicinal products accessibility. read more >
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Annex 16 QP Certification: important Questions and AnswersWhat can a Supply Chain Diagram look like? How to rely on vendor-supplied samples? These are just two examples of questions being frequently asked in connection with the new Annex 16 of the EU-GMP Guidelines (Certification by a Qualified Person and Batch Release). read more >
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Agenda - CHMP agenda of the 20-23 March 2017Draft agenda for the meeting on 20-23 March 2017 read more >
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2016 annual report on EudraVigilance for the European Parliament, the Council and the CommissionThis Annual report is prepared in accordance with EU legislation and summarises the EudraVigilance related activities performed in 2016. read more >
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Quality of medicines questions and answers: Part 1These questions and answers address a number of questions that have been brought to the attention of the Joint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working Party (QWP) by marketing-authorisation holders (MAHs) or European Economic Area (EEA) competent authorities, on matters related to the quality of medicines. They have been developed and are maintained by the QWP. read more >
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Launch of SPOR data management servicesThe European Medicines Agency (EMA) is preparing data management services in the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) data. The SPOR services will support the implementation of the standards developed by the International Organization for Standardization (ISO) for the identification for medicinal products (IDMP). read more >
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EMA Paper on Dissolution Specification for Generic Products publishedThe EMA published the draft of the "Reflection paper on the dissolution specification for generic oral immediate release products". read more >
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Variations to the terms of MA: National ProcedureFrequently Asked Questions - National Variations read more >
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Regulatory cooperation to improve global healthHow to improve the availability of high quality, safe and effective medicines to patients in countries beyond Europe and how to make better use of existing tools? These were two of the questions discussed at a workshop jointly organised by the European Medicines Agency (EMA) and the Maltese Presidency of the European Union (EU) that brought together regulators from across the EU and Africa in Malta on 2 and 3 March 2017. read more >
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EC Report Recommends Policy Actions on Off-Label UseRegulations on off-label use are not harmonized across the European Union - only 10 out of 21 surveyed member states have specific policies, according to a European Commission report read more >
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Implementation strategy of ICH Q3D guidelineThe purpose of this document is to address specific considerations to enable the practical implementation of ICH Q3D Guideline for Elemental Impurities in the European Union. read more >
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Sterile plastic containers for human blood and blood componentsA draft of Ph. Eur. chapter 3.2.3 Sterile plastic containers for human blood and blood components has been published for comments in Pharmeuropa 29.2. Deadline for comments is June 30, 2017. read more >
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Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V)Draft: consultation open read more >
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CEIC Guideline on the SUPPLY OF THE MEDICAL DEVICE IN THE SCOPE OF CLINICAL STUDIES WITH INTERVENTIONIn the CEIC website, in the spacer Guidelines the CEIC Guideline on the SUPPLY OF THE MEDICAL DEVICE IN THE SCOPE OF CLINICAL STUDIES WITH INTERVENTION is published. This document was approved in plenary meeting on 20th February and published on 24th February. read more >
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Mutual recognition with the United StatesAuthorities in the European Union (EU) and the United States (US) have put in place a mutual recognition agreement (MRA) on good manufacturing practice (GMP) inspections. The aim of the agreement is to encourage greater international harmonisation, make better use of inspection capacity and reduce duplication. read more >
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PRIME: priority medicinesPRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. read more >
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Delegate Regulation on the Anti-Counterfeiting DirectiveNew EU Requirements and State of Implementation
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Adaptive PathwaysReport on a meeting with stakeholders held at EMA on Thursday 8 December 2016. read more >
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Best Practice Guide on the Assessment Report for Mutual Recognition and Decentralised ProceduresUpdate read more >
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New downloadable version of the European PharmacopoeiaWith the publication of Supplement 9.3 the USB version of Ph.Eur. will be replaced by a downloadable version. read more >
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The ICH Q11 draft Q&A presentation available now on the ICH websiteThe ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), regarding the selection and justification of starting materials, reached Step 2b of the ICH Process in November 2016 and now enters the consultation period. A training presentation has also been developed by the expert Working Group. read more >
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Questions and answers: Good manufacturing practiceEuropean Medicines Agency´s answers to frequently asked questions, as discussed and agreed by the Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group (Update). read more >
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Concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal productDraft: consultation open read more >
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EDQM on biosimilars: Ph. Eur. monographs are flexible and evolving standardsDuring a seminar coorganised with the European Medicines Agency (EMA), the EDQM clarified further the role that Ph. Eur. monographs play in the assessment of biosimilars. As public standards for the quality of medicines in Europe, monographs ensure the quality of biosimilar and other biotherapeutic products, but compliance with them is not sufficient for demonstrating biosimilarity. However, while Ph. Eur. monographs provide specifications in the form of tests and acceptance criteria for all medicines, they are dynamic documents that can be adapted to scientific progress. read more >
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Ordinance no. 1542/2017 – National Official Journal no. 33/2017, Series II of 2017-02-15Defines the concept of "insignificant valuables and relevant for the practice of the healthcare professional " providing its uniform fixation, in the scope of the sectors of the medicinal product and of the medical devices. read more >
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Revised document published on Management of applications for new CEPs and revisions/renewals of CEPs.The document PA/PH/CEP (13) 110 which described the policy for assessment of CEP applications has been revised following a review of current practice. read more >
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Press Release – Europe begins safety assessment of quinolones (antibiotics)The European Medicines Agency (EMA) began the safety review of the quinolones and fluoroquinolones, which are broad spectrum antibiotics used in the treatment of severe bacterial infections. The purpose of this review - which originated a newsletter published at Infarmed´s website - is to assess the duration of severe adverse reactions that affect the muscles, the joints and the nervous system. read more >
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New MedRegs blogMHRA has launched an official blog providing expert insight into the latest regulatory thinking and all aspects of medicines regulation. read more >
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Annual report on the use of the special contribution for orphan medicinal productsPatients suffering from rare diseases deserve access to the same quality of medicinal products as other patients within the European Union (EU). The incentives laid down in the orphan legislation aim to simulate sponsors to develop medicinal products for rare diseases. Medicinal products eligible for incentives are identified throught the EU procedure of orphan designation. The orphan designations cover a wide variety of rare diseases, including genetic diseases and rare cancers, for which there are limited treatment options, a large number of these diseases also affect children. read more >
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Support for applications on Article 58EMA has in place a range of regulatory tools to support applicants in the development and submission of applications for medicinal products relevant to Article 58. read more >
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Agenda - Pharmacovigilance Risk Assessment Committee (PRAC)Draft agenda for the meeting on 6-9 February 2017 read more >
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Guideline on core SmPC and Package Leaflet for nanocolloidal technetium (99mTc) albumin - First versionAdopted read more >
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Summaries of scientific recommendations on classification of advanced therapy medicinal productsThe European Medicines Agency´s Committee for Advanced Therapies delivers scientific recommendations on whether a medicine can be classified as an advanced therapy medicinal product (ATMP). The Agency publishes the outcomes of these assessements in the format of summary reports. read more >
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Clinical data for two more medicines now available onlineThe European Medicines Agency (EMA) has published clinical data for two additional medicines on its clinical data website. This follows the launch of the website on 20 October 2016 and is in line with the Agency's policy on the publication of clinical data. read more >
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Elemental Impurities: The Next Steps for the Implementation of ICH Q3D into the European PharmacopoeiaThe EDQM has published the next steps for the implementation of the ICH Q3D guideline in the European Pharmacopoeia. read more >
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Transparency platform – Specific rules for the establishments, services and organisms of the NHS and of the Ministry of Health (Decree-Law no. 5/2017, of 6 January – Article 9)Decree-Law no. 5/2017 approves the general principles of the advertising to medicinal products and medical devices.
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2017The European Medicines Agency´s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its January meeting. read more >
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Post-orphan medicinal product designation procedures: guidance for sponsorsThe opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the European Medicines Agency (EMA). read more >
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Medicine evaluation figuresThe European Medicines Agency (EMA) publishes information on the volume and outcome of marketing authorisation and post-authorisation applications for human and veterinary medicines that it evaluates. read more >
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GMP Outlook for 2017 (Part 2)There are many new developments and change notifications in the GMP area kepping the pharmaceutical industry busy, not least because many of the new requirements must be implemented soon. read more >
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The M4(R4) presentation available now on the ICH WebsiteThe Common Technical Document (CTD) is organised into five modules, including as an Annex the Granularity document that provides guidance on document location and paginations. In June 2016, this Annex was revised to add Module 2 and 3 tables and Appendices for eCTD v4, as well as, corrections to Module 2 and 3 tables for eCTD v3.2.2. read more >
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Update of application forms “Request for new CEP” and “Request for revision or renewal of CEP”The application forms for the submission of new Certificate of Suitability applications and for requests for revision or renewal have been slightly revised in order to remove the reference to the EDQM Dropbox and submission of CD-ROM/DVD. Applicants should use the CESP (Common European Submission Portal) to submit documentation to EDQM. read more >
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The Q3C(R6) Step 4 presentation available now on the ICH WebsiteThe Q3C Guideline recommends the use of less toxic solvents in the manufacture of drug substances and dosage forms, and sets pharmaceutical limits for residual solvents (organic volatile impurities) in drug products. read more >
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Good manufacturing practice and good distribution practiceComply with good manufacturing practice (GMP) and good distribution pratice (GDP), and prepare for an inspection. read more >
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Revised USP Chapter on Analytical Instrument QualificationThe USP has released a revision of Chapter on Analytical Instrument Qualification. This chapter set the fundamental requirements on the qualification of different types of instruments in the laboratory. read more >
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Update on the Ph. Eur. policy on elemental impuritiesWith the implementation of the ICH Q3D guideline on elemental impurities, the control of elemental impurities is undergoing a shift in paradigm, moving away from pure substance-based testing towards a holistic control strategy in the finished product. While these approaches are not contradictory, this change has triggered the revision of numerous texts in the European Pharmacopoeia (Ph. Eur.). read more >
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Human medicines highlights - January 2017This newsletter provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency. read more >
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GMP Update - what was new in 2016?"You get the impression that GMP is developing faster and faster". During the past year, the world of GMP turned somethat slower. Its developments in the GMP environment remain interesting though. read more >
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ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6ICH is inviting public review and comment on a reflection paper on Good Clinical Pratice (GCP) "Renovation", which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct. read more >
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IMDRF publishes Guidance Draft on Clinical Studies with Software as a Medical DeviceThe IMDRF (International Medical Devices Regulator Forum) is the sucessor organisation of the Global Harmonisation Task Force (GHTF). Recently, the IMDRF has published a guidance draft entitled "Software as a medical Device (SAMD): Clinical Evaluation". read more >
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Setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilitiesUpdate read more >
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New Chapter on Chemical Imaging in the Ph. Eur.The chapter on Chemical Imaging (5.24) was adopted by the European Pharmacopoeia Commission at the end of November 2016. The Vibrational Spectroscopy and Analytical Data Modelling working party (VSADM) has produced the first such chapter to be included in any pharmacopoeia worldwide. This general chapter is intended to further the use of Chemical Imaging (CI) for analysing pharmaceutical products in formulation and analytical development, quality control and manufacturing environments. The final text will be published in Supplement 9.3 in July 2017. read more >
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Decree-Law no. 5/2017 – National Official Journal no. 5/2017, Series I of 2017-01-06Approves the general principles of the advertising to medicinal products and medical devices. read more >
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PRAC recommendations on signals adopted at the PRAC meeting of 28 November-1 December 2016Adopted read more >
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FAQ VALIDATION – CHANGE OF PRINCIPAL INVESTIGATORA new validation FAQ is published, regarding the change of principal investigator. read more >
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FDA Clarifies Scope of Major Deficiencies in ANDA Refuse-to-Receive GuidanceThe FDA has again updated on its criteria for refusing to receive an ANDA, providing a broader definition for major deficiencies and downgrading four major deficiencies to minor ones in order to make requirements less burdensome for industry. read more >
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FDA Tweaks Guidance on Clinical Pharmacology Data for Demonstrating BiosimilarityThe FDA has made modest changes to its guidance on clinical pharmacology testing for biosimilars. read more >
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Direct action antiviral (hepatitis C) – final recommendationsThe Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed the recommendations disclosed in Newsletter no. 167/CD/550.20.001, of 05/12/2016. read more >
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Order no. 16029/2016 – National Official Journal no. 246/2016, Series II of 2016-12-26Public consultation on the Regulation variation Project regarding Prior Notice of Medicinal Product Transactions Abroad. read more >
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Revision of PIC/S GMP Guide (PE 009-13)Chapters 1, 2, 3, 6 & 7 of the PIC/S GMP Guide have been revised. read more >
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Ordinance no. 331/2016 - National Official Journal no. 244/2016, Series I of 2016-12-22Establishes an exceptional reimbursement regimen for the medicinal products intended for the treatment of moderate to severe oncological pain. read more >
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Sistema de Preços de Referência - 1.º trimestre de 2017A lista dos Grupos Homogéneos e dos preços de referência unitários a vigorar no 1º trimestre de 2017 foi aprovada pela deliberação nº 77/CD/2016, de 19 de dezembro de 2016 do Conselho Directivo e entra em vigor a 1 de janeiro de 2017. read more >
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European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changesThis guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency´s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. read more >
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2016The European Medicines Agency´s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines for marketing authorisation at its December 2016 meeting. This brings the total number of medicines recommended for approval by the CHMP in 2016 to 81. read more >
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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline Q3C (R6) on impurities: guideline for residual solvents - Step 5This document recommends acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. It recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents. read more >
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API-mix and CEPsEDQM has published the document "API-Mix (or mixtures) and CEPs" with regards to the acceptance of applications for CEPs where associated monograph of the European Pharmacopeia is for a mixture of an API and excipient. This clarifies the acceptability of such applications in line with the EMA Q&A on this subject which is referenced in the documnet. In addition it provides some clarification on information to be provided in the application and the information ehich will be included on the CEP for such substances. read more >
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EMA hosts workshop on adaptive pathwaysThe European Medicines Agency (EMA) has hosted a workshop with stakeholders to discuss adaptive pathways, an approach to medicines development that aims to facilitate access to medicines that address patients' unmet needs. read more >
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FDA Perspective on Risk Management and its Influence on Quality - Inspection Deficiencies 2015In the framework of a conference on Quality and Manufacturing, David J. Jaworski, Senior Policy Advisor of CDER´s Office of Manufacturing and Product Quality gave a presentation on risk management and its influence on quality. The slides of his presentation are now freely available. read more >
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Human medicines highlights - November 2016This newsletter provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency. read more >
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Selection and justification of starting materials: new Questions and Answers to ICH Q11 publishedThe ICH Q11 Guideline describing approaches to developing and understanding the manufacturing process of drug substances was finalised in May 2012. Since then the pharmaceutical industry and the drug substance manufacturers had time to get familiar with the principles outlined in this guideline. However, experience has shown that there is some need for clarification. Thus the Q11 Implementation Working Group recently issued a Questions and Answers Document. read more >
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New monograph on sodium pertechnetate (99mTc) injection (accelerator-produced) adoptedAt its 156th Session the European Pharmacopeia Commission adopted the monograph on Sodium pertechnetate (99mTc) (accelerator-produced) injection (2891). read more >
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Implementation of ISO IDMP standards - UpdateThe European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). Following a phased implementation process, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these formats and terminologies. read more >
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Highlights 156th session of the Ph. Eur. CommissionFourteen new texts and 52 revised monographs were adopted and the Ph. Eur. implementation strategy of the ICH Q3D guideline on elemental impurities was fine tuned. read more >
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Evaluation of the EMA fee system – terms of reference for external contract.DG SANTE has contracted out a study to support the evaluation of the fee system of the European Medicines Agency. The project will start in December 2016 and will last for 15 months. read more >
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Active pharmaceutical ingredients: Japan joins international collaboration on GMP inspectionsThe ongoing collaboration on good manufacturing practice (GMP) inspections of active-pharmaceutical-ingredient (API) manufacturers between the European Medicines Agency (EMA) and its international partners is to be expanded to include Japan´s Pharmaceutical and Medical Devices Agency (PMDA). read more >
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ORDER NO. 14202A/2016 – NATIONAL OFFICIAL JOURNAL NO. 227/2016, 1st SUPPLEMENT, SERIES II OF 2016-11-25Under the scope of the National Programme for Prevention and Control of Smoking and of the Programme-type of action in Stopping Smoking, from the Directorate-General of Health, until the end of the year 2016 and during the year 2017, priority is given to the acess to nicotine-replacement medicinal products and to the reimbursement of the anti-smoking medicinal products subject to medical prescription. read more >
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Non-animal methods now a default for skin sensitisation – submit correct informationThe new REACH requirements for skin sensitisation entered into force on 11 October 2016 making non-animal testing the default requirement. Remember to take this change into account when submitting information to ECHA, otherwise your dossier will not pass the completeness check. read more >
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Pharmacopoeial Discussion Group (PDG) AchievementsThe meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), and the United States Pharmacopeia (USP)] was hosted by JP in Tokyo, Japan, 24-26 October 2016. To date, 30 of the 36 General Chapters and 49 of the 67 excipient monographs on the current work programme have been harmonised. Sign-offs at this meeting include a new general chapter on Colour (Instrumental method) and a revised general chapter on Amino Acid Determination. read more >
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Guideline on the chemistry of active substancesThis guideline replaces "Note for guidance on chemistry of new active substances" (CPMP/QWP/130/96, Rev 1) and "Chemistry of active substances" (3AQ5a). read more >
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Regulatory information – New guidance on type II variations and marketing authorisation extensions for orphan-designated medicinesThe European Medicines Agency (EMA) has updated its post-authorisation guidance on extensions of marketing authorisations and type II variations to include further details on the information companies need to provide when submitting a type II variation or a marketing authorisation extension for an orphan-designated medicine. read more >
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RNEC – New way of electronic submission, registration and disclosure of clinical studiesThe electronic platform for registration and disclosure of clinical studies - National Register of Clinical Studies - RNEC, will be available from 5th December 2016 and will allow, at this stage, the electronic submission of the following clinical studies regarding areas regulated by Infarmed: Clinical trials with medicinal products for human use; Clinical studies with intervention of medical devices; Clinical studies with intervention of cosmetic products; Post-Authorisation Efficacy Studies (PAES) with no intervention; Post-Authorisation Safety Studies (PASS) with no intervention. read more >
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Enpr-EMA awareness webinarEuropean Medicines Agency, London, UK, From: 01-Dec-2016, To: 01-Dec-2016. This webinar aims to showcase to pharmaceutical companies the benefits of working with the European Network for Paediatric Research at EMA (Enpr-EMA) and the clinical research networks it represents in the development of medicines for children. read more >
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Ordinance no. 290-B/2016 - NATIONAL OFFICIAL JOURNAL no. 219/2016, 1st Supplement, Series I of 2016-11-15Defines the reference countries, to be considered in 2017, for the authorization of the new medicinal products prices and for purposes of annual prices revision of the hospital market and of the ambulatory market and introduces an exceptional criterion to be applied in the prices revision system and its suspension for generic medicinal products. read more >
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European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changesThis guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. read more >
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2016The European Medicines Agency´s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval at its November meeting. read more >
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Update of Chesar 3 supports use mapsECHA´s Chemical Safety Assessment and Reporting tool (Chesar) has been updated to support the use of sector-specific use maps directly in the tool. In addition, registrants can now generate their exposure scenarios for communication in a standardised ESCom XML format. read more >
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II Days of PPCIRAThe II Days of the Programme on Prevention and Control of Infection and Antimicrobial Resistance (PPCIRA) will take place in the World Antibiotic Awareness Week 2016, on the days 17th and 18th November, in the Tomé Pires Auditorium, at INFARMED. read more >
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The EDQM “Electronic submissions for CEP applications Roadmap 2016-2020” has been revised.The EDQM roadmap for electronic submissions for CEP applications has been revised in order to align with the recently established HMA (Heads of Medicines Agencies) eSubmission Roadmap. For new CEP applications, eCTD format will become mandatory as of 1 January 2018, For revisions and renewal applications eCTD format will become mandatory as of 1 January 2020. TSE only submissions and submissions for substances for veterinary use only are exempt from this ruling. read more >
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European campaign: Report side effects makes the medicines saferSee the campaign in the "Campanhas" area read more >
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Order no. 13277/2016 - NATIONAL OFFICIAL JOURNAL no. 213/2016, Series II of 2016-11-07It determines, in the scope of the National Programme for Diabetes, the development of the strategy of Access to Treatment with Devices of Continuous Subcutaneous Insulin Infusion (CSII), with the purpose of ensuring the coverage of all the population eligible in paediatric age until the year 2019. read more >
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Ordinance no. 284-A/2016 - NATIONAL OFFICIAL JOURNAL no. 212/2016, 1st Supplement, Series I of 2016-11-04It does the third amendment to Ordinance no. 224/2015, of 27th July, in the wording resulting from Ordinances nos. 417/2015, of 4th December, and 138/2016, of 13th May, and to its republishing (It establishes the legal regimen to which comply the rules of prescription and dispense of medicinal products and health products and defines the obligations of information to provide to the users). read more >
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FDA Guideline on "Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation"To assist pharmaceutical manufacturers in the development, analysis, and presentation of microbiology data during antibacterial drug development, the FDA published a guideline on "Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation". read more >
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Paediatric requirements for marketing-authorisation applicationsApplications for marketing authorisation submitted to the European Medicines Agency (EMA) that concern medicines not authorised in the European Union (EU) on 26 July 2008 must include the results of studies carried out as part of an agreed paediatric investigation plan (PIP) or information on a PIP deferral or waiver. read more >
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New features in biocides IT toolsThe biocides submission tool (R4BP 3) has been updated to support new features for Union authorisation and authorisation of same biocidal products. The tool for creating summaries of product characteristics (SPC Editor) now supports the creation of a biocidal product family with sub-families. read more >
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Annual Report of the GMP/GDP Inspectors Working Group publishedEMA´s GMP/GDP Inspectors Working Group has published the 2015 annual report summarising its activities. read more >
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Regulatory update – EMA encourages companies to submit Type I variations for 2016 by end of NovemberThe European Medicines Agency (EMA) is advising marketing authorisation holders to submit any Type IAIN and Type IA variations for 2016 by Wednesday 30 November. This will enable the Agency to acknowledge the validity of the submissions before the Agency´s closure between 23 December 2016 and 2 January 2017 within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008. read more >
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Commission launches public consultation on strengthening EU cooperation on Health Technology AssessmentLaunch of public consultation on the Commision initiative for strenghening EU cooperation on health technology assessment (HTA). read more >
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Clinical data publicationAs of October 2016, the European Medicines Agency (EMA) publishes clinical data submitted by pharmaceutical companies to support their regulatory applications for human medicines under the centralised procedure. This is based on EMA´s flagship policy on the publication of clinical data. read more >
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New ICH M9 Guideline in development on Biopharmaceutics Classification System (BCS)-based biowaiversIn October 2016, the ICH endorsed a new topic for the development of a new multidisciplinary guideline to address Biopharmaceutics Classification System (BCS)-based biowaivers. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide recommendations to support the waiver of bioequivalence studies. read more >
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Ph. Eur. Draft Chapter 3.2.1 "Glass containers for pharmaceutical use"A draft of a revised version of Ph. Eur. General Chapter 3.2.1 "Glass Containers for Pharmaceutical Use" has been published in Pharmeuropa 28.4 Comments regarding this draft can be suvmitted until 31. December 2016. read more >
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Draft Guidance Outlines Procedure for Clinical Evaluation of Software as a Medical DeviceThe draft guidance addresses stand-alone software designed to produce or extract data. read more >
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2016The European Medicines Agency´s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its October meeting. read more >
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ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population: Step 2bDraft: consultation open read more >
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FDA Adds Technical Requirements for Electronic Submission of Study DataBefore the end of the year, the FDA will begin requiring that study data for NDA, BLA, and ANDA submissions be submitted to the agency in a standardized electronic data format. read more >
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What are the GMP Responsibilities of the Marketing Authorisation Holders?The GMP/GDP Inspectors Working Group of the European Medicines Agency (EMA) has published a concept paper to summarise the GMP responsibilities of the Marketing Authorisation Holders (MAH). read more >
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Agenda - CHMP agenda of the 10-13 October 2016Draft agenda for the meeting on 10-13 October 2016 read more >
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Pre-submission checklist for 5-year renewal applicationsThe purpose of this checklist is facilitating submission of complete and correct 5-year Renewal Applications by marketing authorisation holders (MAHs). read more >
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Ordinance no. 262/2016 - NATIONAL OFFICIAL JOURNAL no. 193/2016, Series I of 2016-10-07Regulates the specific compensation given to pharmacies due to dispense of reimbursed medicinal products, according to the reduction of the reference prices. read more >
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USP announced Major Revision of General ChapterThe United States Pharmacopeia (USP) Expert Committee on General Chapters - Dosage Forms announced a major revision of general chapter Tablet Breaking Force. Comments can be submitted until October 15, 2016. read more >
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EDQM enhances sharing of information with Japanese regulatory authorities and strengthens collaboration with Japanese PharmacopoeiaThe EDQM has agreed with the Japanese authorities to improve the sharing of information related to therapeutic products that are common to both Europe and Japan, and to strengthen collaboration between the European and Japanese Pharmacopeias. read more >
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2016During its monthly meeting, the European Medicines Agency´s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) focused on the broad spectrum of its responsibilities which cover all aspects of the risk management of the use of medicines. The committee did not initiate or conclude a referral. read more >
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Dossier requirements for referral, active substance master files (ASMF) and nationally authorised products (NAPs) submissions (PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical deviceUpdate read more >
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New MEDDEV Document on the Clinical Evaluation of Medical DevicesTo put EU Medical Devices (93/42/EEC and 90/385/EEC) in concrete terms, the EU issues so-called MEDDEV documents. In this context, the document MEDDEV 2.7/1 revision 4 entitled "Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEV" has been newly published. read more >
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Ordinance no. 256/2016 - NATIONAL OFFICIAL JOURNAL no. 187/2016, Series I of 2016-09-28Approves the principles and standards of good distribution practice of medical devices (listed in the annex) to be considered by the entities that exercise the activity of medical device wholesale distribution read more >
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Ordinance no. 255/2016 - NATIONAL OFFICIAL JOURNAL no. 186/2016, Series I of 2016-09-27Amends the Ordinance no. 223/2015, of July 27 [Regulates the procedure of payment of the State reimbursement in the retail selling price (PVP) of the medicinal products made available to beneficiaries of the National Health Service (NHS) and of public subsystems that are the NHS responsibility, or that benefit from reimbursement in regime of complementary]. read more >
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Joint Newsletter no. 8/2016/ACSS/INFARMED/SPMS – update of health care goods and services that should be object of centralised acquisitionPlease find the joint newsletter attached. read more >
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FDA Reviews Questions on ICH Guidance for Nonclinical Evaluation of Cancer DrugsThe FDA is taking public questions and comments relating to implementing a global guidance from 2010 on the nonclinical evaluation of anticancer drugs, also known as the S9 guidance, developed by the International Council for Harmonisation. read more >
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PRIME: priority medicinesPRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. read more >
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Task force for the implementation of International Standards on Identification of medicinal products in the EU (i.e. EU ISO IDMP task force)Update read more >
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GVP UpdateEudralex Volume 9 - Guideline on good pharmacovigilance practices (GVP) now comprises several updates. read more >
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Inception Impact Assessment on Strengthening of the EU cooperation on Health Technology Assessment (HTA)
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September Newsletter gives practical advice to registrantsThis issue includes useful advice to companies who are preparing their submissions for the REACH 2018 registration deadline and explains how ECHA checks the completeness of registration dossiers. We also look back on the past three years of the Biocidal Products Regulation and give an update on where we are today. In addition, you can read interviews with experts on substitution, socio-economic analysis and the circular economy. read more >
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Progress made in the operation of EU pharmacovigilance legislationThe European Medicines Agency (EMA) is organising the tenth stakeholder forum on the operation of the pharmacovigilance legislation on 21 September 2016. This is the latest in a series of events organised by EMA to review the progress made and to consult stakeholders on what needs to be the focus over the coming years. read more >
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Analytical Lifecycle: USP "Statistical Tools", Analytical Target Profile and Analytical Control StrategyThe United States Pharmacopeia (USP) is currently undertaking further steps towards a comprehensive analytical lifecycle approach by publishing a draft of a new General Chapter Statistical Tools for Procedure Validation and two Stimuli Articles regarding Analytical Target Profile and Analytical Control Strategy in Pharmacopeial Forum. read more >
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Application form for the involvement of industry stakeholder organisations in the activities of the European Medicines Agency (EMA)Further to the adoption of the Framework for interaction between the European Medicines Agency and industry stakeholders in October 2015, this application form has been created of the Agency to evaluate whether a specific industry stakeholder organisation fulfils the elegibility criteria for involvement in the Agency´s activities. read more >
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Decree-Law no. 62/2016 - NATIONAL OFFICIAL JOURNAL no. 175/2016, Series I of 2016-09-12It establishes the terms and conditions of the provision of intervention services in public health by the community pharmacies, as well as the possibility of awarding a specific compensation to the pharmacies due to dispense of reimbursed medicinal products, namely in the medicinal products inserted in homogeneous groups. read more >
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Advertise your medicinesHow to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines. read more >
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Fighting antimicrobial resistance globallyAlignment of data requirements by regulators worldwide can contribute to stimulate the development of new antibiotics to fight antimicrobial resistance and protect global public health. read more >
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Signal detection and management information dayThis information day will review signal detection and management activities essential to the overall risk management process of a medicinal product. read more >
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Highlights from the European Medicines Agency industry platform meeting held on 21 April 2016 on the operation of the centralised procedure for human medicinal productsThe purpose of these platform meetings between regulators and representatives of industry stakeholder organisations is to provide an opportunity for both general updates and more focused discussions on specific processes or issues to support continuous improvement, and generally to foster a constructive dialogue with industry stakeholders. read more >
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Communication of Notified Prices through GAMWith the purpose of facilitating the
process of communication of notified prices, the Management of Accessibility to
Medicinal Product (GAM) application was updated with a new module, available
from 01/09/2016 – GAM – Module 10 – Regimen of Notified Prices.
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EMA - requirements for quality documentation concerning biological investigational medicinal productsThe European Medicines Agency published a draft “Guideline on the
requirements for quality documentation concerning biological
investigational medicinal products in clinical trials”.
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USP revised about thirty Ophthalmic Ointment MonographsOn July 29, 2016, the
United States Pharmacopeia (USP) posted a new Revision Bulletin regarding
approximately thirty Ophthalmic Ointment Monographs.The revised monographs
became official on August 1, 2016.
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FDA Asks Manufacturers of Syringe Pumps to Revise Labels, WarningsManufacturers of syringe pumps are being asked to update their labels to address flow continuity concerns that the FDA has identified as a serious risk to health.
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Minutes of the PRAC meeting 06-09 June 2016Pharmacovigilance Risk Assessment Committee (PRAC)
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Implementation of ICH Q3D within the CEP ProcedureThe EDQM has implemented the requirements of the ICH
Q3D Guideline on elemental impurities also for the CEP procedure and
has published a new policy document. Read more here about what
has to be considered when applying or renewing a CEP, or for already
existing CEPs with regard to elemental impurities in APIs.
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REACH 2018: Assess your substance to show safe useCompanies registering the same substance must work together to compile
and share information on the uses, hazards and risks of their substance
to demonstrate safe use. If new data involving animal testing needs to
be generated, alternatives must always be considered first. All
information should be reported in a registration dossier and submitted
to ECHA by 31 May 2018.
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Send and receive information on adverse drug reactions (ADRs)How marketing authorisation holders should inform MHRA of an ADR to a medicine, using the E2B messaging system.
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Signal managementDesignated medical events (update). EMA has developed a list of designated medical events containing medical conditions that are inherently serious and often medicine-related. It does not address product specific issues or medical conditions with high prevalence in the general population. The list contains Medical Dictionary for Regulatory Activities (meDRA) terms and serves as a safety net in signal detection. read more >
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Is AQL Testing required within the 100% Visual Inspection?One of the most frequently asked questions is whether an additional testing based on samples is required after the 100% visual inspections of parenterals. The answer is: basically, "yes". read more >
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Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations II: Biological medicinal products with tracked changesTrack-change version
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Data integrity: key to public health protectionThe European Medicines Agency (EMA) has released new good manufacturing practice (GMP) guidance to ensure the integrity of data that are generated in the process of testing, manufacturing, packaging, distribution and monitoring of medicines. Regulators rely on these data to evaluate the quality, safety and efficacy of medicines and to monitor their benfit-risk profile throughout their life span. Controlling of data records helps ensure that the data generated are accurate and consistent to support good decision-making by both pharmaceutical manufacturers and regulatory authorities. read more >
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EMA publishes Q&A Document on Production of WFI not obtained by DistillationThe revision of chapter 0169 of the European Pharmacopoeia will introduce in Europe as of April 2017 the possibility to produce WFI using other techniques than distillation. However, many questions are still unanswered like for example how the robustness of the new procedure compared to distillation should be demonstrated. The now published paper has been therefore highly antecipated. read more >
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Human medicines highlights - July 2016The newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency. read more >
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Send and receive information on adverse drug reactions (ADRs)How marketing authorisation holders should inform MHRA of an ADR to a medicine, using the E2B messaging system. read more >
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What does Brexit mean for the QP?The decision of the U.K. to leave the EU has caused a high uncertainty throuhgout industry - and also in the pharmaceutical industry. The European QP Association has received a number of questions on what Brexit actually means for QPs. For that reason the EQPA leadership team has prepared some information. read more >
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PRAC recommendations on signals adopted at the PRAC meeting of 4-8 July 2016Adopted read more >
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WHO Technical Report - GMP for Biological Products adoptedAs a part of their Technical Report Series with guidance documents comprising recommendations for biological products, the The World Health Organization (WHO) now published "Annex 2 - WHO good manufacturing practices for biological products". read more >
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Annual report of the Pharmacovigilance Inspectors Working Group for 2015This document is the eighth annual report of the Pharmacovigilance Inspectors Working Group (PhV IWG). The PhV IWG has been established by the European Medicines Agency (hereinafter "the Agency") within the scope of Article 57(1)(i) of Regulation (EC) No. 726/2004. read more >
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Revision of application forms “Request for new Certificate of Suitability” and “Request for revision or renewal of Certificate of Suitability”The application forms for the submission of new CEP applications and for requests for revision/renewal have been slightly revised. read more >
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WHO Draft on Analytical Method ValidationThe World Health organization (WHO) recently published a draft document on analytical method Validation for comment. read more >
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Good pharmacovigilance practice (GPvP)Comply with good pharmacovigilance pratice, complete a compliance report and prepare for an inspection. read more >
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EMA recommends suspension of medicines over flawed studies at Semler Research CentreThe European Medicines Agency (EMA) has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd., Bangalore, India. The Agency has also recommended that medicines currently being evaluated for aulthorisation and which rely only on bioequivalence studies from this site should not be authorised until bioequivalence is demonstrated using alternative data. read more >
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MHRA GxP Data Integrity Definitions and Guidance for IndustryMHRA has produced draft GxP data integrity guidance for industry and they welcome your comments. read more >
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Elaboration of New USP General Chapter - Analytical Procedure Lifecycle - announcedOn June 24, 2016, the USP announced the elaboration of a new general chapter regarding life cycle management of analytical methods. read more >
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Agenda - CHMP agenda of the 18-21 July 2016 meetingCHMP agenda of the 18-21 July 2016 meeting
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System of Reference Prices – Amendment of new homogeneous groupsThe list of Homogeneous Groups and of unit reference process to be in force in the 3rd trimester of 2016 will be updated with the inclusion of 4 new homogeneous groups, for which the reference price was approved (GH1078, GH1079, GH1080 and GH1081) - diclofenac + misoprostol, modified-release tablet, 75 mg + 0,2 mg and omeprazole, gastro-resistant capsule, 10 mg. read more >
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Health claims guidance update – have your say on revised scientific and technical requirementsEFSA has launched a public consultation on its revised scientific and technical guidance for the preparation and presentation of a health claim application. Interested parties have until 12 September 2016 to submit comments on the draft document. read more >
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ICH M4E(R2) Guideline reaches Step 4 of the ICH ProcessThe revised version of the ICH M4E(R1) Guideline on Enhancing the Format and Structure of Benefit-Risk Information in ICH reached Step 4 of the ICH Process in June 2016 and now enters the implementation period (Step 5). read more >
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Example by Inspectorate for Handling Temperature ExcursionsIn a recent blog, the MHRA is illustrating its opinion with an example of a short-term temperature excursion during the transport of a product from a third country to the EU. read more >
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ICH E17 Guideline reaches Step 2b of the ICH ProcessThe ICH E17 Guideline on Multi-Regional Clinical Trials reaches Step 2b of the ICH Process in June 2016 and now enters the consultation period (Step 3). This new ICH Guideline is proposed to provide guidance on general principles on planning/designing Multi-Regional Clinical Trial (MRCT). read more >
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EU Aims For U.S., EU Regulatory Harmonization on Approval, Guidelines and GMPThe European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance. read more >
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Questions and answers: Article 29(4) referral proceduresThis page lists questions that stakeholders, particulary marketing authorisation holders (MAHs)/applicants, may have on Article 29(4) referral procedures. read more >
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WHO publishes Draft of an Umbrella Guideline on Process ValidationAt the end of 2015, the WHO adapted its Appendix 7 to the latest technological standards. Appendix 7 provides support with regard to non-sterile process validation. Now, further changes to WHO guidelines are in sight. One of these changes concerns the guideline on process validation which is currently available as a draft and can be commented on until July, 12th 2016. read more >
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PRAC recommendations on signals adopted at the PRAC meeting of 6-9 June 2016This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 6-9 June 2016 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT] reference numbers). read more >
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Annex 16: How a QP should handle unexpected DeviationsIn a recent blog of MHRA, the inspectorate looks at one aspect of the new Annex 16 - the handling of unexpected deviations. read more >
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Medicines and Healthcare products Regulatory Agency statement on the outcome of the EU referendumThe Agency´s response to the outcome of the EU referendum. read more >
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EMA public workshop on extrapolation of efficacy and safety in medicine developmentUpdate - European Medicines Agency, London, UK, From: 17-May-2016, To: 18-May-2016
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Variations and Revocations of Medicinal Products PricesNewsletter no. 096/CD/8.1.6 - Regimen of Notified Prices.
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European Union (EU) workshop on ICH Q3D from a quality perspectiveUpdate: European Medicines Agency, London, UK, From: 05-Apr-2016, To: 06-Apr-2016
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Current Issues of GDP OversightSince the publication of the EU GDP Guideline in March 2013 various measures for GDP oversight have been taken. While comprehensive measures exist in the area regulated by the EU GDP guidelines, there still are areas where oversight is insufficient or where diverse interpretations raise questions and issues.
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System of Reference Prices – 3rd Trimester of 2016The list of Homogeneous Groups and the unit reference prices to be force in the 3rd trimester of 2016 was approved by delibaration no. 53/CD/2016, of 9 June 2016, of the Board of Directors, and enters into force on 1 July 2016
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FDA releases new internal policy on ICH Q8, Q9, Q10 GuidelinesOn May 18, 2016, the US Food and Drug Administration (FDA) released a new policy document on applying ICH Q8, Q9, and Q10 principles to chemistry, manufacturing, and controls review. read more >
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Revision of the general Chapter on Pharmaceutical Water in the US PharmacopoeiaThe 2nd supplement of USP39 NF34 comprises the revised version of the chapter on pharmaceutical water of the US Pharmacopeia Water for pharmaceutical purposes. read more >
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Periodic safety update reportsThis page includes information on periodic safety update reports (PSURs), European Union (EU) reference dates for medicines and the frequency of submission of PSURs. read more >
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Leaflet - eHealth: connecting health systems in EuropeLeaflet - eHealth: connecting health systems in Europe.
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TTIP: The End of FDA Inspections in Europe?Would the implementation of TTIP bring an end to FDA inspections in the EU? This is discussed in the EU proposal for a respective annex on medicinal products. read more >
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Requirements on submissions (number and format) for Variations and Renewals within MRP and National proceduresUpdate read more >
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Regulation of advanced therapy medicinesThe European Medicines Agency (EMA) published a report from a multi-stakeholder expert meeting held on 27 May 2016 to explore possible ways to foster the development of ATMPs in Europe and expand patients acess to these new treatments. read more >
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European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changesUpdate read more >
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Regulatory information – A new operating model for procedure management to improve support for evaluation proceduresThe Agency is introducing a new operating model for the management of evaluation procedures. With the new model procedure managers and procedure assistants will be allocated per product, rather than per procedure, in order to improve the co-ordination of regulatory activities with a product, particularly where multiple regulatory procedures are run in parallel for same product. The strong procedural focus that has already been archieved with the current model will be maintained and strengthened throught the creation of process-focused communities that comprise EMA staff specialising in specific procedures. read more >
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Newsletter no. 082/CD/100.20.200. – 30/05/2016 – Communications Platform – Transparency and PublicityThe Communications Platform - Transparency and Publicity was updated in order to facilitate its use, as well as bearing in mind its inclusion in the NHS Portal. read more >
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Ordinance no. 154/2016 - NATIONAL OFFICIAL JOURNAL NO. 102/2016, Series I of 2016-05-27Regulates the regimen of prices notified of the medicinal products subject to medical prescription not reimbursed or non-reimbursable, in the terms of Ordinance no. 195-C/2015, of 30 June. read more >
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WHO issues revised Guideline on HVAC SystemsThe World Health Organization (WHO) recently issued a guideline for commenting which describes the requirements for HVAC systems for the manufacture of non-sterile forms. As most guidelines on this address on this topic address the requirements for sterile dosage forms, the previous version was gladly accepted by industry. read more >
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EMA post-authorisation procedural advice for users of the centralised procedureThe European Medicines Agency (EMA) recently published an updated Questions and Answers paper on post-authorisation procedural advice for users of the centralised procedure. read more >
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Accessing key EMA information on human medicinesA guide, released last week by the European Medicines Agency (EMA), describes information the Agency publishes on centrally and non-centrally authorised medicines for human use. read more >
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INFARMED SIMPLEX: Licensing of pharmacies and saving in medicinal products will be simpler.The licensing of pharmacies will be a simplex process, totally performed in an electronic portal associated to the website INFARMED, I.P.. This will be on of the nine ambitious SIMPLEX + measures allocated to the medicinal product regulator, which will benefit more than thousand addressees, between pharmacies, companies and entrepreneurs. The 255 Simplex measures were public announced yesterday. read more >
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Progress in science, medicine and healthThe European Medicines Agency´s (EMA) 2015 annual report published today focuses on the Agency´s core tasks which include the evaluation of medicines, support to research and development of new and innovative treatments and the monitoring of the benefits and risks of medicines in real life. read more >
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Press Release – Infarmed reassesses the reimbursement of 115 more expensive medicinal productsINFARMED, I.P. is reassessing the reimbursement of the non-generic (brand) medicinal products that have a price 20% higher than therapeutic alternatives used with the same purpose and also non-generic. This reassessment may imply the non-reimbursement of these medicinal products, unless the laboratories making them available adjust the prices down to this limit. read more >
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CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised Procedures (May 2016)The objective for this Best Practice Guide (BPG) is to emphasise the importance of taking care in the compilation of the dossier for a Marketing Authorisation Application (MAA), to minimise delays in validation, to avoid invalidation of submissions, to forestall questions from Member States (both RMS and CMS), and to enhance the efficiency of the regulatory process.
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Draft reflection paper on the dissolution specification for generic oral immediate release productsDraft: consultation open read more >
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Can regulators influence the affordability of medicines?The growing problem of high medicine prices and its impact on the sustainability of health care systems is getting more and more attention in many countries around the globe. Regulators are willing to play their part in solving the problem and in facilitating continued access of patients to safe and effective medicines. In an article published yesterday in the New England Journal of Medicine (NEJM) two representatives of the European Medicines Agency (EMA), i.e. its Executive Director and Senior Medical Officer, as well as Heads of two national agencies discuss possible regulatory interventions. read more >
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NTA update of volume 6AVolume 6 of the publications "The rules governing medicinal products in the European Union" contains a list of regulatory guidelines related to procedural and regulatory requirements such as renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of product characteristics (SPC), package information and classification for the supply, readability of the label and package leaflet requirements. read more >
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USP publishes draft of a new general chapter <661.3> for plastic components used in manufacturingIn the Pharmacopoeial Forum (PF) 42(3) (May-June 2016) the USP General Chapters - Packaging and Distribution Expert Committee proposes a new chapter to address the qualification of plastic components used in the manufacture of APIs (pharmaceutical and biopharmaceutical) and drug products (DPs). The proposed Title of the new chapter <661.3> is Plastic Components and Systems Used in Pharmaceutical Manufacturing. read more >
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Deliberation no. 797/2016 - NATIONAL OFFICIAL JOURNAL NO. 89/2016, Series II of 2016-05-09Extinction of the Unit of Information Mangement; creation of the Unit of Management of the Medicinal Product and Medical Devices Account read more >
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Decide if your product is a medicine or a medical deviceHow the Medicines and Healthcare products Regulatory Agency (MHRA) makes decisions on what is a medicine or medical device (borderline products). read more >
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Excipients labellingThe European Medicines Agency (EMA) published background documents on excipients for inclusion in the label and package leaflet of human medicines. read more >
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EMA publishes finalised Process Validation Guideline for Biotech ProductsApproximately two years ago the EMA published a draft guideline on process validation for the manufacture of biotech products. Now the final guideline has been published under the title "Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission." read more >
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Training course on Variations – Filling Variations (23-24/05/2016)The
increasing growth of the volume and complexity of the regulatory requirements
related to the Filling and Submission of Variations has been a constant in the
life of all the Regulatory Affairs professionals and of many other
professionals. Having
identified this gap in the panorama of services provided in Portugal, Phagecon
will organise, on the days 23 and 24 May in Lisbon, the training “Filling
Variations”. This
training will be given by Andrew Willis, a professional with 30 years of
experience in some of the biggest companies of the world and that gives the
same training in the reputable PTI (Pharmaceutical Training International), Take
advantage of the last seats available of this excellent opportunity. Come enjoy
top training in the entire World.
To do so
just click on the link below and fill the applicable form and send the proof of
payment with identification of the company and trainee to the email – training@phagecon.pt
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Article 58 applications: Regulatory and procedural guidanceArticle 58 of Regulation (EC) No 726/2004 allows the Agency´s Committee for Medicinal Products for Human Use (CHMP) to give opinions, in co-operation with the World Health Organization (WHO), on medicinal products for human use that are intended exclusively for markets outside of the European Union (EU). read more >
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Integrating patients’ views in clinical studies of anticancer medicinesThe European Medicines Agency (EMA) has published new guidance on the use of patient-reported outcome (PRO) measures in oncology studies. The new guidance is an appendix to the guideline on the evaluation of anticancer medicinal products in man, which was last revised in July 2013. read more >
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Quality of medicines questions and answers: Part 1These questions and answers address a number of questions that have been brought to the attention ot the Joint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working party (QWP) by marketing-authorisation holders (MAHs) or European Economic Area (EEA) competent authorities, on matters related to the quality of medicines. They have developed and are maintained by the QWP. read more >
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Draft concept paper on an addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev. 2) to address paediatric-specific clinical data requirementsDraft: consultation open read more >
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GMP/GDP: When will I be inspected by the AuthoritieVarious competent authorities are performing inspections. But who is subject to such an inspection? read more >
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Good laboratory practice (GLP) for safety tests on chemicalsAs a test facility, comply with regulatory requirements for carrying out product safety tests for human health, animal health or the environment. read more >
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Briefing note to marketing authorisation holders/applicants on the European Medicines Agency Patient Registry InitiativeThrough the Patient Registry Initiative launched in September 2015, the EMA aims to facilitate
interactions between registry co-ordinators and potential users of registry data both at an early stage
of the development, during the marketing authorisation evaluation procedure and post-authorisation.
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Update of the list of medicinal products subject to previous notification of exportation or distribution to other member-statesDeliberation no. 661/2016, of 26 March, updates the list of
medicinal products whose consumptions, exportation of distribution to other
Member-States of the European Union depend on the notification to Infarmed.
This list enters into force on the 5th day after being published, i.e., on 20th
April.
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Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary containerDraft: consultation open
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Deliberation no. 662/2016 - National Official Journal no. 72/2016, Series II of 2016-04-13Regulation of functioning of the Evaluation Committee of the Health Technologies - CATS read more >
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Methodological guidelines and recommendations for efficient and rational governance of patient registries
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Implementation of the ISO IDMP standardsThe European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for StandardizationExternal link icon (ISO) for the identification of medicinal products (IDMP). These are a set of common global standards for data elements, formats and terminologies for the unique identification of and the exchange of information on medicines. Following a phased implementation process, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these formats and terminologies. read more >
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List of European Union reference dates and frequency of submission of periodic safety update reports
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The new Annex 16 is coming into ForceThe new Annex 16 "Certification by a Qualified Person and Batch Release" will become effective as of 15 April 2016. The contents will reflect the coming state of expectations regarding the batch release. read more >
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Orphan designationThis section provides guidance and procedural information on applying for orphan designation for medicines for rare diseases in the European Union (EU). It also includes information on what happens after a designation has been granted, including the incentives available for sponsors developing orphan medicines. read more >
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Fees payable to the European Medicines AgencyThe European Medicines Agency charges fees for the services it provides. The rules relating to the Agency's fees are governed by the fee Regulation (Council Regulation (EC) No 297/95) and its implementing rules, as well as the pharmacovigilance fee Regulation (Regulation (EU) No 658/2014). read more >
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Parallel scientific advice from regulators and health-technology-assessment bodiesThe European Medicines Agency (EMA) offers scientific advice and protocol assistance in parallel with health-technology-assessment (HTA) bodies. This procedure aims to allow medicine developers to gain feedback from regulators and HTA bodies at the same time, at any point in the developmental lifecycle of medicines. This helps them to establish the evidence that both parties will need to determine a medicine's benefit-risk balance and value as efficiently as possible. read more >
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QP Education and Qualification - What is needed?We are frequently asked about the educational requirements in order to become a Qualified Person in Europe. Comprehensive educational modules are offered, especially in the UK. These training courses contain different topics like pharmaceutical law, Microbiology, Quality Management etc and require the trainee to take part in multiple courses over an extended period. But is this needed to become a QP in Europe? read more >
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TRAINING COURSE ON GENERICS MASTERING REGULATORY AND DEVELOPMENT STRATEGIES FOR GENERICS (18-19/04/2016)The growing increase of the volume and complexity of the regulatory requirements regarding Generic Medicinal Products has been a constant in the life of all the Regulatory Affairs professionals. Having identified this gap in the panorama of services provided in Portugal, Phagecon will organise, on the days 18 and 19 April in Lisbon, the training Training course on Generics Mastering Regulatory and Development Strategies for Generics. This training will be given by Andrew Willis, a professional with 30 years of experience in some of the biggest companies of the world and that gives the same training in the reputable PTI (Pharmaceutical Training International). Take advantage of the last seats available in this excellent opportunity. Come enjoy top training in the entire World. To do so just click on the link (http://www.phagecon.pt/files/Training_Course_on_Generics.pdf) and fill the applicable form and send the proof of payment with identification of the company and trainee to the email training@phagecon.pt read more >
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Reflection paper on assessment of cardiovascular safety profile of medicinal productsAdopted read more >
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EMA publishes GVP Module V (Revision 2) for public commentModule V of the Guideline on Good Pharmacovigilance Practice (GVP) has been revised by the European Medicines Agency (EMA). Deadline for Comments is May 31, 2016. Module V covers the topic "Risk Management". read more >
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Ordinance no. 48/2016 National Official Journal no. 57/2016, Series I of 2016-03-22Determines that the medicinal products meant for the treatment of patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis and plaque psoriasis benefit from an exceptional reimbursement regimen. read more >
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 March 2016In March, the Pharmacovigilance Risk Assessment Committee (PRAC) concluded one safety review. It also discussed three new safety reviews. For one of these, regarding the cancer medicine Zydelig, the PRAC proposed provisional measures, as a precaution, to protect patients while the medicine is being reviewed. read more >
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Post-orphan medicinal product designation procedures: guidance for sponsorsThe opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the European Medicines Agency (EMA). read more >
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European Medicines Agency/International Federation for Animal Health Europe info day 2016European Medicines Agency, London, UK, From: 17-Mar-2016, To: 18-Mar-2016. The info day covers the latest developments in the scientific review, regulation and marketing authorisation procedure. It is an opportunity for professionals to get first-hand information on current developments in the veterinary regulatory scene. Registration open. read more >
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Already 13 EMA GMP Non-compliance Reports in 2016 publishedEudraGMDP is the central database for GMP and GDP compliance. Inspections which have been performed by any of the EU member state inspectorates are published in the database. read more >
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Update of the Platform of Management of Accessibility of the Medicinal ProductThe ruptures of existences, even though merely transient, of manufacturing or supply of a medicinal product, as well as any disturbance to the normal supply of the market, are a concern of this Authority, being part of its mission to ensure the access of the healthcare professionals and of the citizens to quality, effective and safe medicinal products. read more >
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FDA Guideline on Dissolution TestingThe FDA has presented the draft of a revised guideline on dissolution testing for immediate release. Under certain conditions, the tests can now be standardised. read more >
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PRIME: priority medicinesPRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. read more >
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Runoff deadlines elapsing from the application of the Annual Prices RevisionAs disclosed in Newsletter no. 193/CD/8.1.6., of 25/11/2015, the runoff deadline, in the pharmacies, of the packages with the maximum prices previous to those resulting from the annual prices revision of non-generic medicinal products is as follows: 60 working days, counting from 01-01-2016 (up to 28-03-2016). read more >
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Guidance for the publication of clinical dataThe European Medicines Agency (EMA) has published detailed guidance for pharmaceutical companies on the requirements to comply with its policy on the publication of clinical data. read more >
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ICH guideline S1 - Regulatory notice on changes to core guideline on rodent carcinogenicity testing of pharmaceuticalsAdopted read more >
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Ordinance no. 3206/2016 - National Official Journal no. 43/2016, Series II of 2016-03-02Establishes dispositions about the reference process of people with reactive tests or infected by the viruses of hepatitis B and C, or with other sexually transmitted infections, coming from services and establishments of the National Health Service (NHS) or from entities that have celebrated agreements with the NHS for the providing of health. read more >
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Ordinance no. 35/2016 - National Official Journal no. 42/2016, Series I of 2016-03-01Establishes the State reimbursement regimen in the maximum price of the reagents (test strips) for determination of blood glucose, ketonemia and ketonuria and of the needles, syringes, lancets and other medicinal devices for the purpose of self-monitoring of people with diabetes, to beneficiaries of the National Health Services and revokes Ordinance no. 222/2014, of 4 November. read more >
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Government and operators of the medicinal product circuit sign CommitmentThe Ministry of Health and the associations representative of the pharmaceutical industry and medical devices, the wholesale distributors and the pharmacies signed a Commitment for the Sustainability and the Development of the National Health Service (NHS) based on four strategical principles: access, innovation and sustainability; rational use of the medicinal product and health products; market supervision; and investigation, development and competitiveness. The agreement negotiated along the last months was signed on 26th February, in a ceremony that had the presence of the President of the Bar of the Portuguese Pharmacists Association. read more >
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Order No. 2935-B/2016 - National Official Journal No. 39/2016, 1st Supplement, Series II of 25-02-2016Establishes provisions in order to enhance the generalisation of the dematerialised electronic prescription (Paperless Prescription), in the National Health Service, creating specific targets for its realization read more >
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Recall of medicinal products manufactured by Farma Mediterrània, S.L.After the inspection performed by the Spanish Agency to the manufacturer Farma Mediterrània, S.L. (Spain), critical and major non-conformities to the Good Manufacturing Practices have been detected. read more >
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ICH publishes Training Modules on "ICH Q3D - Elemental Impurities"The ICH has recently published 7 training modules on the ICH Q3D Guideline "Elemental Impurities". read more >
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Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human useCertain aspects of the implementation of the Falsified Medicines Directive (Directive 2011/62/EU) and the new delegated act on the safety features (Commission Delegated Regulation (EU) 2016/161 - "the Delegated Regulation") may impact on the product information and the marketing authorisation dossier; in particular the placing of safety features, a unique identifier (UI) carried by a 2-D barcode and an anti-tampering device (ATD), on the packaging of prescription medicines and certain nonprescription medicines for the purposes of authentication and identification. read more >
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Sistema de Preços de Referência - Aditamento de novos grupos homogéneosA lista dos Grupos Homogéneos e dos preços de referência unitários a vigorar no 1.º trimestre de 2016 será atualizada com a inclusão de 2 novos grupos homogéneos, para os quais foi aprovado o respetivo preço de referência (GH1070 e GH1071) da substância ativa Rasagilina de 1 mg. read more >
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Requirements on submissions (number and format) for New MA Applications and Variations and Renewals within MRP, DCP or National procedures
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Progress report of the UK reclassification platformPublication of the first years work of the UK stakeholders' reclassification platform. read more >
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Project Via Verde do Medicamento (Fast Access to the Medicinal Product)INFARMED, I.P. celebrated on 17th July 2015, a collaboration protocol with the professional associations of the sector of the medicinal product (APIFARMA, ANF, GROQUIFAR and AFP), with the name Project Via Verde do Medicamento (Fast Access to the Medicinal Product), which has been taking place in pilot stage in the district of Coimbra. Due to the results obtained in the pilot stage, the Project Via Verde do Medicamento (Fast Access to the Medicinal Product) will spread to all the mainland, from 15th February 2016. read more >
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Standard operating procedure for eligibility to the centralised procedure for medicinal products for human use
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Falsified medicinesFalsified medicines are fake medicines that pass themselves off as real, authorised medicines. The European Union (EU) has a strong legal framework for the licensing, manufacturing and distribution of medicines, centred around the Directive on falsified medicines for human use, so that only licensed pharmacies and approved retailers are allowed to offer medicines for sale, including legitimate sale via the internet. The European Medicines Agency is working closely with its partners on the implementation of these laws. read more >
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List of Union reference dates and frequency of submission of periodic safety update reports (PSURs)
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The GMP year 2015 - what was new in the EU?The previous year 2015 was another eventful year. Again there were new developments in the GMP environment as well as announcements of changes that preoccupied the pharmaceutical industry. read more >
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The World Health Organisation declares the Zika virus outbreak a Public Health Emergency of International Concern
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Dossier requirements for submission of marketing authorisation and maximum-residue-limit applications to the European Medcines Agency and to members o
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DESPACHO N.º 1571-B/2016 - DIÁRIO DA REPÚBLICA N.º 21/2016, 1º SUPLEMENTO, SÉRIE II DE 2016-02-01Determina que é obrigatória a centralização da aquisição de bens e serviços específicos da área da saúde, para todos os serviços e instituições do Serviço Nacional de Saúde (SNS) e órgãos e serviços do Ministério da Saúde, sendo esta assegurada pela SPMS - Serviços Partilhados do Ministério da Saúde, E. P. E. read more >
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Qualification of novel methodologies for medicine developmentThe European Medicines Agency offers scientific advice to support the qualification of innovative development methods for a specific intended use in the context of research and development into pharmaceuticals. read more >
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DGAV presta esclarecimentos sobre o suplemento alimentar 'CALCITRIN MD'Na sequência das notícias vindas a público sobre o suplemento alimentar 'Calcitrin MD', a Direção Geral de Alimentação e Veterinária (DGAV), enquanto Autoridade Competente em matéria de suplementos alimentares, esclarece o enquadramento legal do CALCITRIN e dos suplementos alimentares no geral. read more >
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Increasing access to reports on adverse reactions to medicinesThe European Medicines Agency (EMA) will give increased access to reports on suspected adverse reactions to medicines authorised in the European Union (EU), while guaranteeing that personal data will be fully protected. This is the outcome of a revision of EudraVigilance Access policy, which was adopted by EMAs Management Board at its December 2015 meeting. The adoption followed a broad public consultation generating close to 400 comments which have been taken into account in the final policy. read more >
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Canadian Food Inspection Agency and EFSA enhance cooperation in risk assessmentEFSA and the Canadian Food Inspection Agency (CFIA) have agreed to enhance their scientific cooperation and dialogue related to risk assessment. Martine Dubuc, Vice-President of Science and Chief Food Safety Officer of CFIA, and Bernhard Url, Executive Director of EFSA, signed a Memorandum of Cooperation on 14 December 2015 for an initial period of five years. read more >
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European Medicines Agency public workshop on extrapolation of efficacy and safety in medicine developmentEuropean Medicines Agency, London, UK, From: 17-May-2016, To: 18-May-2016. The European Medicines Agency (EMA) published in 2013 the concept paper on extrapolation of efficacy and safety in medicine development. Its aim is to discuss the need and possibility to develop a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation. The framework shall set out a structured approach to be followed for each extrapolation exercise to improve interactions with stakeholders and to standardise decision making across committees. Further to the extrapolation expert meeting that took place in September 2015, EMA will publish a reflection paper on extrapolation across age groups that will include considerations specific to global product development and licensing of paediatric medicines. EMA will host an open workshop on 17-18 May 2016, with a view to present the reflection paper and seek feedback from developers. read more >
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Applications for new human medicines under evaluation by the CHMP: December 2015This document lists information on applications for centralised marketing authorisation for human medicines that the European Medicines Agency has received for evaluation. It includes the international non-proprietary names (INN) and therapeutic areas for all new innovative medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP). For generic and biosimilar medicines, it includes the INN (active moiety only, with no information on salt, ester or derivative) and therapeutic area. read more >
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EMA ready to address challenges aheadSupport to innovative medicines, transparency and patient involvement will be among the priorities of new EMA Executive Director Guido Rasi read more >
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PREFOR - Portal de Registo de Fornecedores do INFARMED, I.P.O Portal PREFOR conduzirá à constituição de um repositório de informação dos fornecedores do INFARMED, I.P. permitindo agilizar os procedimentos de aquisição por ajuste direto, essencialmente no que respeita à fase de seleção dos fornecedores. read more >
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PORTARIA N.º 417/2015 - DIÁRIO DA REPÚBLICA N.º 238/2015, SÉRIE I DE 2015-12-04Primeira alteração à Portaria n.º 223/2015, de 27 de julho, que regula o procedimento de pagamento da comparticipação do Estado no preço de venda ao público (PVP) dos medicamentos dispensados a beneficiários do Serviço Nacional de Saúde (SNS) e à Portaria n.º 224/2015, de 27 de julho, que estabelece o regime jurídico a que obedecem as regras de prescrição e dispensa de medicamentos e produtos de saúde e define as obrigações de informação a prestar aos utentes read more >
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The QP Declaration: some Questions remain openMore than one year after the final guidance on the QP Declaration was published, some questions remain open or are frequently asked by the stakeholders. The most important ones have been summarised in a CMDh document. read more >
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Good-clinical-practice complianceGood clinical practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that clinical-trial data are credible. read more >
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Good practice guide on risk minimisation and prevention of medication errorsThe European Medicines Agency (EMA) in collaboration with the EU regulatory network was mandated to develop regulatory guidance for medication errors, taking into account the recommendations of a stakeholder workshop held in London in 2013. read more >
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FAQ: foods for special medical purposesEFSA has published scientific and technical guidance that will help the European Commission to apply new rules on foods for special medical purposes (FSMPs). But what are these products and how will the new rules work? Our nutrition specialists answer the key questions. read more >
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Revisão anual de preços dos medicamentos não genéricosMercado Ambulatório e Hospitalar - 2016 read more >
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Post-orphan medicinal product designation procedures: guidance for sponsorsThe opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the European Medicines Agency (EMA). read more >
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Medicinal products for human use: monthly figures - October 2015This document provides current information related to the volume and evaluation of marketing authorisation and post-authorisation applications for medicinal products for human use received by the European Medicines Agency. read more >
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PORTARIA N.º 406/2015 - DIÁRIO DA REPÚBLICA N.º 229/2015, SÉRIE I DE 2015-11-23Primeira alteração à Portaria n.º 55/2013, de 7 de fevereiro, que define as categorias de bens e serviços específicos da área da saúde cujos contratos públicos de aprovisionamento (CPA) e procedimentos de aquisição são celebrados e conduzidos pelos SPMS - Serviços Partilhados do Ministério da Saúde, E. P. E. read more >
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Plataforma MEDVETA partir de hoje, encontra-se disponível no portal da DGAV a informação relativa aos medicamentos veterinários (MV) autorizados, inseridos numa plataforma - MEDVET - a qual pretende ser uma ferramenta de trabalho para todos os envolvidos no domínio do medicamento veterinário, facilitando o acesso e consulta da informação relevante para uma utilização correta e racional dos medicamentos veterinários. read more >
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Public consultation on a new notice on orphan medicinal products launched on 17/11/2015The European Commission is proposing to review the 2003 Communication on orphan medicinal products to streamline the regulatory framework and to adapt the Communication to technical progress. The 2003 Communication will be replaced by a notice. read more >
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New strategy to fight antimicrobial resistanceThe European Medicines Agency has released for public consultation a new strategy on antimicrobials for 2016-2020 adopted by its Committee for Veterinary Medicinal Products (CVMP). The strategy, recognising that antimicrobial resistance is a global problem affecting both animal and human health, sets clear objectives based on a 'One Health' approach to help combat the threat of resistance which may arise from the use of antimicrobials in animals. read more >
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AVISO Manutenção no sistema informático da PhageconA Phagecon informa todos os seus clientes que a partir das 14h (horas locais) do dia 01/10/2015 até ao final do dia 05/10/2015 irá proceder a operações de manutenção no seu sistema informático pelo que os seus colaboradores terão acesso condicionado aos seus emails, telefones, bem como a todos os recursos internos informáticos da empresa.
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Medicinal products for human use: monthly figures - August 2015This document provides current information related to the volume and evaluation of marketing authorisation and post-authorisation applications for medicinal products for human use received by the European Medicines Agency. read more >
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Training Course: CTD Module 3: Chemistry, Manufacturing and ControlsA Phagecon Serviços e Consultoria Farmacêutica, Lda vem, por este meio, apresentar uma nova solução no âmbito de formação altamente especializada, que garante um completo entendimento dos requisitos regulamentares europeus, no âmbito do Módulo 3 (CTD) de Medicamentos de Uso Humano.
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Improving health interventions with the support of the EU Health and DPIP Programme (Addiction 2015 conference, 2325 September 2015 -Lisbon, Portugal
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Draft concept paper on requirements for the production and control of allergen products for use in animalsDraft: consultation open read more >
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European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applicationsThis document addresses a number of questions which users of the Centralised Procedure may have. It provides an overview of the EMA position on issues, which are typically addressed during the course of Pre-Submission Meetings. read more >
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Frequently asked questions about parallel distributionThis page lists questions about parallel distribution. The information is available as questions and answers, which the European Medicines Agency (EMA) revises as necessary. read more >
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CEN adopts at European level new revised editions of international standards for management systemsCEN has adopted at European level new revised editions of three of the most successful and widely-used international standards. These standards, which are also recognized as European Standards, may be used by businesses and other organizations wishing to implement Quality Management Systems (EN ISO 9000 and EN ISO 9001) and Environmental Management Systems (EN ISO 14001). Applying these standards can deliver benefits in relation to performance, productivity, efficiency and savings (in terms of costs, energy and waste), leading to higher levels of satisfaction among customers and service-users, employees and other stakeholders. read more >
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Guideline on the evaluation of medicinal products for the treatment of chronic constipation and for bowel cleansingAdopted read more >
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List of Union reference dates and frequency of submission of periodic safety update reports (PSURs)
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Orientações para a utilização prudente de agentes antimicrobianos na medicina veterinária
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eXtended EudraVigilance medicinal product dictionary data-entry tool user manual
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EU: New GMP Implementing Act publishedThe EU Commission has published a new public consultation on an Implementing Act on GMP principles and guidelines for medicinal products for human use. read more >
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Joint European Medicines Agency/Drug Information Association information day on International Organization for StandardizationEuropean Medicines Agency, London, UK, From: 23-Jun-2015, To: 23-Jun-2015. This information day is primarily aimed at providing stakeholders with information to help prepare for the business change to come and at sharing the vision of common European Union (EU) strategy for the International Organization for Standardization (ISO) identification of medicinal products (IDMP) standards implementation in response to a worldwide demand for internationally harmonised specifications for medicinal products. Topics to be addressed relate to background of the IDMP standards and legislation, structure of the IDMP standards, international stakeholders perspective and identification of future direction. This forum is providing opportunity to understand requirements, identify key challenges and to exchange views between regulators, industry, system developers and other stakeholders. Places limited. read more >
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How to apply for orphan designationThis page provides information for sponsors on how to apply to the European Medicines Agency for orphan designation for a medicine. read more >
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Task force for the implementation of International Standards on Identification of medicinal products in the EU (i.e. EU ISO IDMP task force)The Task Force for the implementation of International Standards on Identification of Medicinal Products for human use in the EU (i.e. EU ISO IDMP Task Force) is an expert working group/advisory group co-chaired by an EMA representative, National Competent Authority (NCA) representative and European Pharmaceutical Industry representative. The group comprises of participants from the European Medicines Agency (EMA), Member States, experts nominated by European Pharmaceutical Industry Associations, Software Vendors and interested parties with full understanding of the terminology, the ISO IDMP standards, the European data policies, regulatory procedures and requirements including the data submission practices and the technological constraints of the existing IT infrastructure and applications. read more >
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Requirements on Submissions for Periodic safety update reports (PSUR) to National Competent Authorities (NCAs) for products authorised via National Pr
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EMAs medical literature monitoring enters into full operationThe European Medicines Agency (EMA) starts its full medical literature monitoring service on 1 September 2015. read more >
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FDA Submits Biological Products Naming Rule to OMBThe FDA wouldnt comment on whether the proposal is the expected guidance on naming biosimilars. read more >
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Pharmacovigilance legislationThe new pharmacovigilance legislation, which came into effect in July 2012, was the biggest change to the regulation of human medicines in the European Union (EU) since 1995. It had significant implications for applicants and holders of EU marketing authorisations, as well as for patients, healthcare professionals and regulators. read more >
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Resumo das decisões da União Europeia relativas às autorizações de introdução no mercado dos medicamentos de 1 de julho de 2015 a 31 de julho de 2015
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Summaries of scientific recommendations on classification of advanced-therapy medicinal productsThis page lists the outcome of the assessment of the classification of advanced-therapy medicinal products by the Committee for Advanced Therapies. read more >
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Updated guidance on good clinical practice released for consultationThe European Medicines Agency (EMA) has released an addendum to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 (R2) guideline on good clinical practice (GCP) for a six-month public consultation. read more >
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Sistema de Preços de Referência - Aditamento de novos grupos homogéneosA lista dos Grupos Homogéneos e dos preços de referência unitários a vigorar no 3.º trimestre de 2015 será atualizada com a inclusão de 11 novos grupos homogéneos, para os quais foi aprovado o respetivo preço de referência (GH1049, GH1050, GH1051, GH1052, GH1053, GH1054, GH1055, GH1056, GH1057, GH1058 e GH1059). read more >
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Needs for paediatric medicinesThe European Medicines Agency is developing an inventory of the needs for paediatric medicines, to help medicinal-product developers identify opportunities. read more >
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Submissão de Pedidos de Avaliação Prévia - Formulário para definição de preços máximos de aquisição de medicamentos de uso hospitalar
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BUV - biocidas de uso veterinário autorizados contendo iodo como substância ativaO Regulamento de Execução (UE) n.º 94/2014, da Comissão de 31 jan. 2014 aprova a utilização da substância ativa iodo, incluindo a polivinilpirrolidona-iodo, em produtos biocidas dos tipos 1, 3, 4 e 22 e fixa o dia 01 de setembro de 2015 como data de aprovação do Iodo e Polivinilpirrolidona-iodo na lista da União de substâncias ativas aprovadas. read more >
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PMF dossier requirements: question and answers on blood establishments inspection status in the plasma master fileThis Question and Answer (Q&A) describes the approach applied in evaluation of the compliance status of blood establishments (BE) registered in Plasma Master File (PMF) applications. It supplements the guidance provided in the PMF Scientific requirements Guideline EMEA/CHMP/BWP/3794/03 (current version). Together with the Q&A, a flow chart is also provided. read more >
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Annual report of the Pharmacovigilance Inspectors Working Group for 2014This document is the seventh annual report of the Pharmacovigilance Inspectors Working Group. read more >
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Outcomes of periodic safety update report single assessmentsThe European Medicines Agency (EMA) publishes the outcomes of single assessments of periodic safety update reports (PSURs) for active substances or combinations of active substances contained in medicines authorised in the European Union (EU). read more >
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Guidelines on good pharmacovigilance practices (GVP)Introductory cover note, last updated with revision 1 of module IV on audits and launch of public consultation of module VIII and its addendum I on post-authorisation safety studies. read more >
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Recommendations on minor-use-minor-species and limited-market classificationsThis page list recommedations on minor-use-minor-species (MUMS) and limited-market classification from the Committee for Medicinal Products for Veterinary Use (CVMP). read more >
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Outcomes of periodic safety update report single assessmentsThe European Medicines Agency (EMA) publishes the outcomes of single assessments of periodic safety update reports (PSURs) for active substances or combinations of active substances contained in medicines authorised in the European Union (EU). read more >
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Reporting requirements for marketing-authorisation holdersMAHs are required to submit information on new marketing authorisations within 15 calendar days from the date of notification of the granting of the marketing authorisation by the National Competent Authority (NCA). read more >
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ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients questions and answersICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients questions and answers - Step 5 read more >
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Submissão de traduções (processos de Autorização de Introdução no Mercado, Renovação e Alteração)Com o objetivo de simplificar o processo de avaliação das traduções dos resumos das características do medicamento (RCM), dos folhetos informativos (FI) e das rotulagens, no âmbito dos pedidos de autorização de introdução no mercado (AIM), alteração aos termos de AIM e renovação pelos procedimentos de reconhecimento mútuo e descentralizado, o Infarmed adotou as seguintes medidas:
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Public-friendly information on herbal medicines now availableSummaries to help people make informed choices when taking herbal medicines From now on the European Medicines Agency (EMA) will systematically publish summaries of the recommendations of its Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of a herbal substance in easy to understand, public-friendly language. read more >
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Recommended submission dates for centralised (initial and extension applications) and maximum-residue-limit procedures 1st phase(120-day assessment)
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Regulatory information Rules on fees are revisedThe European Medicines Agency (EMA) has revised the implementing rules on fees payable to the Agency. The revised implementing rules, which come into effect on 1 August 2015, were adopted by EMA Management Board on 14 July 2015. read more >
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European Medicines Agency pre-authorisation procedural advice for users of the centralised procedureThis integrated version has been created for printing purposes only. Please refer to the individual question & answers as published in the pre-submission guidance for access to the hyperlinked information. read more >
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European Medicines Agency regulatory tools for early access to medicinesConditional marketing authorisation and accelerated assessment draft revised guidelines Description of tools and overview of changes read more >
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Quick Response (QR) codes in the labelling and package leaflet of centrally authorised medicinal productsWith the availability of new communication technologies it has become apparent that patients/users of medicinal products may benefit from information provided through electronic formats. In this context, there has been an increased demand by applicants to the centralised procedure to include QR codes in the labelling and/or package leaflet (PL) of medicinal products as an additional way of providing information to patients and health care professionals. read more >
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EMA/PDCO Summary Report on the review of the list of granted Class WaiversThe review and update of waivers (of medicine development for children) is a task of the Paediatric Committee (PDCO) at the European Medicines Agency, as per Article 14 of Regulation (EC) No 1901/2006 (the Paediatric Regulation). The primary aim of this Regulation is to facilitate the development and accessibility of medicinal products for the paediatric population, by offering support for paediatric medicine development, including where this development has not been considered by the pharmaceutical sector. read more >
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Concept paper on the need for a single note for guidance on the chemistry of active substancesDraft: consultation open read more >
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Calculating 'chargeable units' for pharmacovigilance fees as specified in Regulation (EU) No 658/2014The purpose of this document is to describe the method used by the European Medicines Agency, hereafter referred to as the Agency, to determine the number of chargeable units applicable to each marketing authorisation holder for the purpose of levying pharmacovigilance fees. The pharmacovigilance fees referred to in this document relate to the fees laid down in Regulation (EU) No 658/2014 which enables the Agency to collect fees for the conduct of pharmacovigilance activities as assigned to it by the 2010 Pharmacovigilance Legislation that became applicable in July 2012. read more >
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Regulamento (UE) 2015/1190 da Comissão, de 20 de julho de 2015Regulamento (UE) 2015/1190 da Comissão, de 20 de julho de 2015, que altera o anexo III do Regulamento (CE) n.o 1223/2009 do Parlamento Europeu e do Conselho relativo aos produtos cosméticos read more >
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Concept paper on the need for revision of the note of guidance on manufacture of the finished dosage formDraft: consultation open read more >
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Reflection paper on the use of cocrystals of active substances in medicinal productsAdopted read more >
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Public register of parallel distribution now availableThe European Medicines Agency (EMA) is launching a public register of parallel distribution notices, providing a more transparent and user-friendly access to information on centrally authorised medicines put on the market by means of parallel trade in the European Union (EU). read more >
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An Addendum to ICH M7 provides practical Examples to calculate compound-specific Acceptable IntakesThe ICH M7 Guideline has reached Step 4 of the ICH process in June last year. It outlines recommendations for the assessment and control of mutagenic impurities that are present or expected to be present in drug substances or drug products, taking into consideration the intended conditions of human use. read more >
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European Medicines Agency pre-authorisation procedural advice for users of the centralised procedureThis guidance document addresses a number of questions which users of the centralised procedure may have. It provides an overview of the European Medicines Agencys position on issues, which are typically addressed during the course of pre-submission meetings. read more >
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Training Course: Pharmaceutical Semi-Solid Dosage Form: Development, Manufacture & Scale-UpA Phagecon vem por este meio apresentar uma nova solução no âmbito da Formação altamente especializada para profissionais de Desenvolvimento e Produção. O curso é destinado a pessoas que trabalham no desenvolvimento de formulações semissólidas, seleção de matérias-primas, sistemas de libertação controlada, scale-up e processo de fabrico, validação e testes de qualidade.
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Decisão de Execução (UE) 2015/1131 da Comissão, de 10 de julho de 2015Decisão de Execução (UE) 2015/1131 da Comissão, de 10 de julho de 2015, que altera a Decisão de Execução 2013/505/UE que autoriza a medida provisória tomada pela República Francesa, em conformidade com o artigo 129.o do Regulamento (CE) n.o 1907/2006 do Parlamento Europeu e do Conselho relativo ao registo, avaliação, autorização e restrição dos produtos químicos (REACH), no sentido de limitar a utilização de sais de amónio em materiais de isolamento em pasta (ouate) de celulose [notificada com o número C(2015) 4470] read more >
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Draft guideline on manufacture of the finished dosage formDraft: consultation open read more >
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Day 80 assessment report non-clinical and clinical guidance - generics rev05.15
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Implementação de pagamento por cartão de crédito - Plataformas SMUH-AIM e SMUH-ALTERAs plataformas online Sistema de Gestão de Medicamentos de Uso Humano (SMUH-AIM e SMUH-ALTER) integram o pagamento das taxas aplicáveis através da geração de referências multibanco. No entanto, esta forma de pagamento não está disponível para pagamentos oriundos do estrangeiro, os quais são atualmente efetuados por transferência bancária.
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Implementação de pagamento por cartão de crédito - Plataformas SMUH-AIM e SMUH-ALTERA Phagecon - Serviços e Consultoria Farmacêutica, Lda., gostaria de informar os seus clientes que o INFARMED I.P. Autoridade Nacional do Medicamento e Produtos de Saúde, publicou, a 07 de julho de 2015, a Circular Informativa N.º 124/CD/100.20.200 (que pode consultar aqui), dirigida a todos os Titulares de AIM e requerentes, relativa ao modo de pagamento de taxas resultantes de submissões nas Plataformas SMUH-AIM (pré-submissão eletrónica de pedidos de autorização de introdução no mercado (AIM)) e SMUH-ALTER (submissão eletrónica de pedidos de alteração aos termos da AIM).
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Q&As for Variations and Pharmacovigilance legislationThis Question and answers section gives advice on regulatory issues in connection with the Mutual Recognition and Decentralised Procedures. Reference is made, where additional information is available from CMDh guidance documents. read more >
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News bulletin for pharmacovigilance programme update - Issue 4This 4th update document captures the important progress made in the development of the pharmacovigilance information systems and services and describes how the Agency is preparing for the successful delivery of these changes, focusing on the most critical questions: what needs to be done by whom and by when. read more >
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Procedural timetablesThis page lists the timetables for the submission, start and finish dates of procedures, as well as other interim dates and milestones that occur during the various procedures. read more >
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Regulatory information Mandatory use of common repository for human centralised procedures as of yesterdayAs of yesterday, 1 July 2015, companies should no longer send their centralised procedure applications for human medicines to individual Member States on CDs/DVDs or via the Common European Submission Platform (CESP). read more >
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Validation checklist for initial marketing authorisation applications pharmaceuticalsThis validation checklist is used by the Agency to validate initial marketing authorisation applications for pharmaceuticals and applicants should use it as a means to review in advance of their submission that standard requirements are fulfilled. read more >
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Dossier requirements for centrally authorised productsSubmission of applications to the European Medicines Agency, Members of the Committee for Medicinal Products for Human use (CHMP), Committee for Advanced Therapies (CAT)* and Pharmacovigilance Risk Assessment Committee (PRAC) read more >
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Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2014This document is the first annual report of the GMP/GDP Inspectors Working Group (GMDP IWG). This group was established at EMA in 1996. read more >
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ICH Q7 Q&A on GMP for APIICH has published the ICH Q7 Questions & Answers on Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. PIC/S contributed to this Q&A document which provides interpretation to GMP for APIs since the implementation of the ICH Q7 Guideline. The ICH Q7 Guideline is originally based on a PIC/S draft guideline on API and was adopted by PIC/S in 2001, then integrated as part II of the PIC/S GMP Guide in 2007. read more >
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'Excipients in the label and package leaflet of medicinal products for human use'Draft: consultation open read more >
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Pharmacovigilance: Information systems and servicesSupporting business activities of the revised pharmacovigilance legislation through better information systems read more >
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DECRETO-LEI N.º 118/2015 - DIÁRIO DA REPÚBLICA N.º 120/2015, SÉRIE I DE 2015-06-23Procede à segunda alteração ao Decreto-Lei n.º 136/2003, de 28 de junho, que transpôs a Diretiva n.º 2002/46/CE, do Parlamento Europeu e do Conselho, de 10 de junho de 2002, relativa à aproximação das legislações dos Estados-Membros respeitantes aos suplementos alimentares read more >
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DELIBERAÇÃO N.º 1157/2015 - DIÁRIO DA REPÚBLICA N.º 119/2015, SÉRIE II DE 2015-06-22Alteração do regulamento que define a lista de medicamentos cuja exportação ou distribuição para outros Estados membros da União Europeia e respetivas quantidades dependem de prévia notificação pelos distribuidores por grosso ao INFARMED, I. P. read more >
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PORTARIA N.º 181/2015 - DIÁRIO DA REPÚBLICA N.º 118/2015, SÉRIE I DE 2015-06-19Revoga a Portaria n.º 348/98, de 15 de junho, que aprova os princípios e normas das boas práticas de distribuição de medicamentos de uso humano e de medicamentos veterinários read more >
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WHO publishes final Guideline for Hold-Time StudiesAfter the WHO had released the second draft of the guideline for the design of hold time studies in March already, it now released the final version as part of the Technical Report Series 992. read more >
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Integrated surveillance of Noncommunicable diseases (iNCD); A European Union-WHO project
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Applying regulatory science to neonates: launch of the International Neonatal Consortium (INC)
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EMA getting ready for the publication of clinical dataThe European Medicines Agency (EMA) will hold a webinar on Wednesday 24 June to update stakeholders on the implementation of its policy on publication of clinical data. read more >
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Nota Informativa sobre BiocidasA partir de 1 de setembro de 2015, um produto biocida que contenha uma substância ativa cujo fornecedor da substância ou do produto não estiverem incluídos na lista elaborada pela Agência Europeia dos Químicos (ECHA), de acordo com o artigo 95.º do Regulamento (UE) n.º 528/2012, para o tipo de produto em causa, não pode ser disponibilizado no mercado nacional, mesmo que autorizado, ou notificado, pela autoridade competente nacional de acordo com as regras do período transitório. read more >
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The European Medicines Agency (EMA) has launched user-acceptance testing of updated electronic application forms (eAF) for centralised procedures of initial marketing authorisations, variations and renewals for human and veterinary medicines. Companies are invited to take part in the exercise and provide feedback on user experience with the updated forms. read more >
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Concept paper on the revision of the guideline on quality of herbal medicinal products/traditional herbal medicinal productsA simplified registration procedure was established for traditional herbal medicinal products (THMPs) for human use with Directive 2004/24/EC of the European Parliament and of the Council. Herbal medicinal products (HMPs) contain exclusively as active ingredients one or more herbal substances or herbal preparations or combinations thereof. read more >
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European Medicines Agency pre-authorisation procedural advice for users of the centralised procedureThis integrated version has been created for printing purposes only. Please refer to the individual question & answers as published in the pre-submission guidance for access to the hyperlinked information. read more >
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New USP Chapter on the Integrity of Pharmaceutical PackagingThe USP has described the future requirements for the integrity of pharmaceutical packaging in the Pharmacopeial Forum. New proposals about the content have been published - now in form of 4 general chapters on the integrity of packaging materials. read more >
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Standard operating procedure for annual review of VeDDRA list to be used in EudraVigilance VeterinaryThis document describes the steps taken to invite comments from national competent authorities and interested parties and to subsequently update the Combined VeDDRA1 list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (VMPs) used in the electronic reporting of adverse events to VMPs via EudraVigilance Veterinary (EVVet). The list shall be reviewed and updated annually. read more >
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PORTARIA N.º 150/2015 - DIÁRIO DA REPÚBLICA N.º 101/2015, SÉRIE I DE 2015-05-26Aprova os critérios de fixação da contribuição regulatória e das taxas de registo e as isenções, no âmbito da prossecução das atribuições pela Entidade Reguladora da Saúde, bem como os montantes, critérios de fixação das taxas de licenciamento e as isenções, no âmbito do regime jurídico que ficam sujeitos a abertura, a modificação e o funcionamento dos estabelecimentos prestadores de cuidados de saúde e revoga a Portaria n.º 52/2011, de 27 de janeiro read more >
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Ibuprofeno e dexibuprofeno - recomendações de segurançaO Grupo de Coordenação (CMDh) adotou as recomendações, de minimização do risco de problemas cardiovasculares, do Comité de Avaliação do Risco em Farmacovigilância (PRAC) da Agência Europeia do Medicamento (EMA) relativas aos medicamentos contendo ibuprofeno e dexibuprofeno, decorrentes da finalização da revisão de segurança divulgada na circular informativa N.º 063/CD/8.1.7 de 13/04/2015. read more >
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FDA finalizes Guidelines for BiosimilarsThe FDA issued the final version of three biosimilar guidance documents related to the BPCI Act from 2009. read more >
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Guidance for implementation of eligibility requirementsThis guidance aims at helping organisations that have been granted eligibility prior to the implementation of the revised criteria adopted in June 2014 (EMA/161137/2011 rev 1) as well as new applicants to understand what is expected from them in their efforts to comply with current requirements. The information contained therein should also support future re-assessments, as part of the annual financial re-evaluation and the two-yearly full re-evaluation of an organisations eligibility. read more >
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List of centrally authorised products requiring a notification of a change for update of annexesParallel distributors are only required to inform the EMA of changes to the labelling or leaflet related to any update of the annexes of marketing authorisation once a year in their annual update application, except in cases related to safety or quality issues. The following table lists the centrally authorised products for which the EMA requires a notification of change before implementation. read more >
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European Medicines Agency post-authorisation procedural advice for users of the centralised procedureThis integrated version has been created for printing purposes only. Please refer to the individual question & answers as published in the post-authorisation guidance for access to the hyperlinked information. read more >
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Nota Informativa CEIC sobre o fornecimento do Medicamento Experimental (ME) durante e após conclusão do ECO fornecimento do ME no contexto de ensaios clínicos está previsto na Lei 21/2014 de 14 de abril, no seu artigo 23.º (Fornecimento gratuito e uso compassivo). A CEIC pretende com a " Nota Informativa CEIC sobre o fornecimento do medicamento experimental (ME) durante e após conclusão do EC"esclarecer o seu entendimento acerca do conteúdo deste artigo. read more >
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EFPIA Welcomes WHO Statement on Clinical Trials Data DisclosureEFPIA welcomes theWorld Health Organizations Statement on Public Disclosure of Clinical Trial Results and is supportive of its assertion that the registration of all interventional trials is a scientific, ethical and moral responsibility. read more >
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ECA and PQG publish Chapter 6 of the interpretation of the EU GDP GuidelineThe ECA Foundation and the Pharmaceutical Quality Group (PQG) have been working on the interpretation of different chapters of the EU GDP Guideline. Now the group has finalized the work on chapter 6 - Complaints, Returns, Suspected Falsified Medicinal Products & Medicinal Product Recalls. read more >
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Responses to the public consultation on the revision of Annex 15: Qualification and ValidationResponses to the public consultation on the revision of Annex 15: Qualification and Validation read more >
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Standard operating procedure for processing of annual update notifications for parallel distributionThe purpose of this SOP is to define the procedure for processing the annual update notifications for parallel distribution in a consistent way. read more >
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Standard operating procedure for management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal productsTo enable a transparent procedure for the management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products following the granting of a central marketing authorisation by the European Commission and to ensure timely submission and assessment of the PSURs as well as the follow-up of the conclusions and recommendations of the Committee for Medicinal Products for Veterinary Use (CVMP). read more >
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Quality of medicines questions and answers: Part 2These questions and answers address a number of questions that have been brought to the attention of the Joint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working Party (QWP) by marketing-authorisation holders (MAHs) or European Economic Area (EEA) competent authorities, on matters related to the quality of medicines. They have been developed and are maintained by the QWP. read more >
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List of centrally authorised products requiring a notification of a change for update of annexesParallel distributors are only required to inform the EMA of changes to the labelling or leaflet related to any update of the annexes of marketing authorisation once a year in their annual update application, except in cases related to safety or quality issues. The following table lists the centrally authorised products for which the EMA requires a notification of change before implementation. read more >
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PEDIDO DE AVALIAÇÃO PELA CEIC DA CLASSIFICAÇÃO DE ESTUDOS COMO SENDO "ESTUDOS COM INTERVENÇÃO" OU "ESTUDOS SEM INTERVENÇÃO"Com a entrada em vigor da Portaria 63/2015 de 5 de março, os pedidos de classificação dos estudos carecem de avaliação formal pela CEIC e respetivo pagamento.
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European Medicines Agency post-authorisation procedural advice for users of the centralised procedureThis integrated version has been created for printing purposes only. Please refer to the individual question & answers as published in the post-authorisation guidance for access to the hyperlinked information. read more >
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Update of the USP Requirements for Packaging Materials made of PlasticsIn the Pharmacopeial Forum the USP has described the future requirements for packaging materials made of plastics. The original proposals were now revised, and new proposals were published with regard to the structure and content of the General Chapters on packaging materials made of plastics. For more information please see the Update of the USP Requirements. read more >
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Fecho - Feriado NacionalA Phagecon informa que as suas instalações estarão fechadas na próxima sexta-feira, 01 de maio de 2015, devido a feriado nacional, reabrindo segunda-feira, dia 04 de maio de 2015.
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Excipients labellingThe European Medicines Agency (EMA) publishes background documents on excipients to be included in the label and package leaflet of human medicines. read more >
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New industry stakeholder platform on the operation of the centralised procedureThis is the first event in a series of upcoming, semi-annual meetings between regulators and representatives of industry stakeholder organisations. It aims to provide an opportunity for both general updates and more focused discussions on specific processes or issues to support continuous improvement, and generally to foster a constructive dialogue with industry stakeholders. The meeting is providing an update on the current operations, achievements so far, and planned improvements. Particular focus is on the interface in interactions with the applicant during evaluation procedures as well as the management of variations. Registration by invitation only. Registration closed. read more >
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Concept paper on the development of a guideline on quality and equivalence of topical productsDraft: consultation open read more >
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The new requirements of the "Guidelines on the formalised risk assessment for excipients"The most important document so far as concerns "GMP for excipients" was published in the Official Journal of the European Union this year on 21 March. It has the somewhat ponderous title Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (document classification: 2015/C 95/02). We reported on this in our news EU Commission issues two final Guidelines: GMP for Excipients and GDP for APIs. read more >
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FechoA Phagecon informa que as suas instalações estarão fechadas na próxima sexta-feira, 03 de abril de 2015, devido a feriado nacional, reabrindo segunda-feira, dia 06 de abril de 2015.
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Inspeção - GVK BiosciencesO INFARMED, I.P. publicou hoje, no seu site, um Comunicado de Imprensa sobre a inspeção na GVK Biosciences.
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Período festivo de Natal e Ano NovoA Phagecon vem por este meio comunicar a todos os parceiros que irá estar encerrada no período de 24 de dezembro de 2014 a 4 de Janeiro de 2015, para férias de Natal e Ano Novo.
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FechoA Phagecon informa que as suas instalações estarão fechadas na próxima segunda-feira, 08 de dezembro de 2014, devido a feriado nacional, reabrindo terça-feira, dia 09 de dezembro de 2014.
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FechoA Phagecon informa que as suas instalações estarão fechadas amanhã, 15 de agosto de 2014, devido a feriado nacional, reabrindo segunda-feira, dia 18 de agosto de 2014.
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FechoA Phagecon informa que as suas instalações estarão fechadas amanhã, 04 de julho de 2014, devido a feriado municipal, reabrindo segunda-feira, dia 07 de julho de 2014.
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Regulamento (UE) n º 658/2014 do Parlamento Europeu e do Conselho de 15 de maio de 2014 relativo às taxas de farmacovigilânciaRegulamento (UE) n º 658/2014 do Parlamento Europeu e do Conselho de 15 de maio de 2014 relativo às taxas cobradas pela Agência Europeia de Medicamentos para a realização de actividades de farmacovigilância no que respeita aos medicamentos para uso humano.
Estas taxas serão cobradas aos titulares de autorização de introdução no mercado, cujos medimentos sejam objecto de tais procedimentos. Estas taxas não são aplicáveis aos procedimentos realizados a nível da União para que a avaliação foi iniciada antes de 26 agosto de 2014. 2.Taxa anual:
Esta taxa será aplicada a partir de 1 julho de 2015. Adicionalmente, o presente regulamento regula as taxas que são cobradas pela EMA. Assim, aos titulares de autorização de introdução no mercado não deve ser cobrada duas vezes a mesma actividade de farmacovigilância (por exemplo, a submissão de estudos PASS a outra autoridade competente). A Phagecon preparou um quadro comparativo em Português com o tipo de serviços e respectivas taxas tendo em consideração as variáveis descritas implicadas em cada uma das actividades de Farmacovigilância. Este poderá ser visto clicando no link acima ou colando o seguinte link no seu navegador: http://www.phagecon.pt/homepage/userfiles/downloads/Noticia_Tabela_PT.pdf read more >
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FechoA Phagecon informa que as suas instalações estarão fechadas amanhã, 10 de junho de 2014, devido a feriado nacional, reabrindo quarta-feira, dia 11 de junho de 2014.
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FechoA Phagecon informa que as suas instalações estarão fechadas amanhã, 18 de abril de 2014, devido a Férias de Páscoa, reabrindo segunda-feira, dia 21 de abril de 2014.
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Implementação do acordo ortográfico na base de dados Standard TermsA Phagecon informa que foi publicada, na base de dados Standard Terms da Comissão da Farmacopeia Europeia, uma revisão dos termos, em Português, com vista a implementar o acordo ortográfico atualmente em vigor.
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Eudravigilance DowntimeA EMA informou que vai, na semana de 17 de Março, iniciar procedimentos de manutenção do sistema EudraVigilance, pelo que a EudraVigilance Web Application (EVWEB PRODUCTION), incluíndo a Pós-Função, irá estar indisponível de segunda-feira, 17 de Março, a partir das 17:30h até quarta-feira, 19 de Março às 21:00h.
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Alteração às ComparticipaçõesA Phagecon, na sequência da Portaria nº45/2014, de 21 de fevereiro, retificada pela Declaração de Retificação nº11-A/2014, publica uma tabela comparativa, com as alterações aos grupos e subgrupos farmacoterapêuticos comparticipados, bem como uma listagem de medicamentos que perdem a comparticipação.
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Comunicação prévia de Congressos, Simpósios, Ações ou eventos científicos ou de divulgação de medicamentos - patrocínios no âmbito do n.º 1 do artigoA Phagecon informa que o INFARMED I.P., na sequência das alterações ao artigo 159.º do Decreto-Lei n.º 176/2006, de 30 de agosto, pelo Decreto-Lei n.º 128/2013, de 5 de setembro, esclarece que:
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Implementação das recomendações do PRAC - atualizaçãoAs recomendações de segurança do Comité de Avaliação do Risco em Farmacovigilância (PRAC) da EMA, adotadas na sequência da avaliação de sinais são mensalmente publicadas na página eletrónica da EMA.
A submissão de qualquer alteração deverá ser feita no prazo de 60 dias após a recomendação do PRAC (PRAC recommendations on safety signals), exceto quando outro calendário for indicado. read more >
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Decreto-Lei nº19/2014, de 5 de fevereiroO INFARMED I.P. publicou no dia 5 de fevereiro o Decreto-Lei 19/2014 que vem alterar o Decreto-Lei nº48-A/2010, de 13 de maio, na sua redação atual e o Decreto-Lei nº112/2011, de 29 de novembro, na sua redação atual. No decorrer destas modificações legislativas verificam-se alterações ao regime geral de comparticipações do Estado aos medicamentos, nomeadamente quanto aos medicamentos a incluir nos escalões de comparticipação, quanto à evidência de eficácia e efetividade e quanto ao valor mínimo do PVP dos medicamentos genéricos. Em segunda instância este Decreto-Lei vem ainda trazer alterações quanto às margens de comercialização para armazenistas e farmácias.
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Decreto-Lei n.º 19/2014. de 2014-02-05A Phagecon informa que foi publicado em Diário da Republica o Decreto-Lei n.º 19/2014, o qual procede à quarta alteração ao Decreto-Lei n.º 48-A/2010, de 13 de maio, que aprova o regime geral das comparticipações do Estado no preço dos medicamentos, e à terceira alteração ao Decreto-Lei n.º 112/2011, de 29 de novembro, que aprova o regime da formação do preço dos medicamentos sujeitos a receita médica e dos medicamentos não sujeitos a receita médica comparticipados.
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EMA anuncia próximos passos para a manutenção de informações sobre medicamentos autorizados pelos Titulares de Autorização de Introdução no MercadoA Agência Europeia de Medicamentos (EMA) divulgou hoje uma orientação para apoiar os titulares de AIM de atualizar as informações sobre os medicamentos autorizados que tenham sido apresentados à Agência, em conformidade com o Artigo 57 (2) da legislação de Farmacovigilância de 2010.
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Transparência e PublicidadeNa sequência das alterações ao artigo 159.º do Decreto-Lei n.º 176/2006, de 30 de agosto, pelo Decreto-Lei n.º 128/2013, de 5 de setembro, o INFARMED esclarece:
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Descontos aos utentes no preço dos medicamentosNa sequência da Circular Informativa n.º 105/CD/8.1.6. de 10/05/2013, o INFARMED esclarece o seguinte:
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Portal SIEXPO INFARMED lançou uma Circular Informativa relativa ao funcionamento do Portal SIEXP, onde serão notificados todos os dados de exportação, comércio intracomunitário e consumos de uma listagem de medicamentos, publicada na página desta novidade do INFARMED.
A transação apenas poderá ser efetuada caso o Infarmed não se pronuncie no prazo de 3 dias úteis após a notificação, pela sua proibição, no todo ou em parte. Consumos Todos os intervenientes no circuito do medicamento – Titulares de autorização de introdução no mercado (AIM), Distribuidores por Grosso e Farmácias – deverão reportar os consumos destes medicamentos, nas seguintes condições:
Para permitir a adaptação de todas as entidades, estabeleceu-se um período transitório de adequação, que terminou no dia 31 de dezembro de 2013. Pelo que, à presente data, todas as entidades estão obrigadas a cumprir o disposto nas Deliberações n.º 2100/2013, de 6 de novembro, e n.º 2092/2013, de 5 de novembro, e o conteúdo da presente Circular. read more >
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Revisão anual do preço de medicamentos genéricosA Portaria nº 4/2012 de 2 de janeiro, define as regras para a revisão dos preços de medicamentos, nomeadamente, o artigo 6º define as regras para a revisão anual do preço dos medicamentos genéricos.
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Manutenção do Sistema EudraVigilanceA Agência Europeia do Medicamento (EMA) informou que vai proceder a uma manutenção no sistema EudraVigilance de 10 a 11 e 17 a 18 de Janeiro. Durante estes períodos o sistema vai estar indisponível entre as 17:30h de sexta-feira até às 21:00h de sábado.
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Revisão anual de preços do mercado hospitalar - UpdateA Phagecon informa que, devido ao prazo estipulado pelo INFARMED, I.P. para a apresentação da revisão anual de preços do mercado hospitalar (27/12/2013), a Autoridade Competente identificou os medicamentos aos quais se aplica a Circular Informativa Nº289/CD/8.1.6 e enviou um e-mail apenas aos titulares de autorização de introdução no mercado dos medicamentos que requerem a revisão de preços dos medicamentos de mercado hospitalar.
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Revisão anual de preços do mercado hospitalarFoi publicada, no site do INFARMED a Circular Informativa Nº289/CD/8.1.6, referente à revisão anual de preços do mercado hospitalar.
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Alteração do Código Deontológico da ApifarmaO Código Deontológico da Apifarma Para as Práticas Promocionais da Indústria Farmacêutica e Para as Interações com os Profissionais de Saúde que entrou em vigor em Janeiro de 2012, foi alterado pelo novo Código Deontológico da Apifarma Para as Práticas Promocionais da Indústria Farmacêutica e Para as Interações com os Profissionais de Saúde e Instituições, Organizações ou Associações Constituídas por Profissionais de Saúde, a entrar em vigor em 2014.
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Período de NatalA Phagecon vem por este meio comunicar que irá estar encerrada no período de 26 a 31 de dezembro de 2013 para férias do Natal.
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Novo regime aduaneiro de AngolaFoi publicada a nova Pauta Aduaneira dos Direitos de Importação e Exportação de Angola (Decreto Legislativo Presidencial 10/13 de 22 de Novembro) a qual revoga a anterior Pauta de 2008 e altera o regime jurídico aduaneiro de Angola, designadamente:
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Revisão Anual de PreçosO Decreto-Lei n.º 112/2011, de 29 de novembro, na redação dada em último lugar pelo Decreto-Lei n.º 34/2013, de 27 de fevereiro, estabelece o regime de preços dos medicamentos. O n.º 2 do artigo 6.º do mesmo diploma prevê a definição anual, até 15 de novembro do ano precedente, por portaria do membro do Governo responsável pela área da saúde, dos três países de referência com base nos quais se procede à fixação dos preços.
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Recomendações do PRAC decorrentes da avaliação de sinais de segurançaNo âmbito da farmacovigilância, a avaliação de sinais de segurança, reveste-se de um papel essencial para garantir informação actualizada quanto a riscos e benefícios dos medicamentos.
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MANHÃS INFORMATIVAS DO INFARMED, I.P. Gestão de Acessibilidade do Medicamento (GAM)A nova plataforma GAM tem como finalidade a submissão e gestão dos pedidos de comparticipação e de avaliação prévia de Medicamentos de Uso Humano. Esta plataforma permite que todo o processo seja gerido exclusivamente em ambiente online.
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Estatuto do Medicamento: destaque das alterações mais relevantes (análise em tabela comparativa)O Decreto-Lei nº 128/2013, de 5 de setembro, procede à oitava alteração ao Decreto-Lei n.º 176/2006, de 30 de agosto, que estabelece o regime jurídico dos medicamentos de uso humano.
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Decreto-Lei n.º 103/2013 de 26 de julhoA Phagecon informa que foi publicado em Diário da Republica o Decreto-Lei n.º 103/2013, de 26 de julho, que procede à terceira alteração ao Decreto-Lei n.º 48-A/2010, de 13 de maio, que aprova o regime geral das comparticipações do Estado no preço dos medicamentos.
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Casos de reações adversas a medicamentosDe acordo com requisitos legais nacionais e europeus vigentes, os casos de reações adversas a medicamentos (RAM) devem ser notificados aos vários parceiros (Titulares de AIM, Autoridades Nacionais Competentes e Agência Europeia do Medicamento). Esta notificação por parte dos Titulares de AIM é, desde 20 de novembro de 2005, efetuada obrigatoriamente por transmissão eletrónica.
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Validação da informação da InfomedApós diversos pedidos de correção à Infomed, o Infarmed disponibiliza, através da base de dados, um acesso restrito para que cada titular de autorização de introdução no mercado (AIM) possa validar a informação referente à comercialização, preços e comparticipações dos seus medicamentos do mês atual e do mês seguinte.
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Alterações aos termos da Autorização de Introdução no MercadoIrão ocorrer duas grandes alterações em Portugal no que diz respeito à submissão de alterações aos termos da Autorização de Introdução no Mercado de medicamentos em Portugal.
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Diretiva sobre Medicamentos FalsificadosA partir do dia 2 de Julho de 2013 todos os Princípios Ativos que sejam fabricados fora da União Europeia (UE) e que são importados para a UE têm de ser devidamente acompanhados por uma confirmação por escrito por parte da entidade reguladora do país de exportação que garanta que os requisitos relativos às Boas Práticas de Fabrico (BPF) e controlo da fábrica de produção são equivalentes aos que são utilizados na UE.
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Circular Informativa do INFARMED, I.P. Nº 145/CD/8.1.6 de 25/06/2013Com a transposição da Diretiva nº 2010/84/EU, do Parlamento Europeu e do Conselho, de 15 de Dezembro, para o direito nacional através do Decreto-Lei nº 20/2013, de 14 de fevereiro, passou a ser obrigatória a nomeação de uma pessoa de contacto para questões de farmacovigilância devendo reportar à pessoa responsável pela Farmacovigilância. A pessoa de contacto precisa de reunir as seguintes condições:
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Plano de Gestão do Risco e Resumo de Sistema de Farmacovigilância - Pedidos de AIM e AIM autorizadas por procedimento nacionalO INFARMED, I.P. publicou na passada sexta-feira a Circular Informativa N.º 120/CD/8.1.6 que define um período de transição mais alargado para implementação dos novos requisitos da farmacovigilância, relativamente ao período anteriormente estabelecido pela Circular Informativa n.º036/CD/8.1.6, de 8 de março. Não existe obrigatoriedade de apresentação de um Plano de Gestão do Risco. Contudo, o Infarmed pode solicitá-lo, sempre que tal se justifique. Não existe obrigatoriedade de apresentação de um Plano de Gestão do Risco. Contudo, o Infarmed pode solicitá-lo, sempre que tal se justifique. Não existe obrigatoriedade de submissão do Resumo do Sistema de Farmacovigilância no decurso da avaliação do pedido. Contudo, os requerentes podem aproveitar esta ocasião para o anexar. Se a AIM for concedida sem a inclusão do Resumo do Sistema de Farmacovigilância, este terá de ser submetido na renovação ou através de uma alteração aos termos da AIM, até 21 de julho de 2015, consoante a que ocorra primeiro. AIM cujos pedidos foram submetidos em ou após 21 de julho de 2012 e já foram concedidas O titular da AIM tem de submeter as alterações aos termos da AIM para aprovação do Resumo do Sistema de Farmacovigilância e do Plano de Gestão do Risco até 27 de dezembro de 2013, sob pena de revogação da AIM concedida. Pedidos de AIM em avaliação submetidos entre 21 de julho de 2012 e 14 de fevereiro de 2013a) Processos em fase final de avaliação Entende-se como estando em fase final de aprovação os pedidos de AIM que tenham sido presentes ou se encontrem agendados para discussão no plenário da Comissão de Avaliação de Medicamentos. Estes processos serão concluídos sem inclusão do Resumo do Sistema de Farmacovigilância e do Plano de Gestão do Risco.O titular da AIM tem de submeter as alterações aos termos da AIM para aprovação do Resumo do Sistema de Farmacovigilância e do Plano de Gestão do Risco até 27 de dezembro de 2013, sob pena de revogação da AIM concedida. b) Processos em avaliaçãoPara os processos em que não tenha sido ainda iniciada a fase final de aprovação, os requerentes podem submeter o Resumo do Sistema de Farmacovigilância e o Plano de Gestão do Risco dentro do prazo máximo de 90 dias consecutivos após a publicação da presente circular. Aos processos que entretanto tenham atingido a fase final de avaliação, sem que tenham sido apresentados o Resumo do Sistema de Farmacovigilância e do Plano de Gestão do Risco, aplica-se a alínea anterior. Pedidos de AIM submetidos em ou após 15 de fevereiro de 2013 ainda em avaliação
Os requerentes têm de entregar o Plano de Gestão do Risco e o Resumo do Sistema de Farmacovigilância dentro do prazo máximo de 90 dias consecutivos após a publicação da presente circular. A não entrega da documentação no referido prazo constituirá motivo de indeferimento do pedido. Pedidos de AIM submetidos em 1 de julho de 2013A não apresentação do Plano de Gestão do Risco e do Resumo do Sistema de Farmacovigilância aquando a submissão do pedido, constituem motivo de invalidação do pedido. A Phagecon está disponível para esclarecer e apoiar os seus clientes e parceiros em qualquer necessidade relacionada com a supracitada alteração legislativa. Não hesite em nos contactar! read more >
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Novos requisitos de notificação para os titulares de autorizações de introdução no mercadoFoi ontem (05-06-2013) publicada no site da EMA uma notícia, com base nas alterações à legislação de farmacovigilância, sobre as novas exigências de notificação aos titulares de autorização de introdução no mercado. Alguns acontecimentos na área de farmacovigilância na União Europeia, vieram demonstrar a necessidade de um procedimento automático a nível Europeu em casos de problemas específicos de segurança de modo a garantir que uma questão é avaliada e tratada em todos os Estados-Membros em que o medicamento é autorizado. Assim, as alterações abaixo descritas, contribuem para reforçar a proteção da saúde do doente autorizando a Agência a tomar decisões apropriadas, incluindo desencadear procedimentos de recurso, quando necessário. Neste sentido, os titulares de autorizações de introdução no mercado de medicamentos humanos terão agora de declarar as razões que os levaram a realizar quaisquer das ações abaixo indicadas à Agência Europeia de Medicamentos (EMA), de acordo com as alterações à legislação de farmacovigilância de 2010 da União Europeia (UE): descontinuação ou suspensão temporária ou permanente da comercialização de um medicamento;retirada de um medicamento do mercado; um pedido para revogação de uma autorização de introdução no mercado; a intenção para não aplicar a renovação de uma autorização de introdução no mercado. Estas alterações foram adotadas em Outubro de 2012 e são aplicáveis aos medicamentos centralizados a partir de 5 de Junho de 2013: Para os medicamentos autorizados por procedimento nacional, estas alterações terão vínculo obrigatório a partir de 28 de Outubro de 2013. As alterações estipulam que, para além da notificação destas ações, os titulares de autorização de introdução no mercado têm a obrigação clara de declarar as razões para as tomar, em especial quando estas são baseadas em qualquer uma das seguintes justificações: o medicamento é prejudicial;o medicamento carece de eficácia terapêutica; o equilíbrio do risco-benefício do medicamento não é favorável; a composição qualitativa e quantitativa do medicamento não está de acordo com a declarada; foram identificadas questões de fabrico ou de inspeção. A maioria dos requisitos de notificações supracitados já se aplicam para medicamentos centralizados autorizados como parte das directrizes processos da Agência. Para medicamentos centralizados autorizados, os titulares de autorização de introdução no mercado devem continuar a seguir os processos descritos na diretriz atual sobre notificação de comercialização e de descontinuação. Devem continuar a notificar a Agência imediatamente através do líder da equipa do produto nomeado, da: retirada de um medicamento do mercado por razões de segurança;intenção de requerer a revogação de uma autorização de introdução no mercado; intenção para não aplicar a renovação de uma autorização de introdução no mercado. Revogações devido a questões de qualidade, fabrico ou inspeção devem ainda ser notificadas através do ponto de contacto para defeitos de qualidade e recolhas. Para medicamentos autorizados nacionalmente, as alterações à legislação significam que os titulares de autorização de introdução no mercado irão necessitar de notificar a EMA, para além do Estado-Membro em que o medicamento está autorizado, quando estas ações são tomadas com base em qualquer uma das justificações listadas acima. Realça-se que estas obrigações também se aplicam quando a ação baseada nestas justificações tem lugar num país terceiro (um país fora do Espaço Económico Europeu). A EMA está a trabalhar em conjunto com os Estados-Membros para definir um processo de notificação comum para os medicamentos, para os medicamentos aprovados pelos procedimentos acima descritos. Os documentos de orientação da EMA deverão estar actualizados de acordo com os novos requisitos a 28 de Outubro de 2013. Para consulta da noticia, por favor, siga o link acima indicado. read more >
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Rascunho sobre os BiossimilaresA primeira guideline sobre os Biossimilares foi emitida pela EMA em 2005 e levou à aprovação de 14 medicamentos enquanto outros 5 estão atualmente em avaliação. A EMA decidiu agora rever esta guideline e publicou um rascunho para consulta pública. Esta revisão tem como objetivo: 1. Fornecer clarificação respeitante à terminologia dos biossimilares;2. Providenciar uma maior clareza sobre os princípios da biossimilaridade, incluindo os aspetos de segurança e eficácia; 3. Clarificar requisitos que digam respeito à posologia, via de administração e formulação de biossimilares; 4. Aspetos globais escolha do produto de referência quando se conduz estudos clínicos e não clínicos. Uma das principais alterações é que agora é possível para os promotores de biossimilares compararem o seu biossimilar em certos estudos clínicos e em estudos não clínicos in vivo com um comparador autorizado fora do EEE desde que este comparador esteja autorizado por uma autoridade regulamentar com padrões científicos e regulamentares semelhantes aos da EMA. Este rascunho da guideline revista está disponível para consulta pública até 31 de outubro de 2013 PhageconServiços e Consultoria Farmacêutica, Lda. | Pharmaceutical Services and Consulting, Ltd. Rua Capitão Luís Gonzaga, nº 74 | Santo António dos Olivais | 3000 - 095 Coimbra | PORTUGAL Tel.: +351. 239 853 350 | Fax: +351. 239 853 359 E-mail: phagecon@phagecon.pt | URL: www.phagecon.pt read more >
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Despacho nº 6021/2013, Diário da República, 2ª série Nº89 9 de Maio de 2013Pelo disposto no nº5 do artigo 4º do DL nº19/2010 na redacção dada pelo DL nº 108/2011 de 17 de Novembro a Serviços Partilhados do Ministério da Saúde, E.P.E. (SPMS, E.P.E) é considerada central de compras. No âmbito das suas competências SPMS, E.P.E levou a efeito um concurso público (publicitado em DR, 2ª série nº 104, de 29/05/2012, agora concluído) para o CPA para aprovisionamento de: 1. Medicamentos Analgésicos2. Medicamentos Antipiréticos 3. Medicamentos Antidepressores No decorrer deste concurso ficou determinado que: 1. A SPMS, E.P.E divulga agora no site www.catalogo.minsaude.pt todas as características dos produtos abrangidos pelo CPA para os medicamentos supracitados;2. Para as Instituições e Serviços do Serviço Nacional de Saúde, salvo dispensa conferida por Despacho do membro do governo responsável pela área da Saúde, fica estabelecida a obrigatoriedade da aquisição ao abrigo do CPA presente no presente Despacho; 3. A aquisição deve ser feita com respeito do critério do mais baixo preço unitário constante do caderno de encargos; 4. As condições de fornecimento devem ser comunicados à SPMS, E.P.E; 5. Os CPA ao abrigo do CP 2012/44 têm a duração de um ano, sendo prolongados até ao máximo de 3 anos; 6. As alterações às condições de aprovisionamento entram em vigor no dia seguinte ao da respectiva autorização pela SPMS, E.P.E; Para verificar o catálogo resultante do concurso 2012/44 Analgésicos, Antipiréticos e Anti depressores, por favor consulte o link presente na nossa notícia. A Phagecon está disponível para esclarecer e apoiar os seus clientes e parceiros em qualquer necessidade relacionada com a supracitada alteração legislativa. Não hesite em nos contactar! PhageconServiços e Consultoria Farmacêutica, Lda. | Pharmaceutical Services and Consulting, Ltd. Rua Capitão Luís Gonzaga, nº 74 | Santo António dos Olivais | 3000 - 095 Coimbra | PORTUGAL Tel.: +351. 239 853 350 | Fax: +351. 239 853 359 E-mail: phagecon@phagecon.pt | URL: www.phagecon.pt read more >
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Redução das Taxas para Medicamentos ÓrfãosA EMA cancelou o procedimento em que os promotores de medicamentos conhecidos como órfãos tinham que informar sobre a sua intenção de submeter uma aplicação de forma a serem elegíveis a uma redução das taxas (no protocolo de assistência, a submissão da autorização de introdução de mercado e inspeções). Como resulto, a Agência não necessita agora de informações adicionais para avaliar a elegibilidade de medicamentos órfãos para a redução da taxa. Esta alteração tem várias consequências: 1. O documento Conselhos para o Procedimento de reduções das taxas para os medicamentos designados como órfãos foi retirado do site da EMA2. A SOP (SOP/H/3048) sobre o processo de redução das taxas sobre medicamentos órfãos está agora obsoleta. A Phagecon está disponível para esclarecer e apoiar os seus clientes e parceiros em qualquer necessidade relacionada com a supracitada alteração legislativa. Não hesite em nos contactar! PhageconServiços e Consultoria Farmacêutica, Lda. | Pharmaceutical Services and Consulting, Ltd. Rua Capitão Luís Gonzaga, nº 74 | Santo António dos Olivais | 3000 - 095 Coimbra | PORTUGAL Tel.: +351. 239 853 350 | Fax: +351. 239 853 359 E-mail: phagecon@phagecon.pt | URL: www.phagecon.pt read more >
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Documento de reflexão sobre o uso de metil- e propilparabeno como excipientes nos medicamentos de uso humano para via oral.A EMA publicou um rascunho de uma guideline para consulta pública sobre o uso de metil- e propilparabeno como excipientes nos medicamentos para uso humano para via oral. Os esteres para-hidroxibenzoatos e os seus sais sódicos, normalmente conhecidos como parabenos, têm sido utilizados durante muitas décadas como conservantes antimicrobianos em cosméticos, produtos alimentares e formulações farmacêuticas. Os parabenos são eficazes com intervalo de pH abrangente com um elevado espetro de atividade antimicrobiana e são também eficazes contra fungos e leveduras. A atividade antimicrobiana aumenta com a duração aumentada da cadeia alquil para os parabenos metilo, etilo, propilo e butilo frequentemente utilizados, e tem sido notificada sinergia entre os parabenos. Nas formulações farmacêuticas orais, as associações de metilparabeno e propilparabeno são utilizadas com concentrações que normalmente alternam entre 0,015 a 0,2% para o metilparabeno e 0,02% a 0,06% para o propilparabeno. Outros parabenos como o etilparabeno e o butilparabeno são também utilizados na indústria farmacêutica em menor quantidade. Este último é predominantemente utilizado em formulações farmacêuticas para a via cutânea. O documento de reflexão atual foca-se nos parabenos mais frequentemente utilizados (metil- e propilparabeno), mencionando que a CHMP concluiu que os dados disponíveis dos estudos animais não representam um risco para os humanos. Contudo, são necessários mais dados para avaliar o potencial risco do propilparabeno em crianças com menos de dois anos de idade. Será necessário justificar caso-a-caso o uso de medicamentos que contenham propilparabeno neste grupo etário, pesando a necessidade de tratamento e o potencial risco. O metilparabeno não tem sido associado com efeitos adversos nos órgãos reprodutores masculinos e femininos em ratos jovens ou em estudos de desenvolvimento embrio-fetal. Tal permite concluir que o uso do metilparabeno em formulações orais em concentrações até 0,2% do produto (dentro das concentrações efetivas recomendadas para um conservante) não é uma preocupação para os humanos, incluindo a população pediátrica independentemente do grupo etário. No que diz respeito ao Propilparabeno, foi vista uma certa atividade estrogénica em várias configurações experimentais. Com base nos resultados publicados sobre o sistema reprodutor feminino, foi determinado um NOEL conservador de 250 mg/kg para o propilparabeno. Para crianças com menos de 2 anos, não pode ser determinado um PDE para o propilparabeno devido à incerteza relacionada com a maturação das enzimas que metabolizam o propilparabeno bem como à limitação dos dados animais disponíveis correspondentes a crianças mais jovens. Contudo, as margens de segurança identificadas em adultos e crianças com mais de 2 anos são atualmente tranquilizadoras. Não obstante, são necessários mais dados de exposição ao propilparabeno em crianças com menos de 2 anos. O uso de uma formulação que contenha propilparabeno em crianças muito jovens pode ser justificado caso-a-caso através de uma perspetiva benefício/risco, pesando a necessidade do tratamento e o risco potencial. Esta avaliação deve ter em conta vários fatores tais como a posologia e a concentração de propilparabeno, a duração do tratamento, a gravidade da doença e a disponibilidade de tratamentos alternativos. Um valor para o PDE de 5 mg/kg/dia pode ser calculado para o uso do propilparabeno em adultos e crianças com mais de 2 anos com capacidade metabólica de um adulto. Este rascunho da guideline está disponível para consulta pública até 31 de outubro de 2013. Para consultar este rascunho da guideline, por favor siga a hiperligação disponível acima. PhageconServiços e Consultoria Farmacêutica, Lda. | Pharmaceutical Services and Consulting, Ltd. Rua Capitão Luís Gonzaga, nº 74 | Santo António dos Olivais | 3000 - 095 Coimbra | PORTUGAL Tel.: +351. 239 853 350 | Fax: +351. 239 853 359 E-mail: phagecon@phagecon.pt | URL: www.phagecon.pt read more >
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Novas recomendações sobre o uso de ftalatos como excipientes em medicamentos de uso humanoA EMA publicou hoje uma proposta de guideline para consulta pública sobre o uso de ftalatos como excipientes em medicamentos de uso humano. Este grupo de excipientes é usado num vasto número de formas farmacêuticas orais, sólidas ou liquidas, devido às suas propriedades viscosantes e plastificantes, podendo ser incluídos em formulações de cápsulas de gelatina mole. Os ftalatos mais utilizados em medicamentos de uso humano são o ftalato de dibutilo (DBP), ftalato de dietilo (DEP), ftalato de acetato de polivinilo (PVAP), ftalato de acetato de celulose (CAP), e acetato ftalato de hidroxipropilmetilcelulose (HPMCP). Esta guideline tem como objetivo estabelecer limites nas quantidades usadas destes excipientes nos medicamentos face aos dados de estudos em animais que revelam efeitos adversos reprodutivos e no desenvolvimento em relação às suas propriedades anti androgénicas com a utilização dos ftalatos DBP, DEP e PVAP. Consequentemente, é proposto um limite de 0.01, 4 e 2 mg/kg/dia para os produtos DBP, DEP e PVAP, respectivamente. Os dados atualmente disponíveis para os ftalatos CAP e HPMCP não indicam que a sua presença em medicamentos de uso humano constitua um risco potencial para a saúde humana. As recomendações desta guideline devem ser consideradas como medidas preventivas, na ausência de evidência clínica de efeitos adversos em seres humanos devido ao consumo de ftalatos. Depois da entrada em vigor da guideline, no caso de medicamentos já autorizados, será dado um prazo de três anos para a implementação de mudanças de formulação e consequentes aplicações regulamentares. A presença em medicamentos de DBP, DEP ou PVAP em níveis que dão origem a exposições diárias acima do recomendado, podem ser admitidas excecionalmente, devendo ser avaliadas caso a caso, tendo em consideração a população afectada, a gravidade da doença e a presença de alternativas terapêuticas. A guideline estará disponível para consulta pública até Outubro de 2013. Para consulta da guideline, por favor, siga o link acima indicado. read more >
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Medicamentos sujeitos a monitorização adicional Existe um conjunto de medicamentos que necessita de uma monitorização especial pelas autoridades regulamentares, aos quais se chamam medicamentos sujeitos a monitorização adicional. ? Este medicamento está sujeito a monitorização adicional. O triângulo preto será usado, a partir do outono de 2013, nos FI dos medicamentos de todos os Estados-membros da EU. Este símbolo não vai constar na embalagem exterior dos medicamentos. Aplicação do triângulo pretoSe um medicamento estiver identificado com o triângulo preto, significa que está a ser alvo de uma monitorização acrescida. Esta situação normalmente ocorre quando existe menos informação disponível, por serem medicamentos novos no mercado ou existir pouca informação sobre a sua utilização a longo prazo, não significando que a sua utilização não seja segura. A denominação de medicamento sujeito a monitorização adicional aplica-se a todos os medicamentos nas seguintes situações: - contêm uma substância ativa nova autorizada na UE após 1 de janeiro de 2011;- Medicamentos biológicos tais como uma vacina ou um medicamento derivado do sangue ou plasma, para os quais exista uma experiência pós-autorização limitada; - têm uma autorização condicional (situações em que o Titular da Autorização de Introdução no Mercado tem de fornecer mais informação sobre o medicamento durante a sua comercialização); - são autorizados sob circunstâncias excecionais (quando existem razões específicas pelas quais o Titular da AIM não consegue fornecer mais informação); - necessitam de estudos adicionais, por exemplo, mais dados sobre a utilização a longo prazo ou sobre uma reação adversa rara observada durante os ensaios clínicos. - sejam alvo de decisão do Comité de Avaliação do Risco em Farmacovigilância (PRAC) da Agência Europeia do Medicamento (EMA). Lista Europeia de medicamentos sujeitos a monitorização adicional A inclusão dos medicamentos na lista pode ocorrer logo após a sua autorização ou em qualquer altura do seu ciclo de vida. Os medicamentos que constam da lista manter-se-ão durante cinco anos ou até decisão em contrário pelo PRAC. Pode existir um desfasamento entre a informação constante da lista e o folheto informativo existente nas embalagens dos medicamentos que se encontram no circuito comercial, pois é necessário substituir estes documentos que se encontram dentro das embalagens dos medicamentos. Aplicação dos conceitos de monitorização adicional e do símbolo- Todos os medicamentos autorizados a partir de 1 de setembro de 2013 e que estejam sujeitos a monitorização adicional já têm de incluir o triângulo preto no FI e no RCM; - Todos os medicamentos autorizados entre janeiro de 2011 e agosto de 2013 dispõem de um período transitório para a atualização dos FI e dos RCM, uma vez que esta legislação afeta apenas os medicamentos autorizados após 1 de janeiro de 2011; - Os materiais educacionais de medicamentos sujeitos a monitorização adicional têm de conter esta informação.Plano de Implementação O triângulo preto estará presente nos RCM e FI dos medicamentos sujeitos a monitorização adicional, a partir do outono de 2013. Para os novos medicamentos, os TAIM deverão começar a utilizar os novos modelos de RCM e FI, caso a opinião do CHMP esteja prevista para abril ou maio de 2013. No caso dos medicamentos cuja opinião do CHMP seja emitida partir de Junho de 2013, os TAIM deverão utilizar os novos modelos. Para os medicamentos que já se encontram autorizados, e para os quais esteja em curso uma alteração ao RCM/FI, os TAIM deverão utilizar os novos modelos, não sendo para o efeito necessário a submissão de uma alteração para introdução desta informação. A utilização dos novos modelos é obrigatória a partir de 1 de Janeiro de 2014, pelo que o TAIM deverá submeter uma alteração tipo IAIN até 31 de Dezembro de 2013 No plano de implementação estará descrito o procedimento regulamentar e o calendário que os TAIM deverão seguir. read more >
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Escoamento de preços de medicamentos decorrentes da revisão anual de preços e decorrente da revogação da dedução de 6%Na sequência do processo de revisão anual de preços decorrente da aplicação da Portaria nº 91/2013, 28 de Fevereiro, e da revogação da Portaria nº1041-A/2010, de 7 de Outubro, o Infarmed veio, através do envio desta circular, clarificar que se mantém aplicável a Portaria nº4/2012 de 2 de Janeiro, para efeitos de prazo de escoamento: 60 dias para Distribuidores / Grossistas90 dias para Farmácias Durante o período de escoamento devem ser consideradas as seguintes situações: Medicamentos que se encontram nos distribuidores e farmácias no dia 31 de Março Sujeitos a escoamento ao preço descontado, ou seja, o utente deverá continuar a pagar o mesmo valor pelos medicamentos; Medicamentos adquiridos pelos distribuidores e farmácias a partir do dia 1 de Abril, inclusive Deverão ser dispensados ao preço resultante da revisão anual de preços; A Phagecon está disponível para esclarecer e apoiar os seus clientes e parceiros em qualquer necessidade relacionada com a supracitada alteração legislativa. Não hesite em nos contactar! read more >
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Plano de Gestão do Risco e Resumo de Sistema de Farmacovigilância - Pedidos de AIM e AIM autorizadas após 21 de julho de 2012, procedimento nacionalO INFARMED, I.P. publicou ontem a Circular Informativa N.º 036/CD/8.1.6 com o objetivo de esclarecer a aplicação dos requisitos de apresentação do Resumo do Sistema de Farmacovigilância e do Plano de Gestão do Risco aos pedidos de Autorização de Introdução no Mercado (AIM) em avaliação e já autorizados, de acordo com as obrigações em matéria de farmacovigilância por parte dos titulares e requerentes de pedidos de Autorização de Introdução no Mercado (AIM) introduzidas na recente revisão do Decreto-Lei n.º 176/2006, de 30 de agosto. Esclarece a Circular: AIM concedidas antes de 21 de julho de 2012 AIM concedidas após 21 de julho de 2012 Pedidos de AIM em avaliação
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PLATAFORMA DE COMUNICAÇÕES - TRANSPARÊNCIA E PUBLICIDADEFoi publicado hoje pelo INFARMED, I.P., um documento de PERGUNTAS FREQUENTES relacionado com as comunicações que as entidades abrangidas pelos números 5 e 6 do artigo 159.º da redação atual do Decreto-Lei n.º 176/2006, de 30 de agosto deverão efetuar através da Plataforma de Comunicações Transparência e Publicidade disponível na área de Utilidades Serviços Eletrónicos (http://www.infarmed.pt/portal/page/portal/INFARMED/SERVICOS_ELECTRONIC S).
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Introdução do Símbolo Preto para identificação de medicamentos que estão sujeitos a monitorização adicional.Ontem, dia 7 de março de 2013, a Comissão adotou um Regulamento de Execução que introduz um Símbolo Preto para identificar medicamentos que estão sujeitos a monitorização adicional. Um triângulo preto invertido '?' irá aparecer no resumo das características do produto e no folheto informativo de certos medicamentos no mercado da UE. O símbolo preto irá permitir que os doentes e os profissionais de saúde identifiquem estes produtos sujeitos a monitorização adicional e o texto que o acompanha irá encorajá-los a notificar reações adversas. A partir de setembro de 2013, o símbolo preto será usado para identificar os referidos produtos farmacêuticos. São eles:
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Esclarecimentos adicionais sobre a revisão anual de preços de 2013O INFARMED, I.P. publicou no dia 08/03/2013 a Circular Informativa N.º 037/CD/8.1.6 com o objetivo de esclarecer algumas questões relacionadas com a revisão anual de preços de 2013. Salientamos os pontos mais importantes desta Circular: As disposições estabelecidas na Portaria n.º 4/2012, de 2/01 (ainda em vigor), mantêm-se válidas para o ano de 2013, nomeadamente os prazos de escoamento das embalagens e a não aplicação da revisão para os medicamentos com preço inferior a 5. O Quadro-síntese dos medicamentos não genéricos foi recentemente substituído de forma a contemplar a regra dos preços que, pela revisão, teriam de descer para valores inferiores a 5 ficassem no patamar dos 5 . Parecem existir algumas dificuldades na pesquisa de medicamentos nas bases de dados dos países de referência, sobretudo no que respeita à pesquisa por substância ativa. Assim, em caso de dúvida, não se deverá considerar esse comparador no país em causa. Em âmbito da validação por parte do INFARMED, I.P., serão feitas correções, à semelhança de anos anteriores. Esclarecimentos gerais:Os preços nos países de referência a utilizar na comparação são os praticados no 1.º dia de Fevereiro, uma vez que a revisão se processa no mês de março, de acordo com o disposto no art.º 7.o do Decreto-lei n.º 112/2011, de 29 de Novembro. read more >
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Publicação das novas guidelines da União Europeia para as Boas Práticas de Distribuição (2013/C 68/01).Foram ontem, 7 de março de 2013, publicadas as novas guidelines para as Boas Práticas de Distribuição (BPD) de Medicamentos de Uso Humano da União Europeia (2013/C 68/01). Numa primeira análise, o documento final publicado não aparenta ser significativamente diferente das versões para comentários previamente publicadas.
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Suspeitas de reações adversas não graves que ocorram em território nacionalO INFARMED, I.P. publicou ontem a Circular Informativa N.º 032/CD/8.1.6 com o objetivo de esclarecer o disposto no n.º 11 do artigo 7.º (Disposições Transitórias) do recentemente publicado Decreto-Lei n.º 20/2013, de 14 de fevereiro: Enquanto a Agência não puder garantir as funcionalidades da base de dados Eudravigilance, tal como descritas no artigo 24.º do Regulamento (CE) n.º 726/2004, do Parlamento Europeu e do Conselho, de 31 de março de 2004, os titulares da autorização de introdução no mercado devem, no prazo de 90 dias, a contar do conhecimento, notificar o INFARMED, I.P., de todas as suspeitas de reações adversas não graves que ocorram em território nacional.. Esclarece a Circular que os titulares da AIM só devem comunicar as suspeitas de reações adversas não graves que ocorram em território nacional quando expressamente solicitado pelo Infarmed.A decisão do Infarmed é fundamentada com base no n.º 5 do artigo 2.º da Diretiva 2010/84/UE, de 15 de dezembro de 2010 que permite às autoridades competentes dos Estados-Membros decidir, durante o período de transição, até a base de dados EudraVigilance estar concluída, sobre a obrigatoriedade da notificação das suspeitas de reações adversas sem gravidade que ocorram no território desse Estado-Membro. read more >
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Alterações ao Regime de preços dos MedicamentosForam hoje publicadas duas Circulares Informativas pelo INFARMED, I.P. com o objetivo de esclarecer como irá ser processada a revisão anual de preços de 2013 Circular Informativa N.º 032/CD/8.1.6. e quando produzirá efeitos a revogação da Portaria nº 1041-A/2010 (Dedução 6%) Circular Informativa N.º 033/CD/8.1.6. Desta forma salientamos os seguintes pontos:- Os novos preços dos medicamentos não genéricos (ambulatório e hospitalar) decorrentes da revisão devem ser comunicados ao Infarmed até 15 de março e entram em vigor a 1 de abril; - Devem ser utilizados os Formulários, Quadro-síntese e as Instruções para pedidos de aprovação de PVP disponíveis na página online do Infarmed, que entretanto serão atualizados; - Os PVPs resultantes da revisão devem ser notificados através do Sistema de Receitas e Cobrança de Taxas, os Formulários e o Quadro-síntese devem ser enviados por via eletrónica para o endereço aprovação.preco@infarmed.pt; - O pedido de alterações voluntárias de preço para os medicamentos não genéricos pode ser excecionalmente notificado até dia 15 de março em conjunto com a revisão; - A revogação da Portaria n.º 1041 -A/2010, de 7 de outubro que estabelecia uma dedução (6 % do PVP máximo autorizado) a praticar sobre os PVP máximos autorizados dos medicamentos de uso humano comparticipados, só produz efeitos a partir de dia 1 de abril 2013. Não foi ainda avançado pelo Infarmed como se processará a revisão anual de preço dos medicamentos genéricos. Para aceder às referidas Circulares Informativas por favor cole os seguintes links no seu browser. ? Circular Informativa N.º 032/CD/8.1.6. http://www.infarmed.pt/portal/pls/portal/docs/1/8454266.PDF ? Circular Informativa N.º 033/CD/8.1.6. http://www.infarmed.pt/portal/pls/portal/docs/1/8454269.PDF A Phagecon está disponível para esclarecer e apoiar os seus clientes e parceiros em qualquer necessidade relacionada com a supracitada alteração legislativa. Não hesite em nos contactar! Phagecon Serviços e Consultoria Farmacêutica, Lda. | Pharmaceutical Services and Consulting, Ltd. Rua Capitão Luís Gonzaga, nº 74 | Santo António dos Olivais | 3000 - 095 Coimbra | PORTUGAL Tel.: +351. 239 853 350 | Fax: +351. 239 853 359 E-mail: phagecon@phagecon.pt | URL: www.phagecon.pt read more >
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Alterações ao Regime de preços dos MedicamentosFoi publicado ontem o Decreto-Lei n.º 34/2013, de 27 de fevereiro que procede à alteração do Decreto -Lei n.º 112/2011, de 29 de novembro, diploma que estabelece o regime de preços dos medicamentos. As principais alterações introduzidas por este Diploma são: - São estabelecidos anualmente por Portaria três países de referência da União Europeia considerados para a revisão de preços anual que, face a Portugal, apresentem ou um produto interno bruto per capita comparável em paridade de poder de compra ou um nível de preços de medicamentos mais baixo. - Os medicamentos sujeitos a receita médica que não tenham sido objeto de avaliação prévia para efeitos de aquisição pelos hospitais do SNS, nem de decisão de comparticipação, ficam sujeitos a revisão anual: - se não existir outro medicamento autorizado ou comercializado, ou existir apenas medicamento original de marca e licenças, com a mesma substância ativa, dosagem e forma farmacêutica; - ou o medicamento tiver valores de consumo no ano anterior reportado pelos hospitais do SNS superior a milhão de euros. O preço de venda ao armazenista (PVA) revisto destes medicamentos não pode exceder o PVA mais baixo em vigor nos países de referência.
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Estatuto do Medicamento: nova alteração com republicação de todo o diploma (destaque de alterações mais relevantes)O Decreto-Lei n.º 20/2013, de 14 de Fevereiro, procede à sétima alteração ao Decreto-Lei n.º 176/2006, de 30 de Agosto, que estabelece o regime jurídico dos medicamentos de uso humano, e transpõe a Diretiva n.º 2010/84/UE do Parlamento Europeu e do Conselho, de 15 de Dezembro de 2010. Breve Resumo das Principais Alterações Introduzidas ao Estatuto do Medicamento pelo Decreto-Lei n.º 20/2013 Enquanto a Agência não puder garantir as funcionalidades da base de dados Eudravigilance, os titulares da autorização de introdução no mercado devem:
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Intervenções Sistema Telefónico PhageconEstimado cliente,
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Revisão de Normas Orientadoras referentes às Boas Práticas de Fabrico (BPF) de MedicamentosA Comissão Europeia divulgou no passado dia 17-01-2013, para consulta pública, versões revistas de alguns dos capítulos das normas orientadoras às BPF. Os capítulos em causa e respetivas alterações são:Capítulo 3: Instalações e Equipamento A única alteração ocorre na secção 6, como parte de uma norma orientadora melhorada, sobre a prevenção da contaminação cruzada (ver também Capítulo 5: Produção). É incluída a referência a uma nova norma orientadora sobre avaliação toxicológica complementar.Capítulo 5: Produção Foram feitas alterações nas secções 17 a 20 de forma a melhorar as orientações relativas à prevenção da contaminação cruzada e de forma a referir a norma orientadora sobre avaliação toxicológica. Foram também introduzidas alterações nas secções 26 a 28 (qualificação de fornecedores) refletindo a obrigação legal dos titulares de autorizações de fabrico de garantirem que as substâncias ativas são produzidas de acordo com as BPF. As alterações incluem rastreabilidade da cadeia de aprovisionamento. É adicionada uma secção adicional (33) para clarificar e harmonizar as expetativas dos fabricantes no que diz respeito à análise das matérias-primas. A secção (68) introduz diretrizes sobre a notificação de restrições no aprovisionamento.Os Capítulos 3 e 5 devem ser lidos em conjunto com a versão draft da norma orientadora da EMA sobre o estabelecimento de limites de exposição, com base na saúde, a utilizar na identificação do risco no fabrico de diferentes medicamentos em instalações partilhadas Capítulo 6: Controlo de Qualidade Inclusão de uma nova secção referente a Transferência Técnica de Métodos de Análise e outros itens tais como resultados fora de especificação.Capítulo 8: Reclamações, Defeitos de Qualidade e Retirada de Produtos do Mercado Refletir a aplicação dos princípios de Gestão de Risco na investigação de defeitos/reclamações e quando se tomam decisões em relação à retirada de produtos do mercado ou outras ações de diminuição do risco. Destacar a necessidade de investigar e determinar a(s) causa(s) dos defeitos/reclamações e que sejam implementadas as ações preventivas apropriadas para prevenir a recorrência da situação. Clarificar expectativas e responsabilidades no que diz respeito à notificação de defeitos de qualidade às autoridades competentes.Para consultar as normas orientadoras revistas para consulta publica cole o link http://ec.europa.eu/health/human-use/quality/developements/index_en.htm no seu browser. Comunicaremos qualquer aspeto relevante em relação a este processo e colocamo-nos à disposição para qualquer esclarecimento adicional. read more >
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Phagecon Conclusão de projeto de investimentoA Phagecon informa que concluiu em 2011 um investimento amplo, cofinanciado por verbas do QREN, que totalizou 165.156 euros e proporcionou a dotação de meios tecnológicos avançados, meios humanos qualificados e desenvolvimentos frutíferos em mercados internacionais. A Phagecon adquiriu maior dimensão e melhorou a sua capacidade de serviço, fatores importantes para maximizar a satisfação dos seus clientes. read more >
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The EMA has published the Reporting requirements of ICSRs applicable to MAH during the interim period (September 2012)Phagecon informs that it was published by the European Medicines Agency the Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to marketing authorisation holders during the interim period. During the interim period, in accordance with the transitional provisions set out in Article 2(4) and Article 2(5) of Directive 2010/84/EU, the reporting requirements detailed in tabular format in the link above (Table 1) shall apply to valid ICSRs reported by healthcare professionals and non-healthcare professionals. This is independent of the conditions of use of the suspected medicinal products and of the expectedness of the adverse reactions. Member States may request marketing authorisation holders to report electronically to EudraVigilance serious EU ICSRs originating in their territory. Those requirements are detailed in tabular format in the link above (Table 2). Member States reporting requirements during the interim period for serious non-EU ICSRs and for non-serious EU ICSRs are also presented in tabular format in the link above (Table 3). Phagecon provides support concerning all aspects of ICSRs management and other Pharmacovigilance obligations in the European Union. Contact us for more information.
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European Medicines Agency publishes list of EU reference dates and frequency of PSUR submissionPhagecon informs that it was published by the European Medicines Agency the list of European Union reference dates and frequency of submission of periodic safety update reports (PSUR) known as the 'EURD list'. The EURD list is a comprehensive list of active substances and combinations of active substances contained in medicinal products subject to different marketing authorisations, together with the corresponding Union reference dates, frequencies for submission of PSURs and related data lock points. The Union reference date corresponds to the date of the first marketing authorisation in the Union of a medicine containing that active substance or that combination of active substances, or alternatively the earliest of the known dates of the marketing authorisations for a medicine containing that active substance or that combination of active substances. The PSUR frequency and related data lock points for a given active substance or combination of active substances in the EURD list take effect six months after the publication date and overrule the submission schedule described in Article 107c (2) of Directive 2010/84/EU, and any conditions related to the frequency of submission of PSUR included in the marketing authorisation. Marketing authorisation holders are required to submit PSURs to the National Competent Authorities or the Agency according to the dates published in the EURD list. Marketing authorisation holders and other stakeholders can request amendments to the EURD list for the following reasons: Any changes to the list, following a request for amendment, are approved by the Committee for Medicinal Products for Human Use (CHMP) and the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) following consultation with the Pharmacovigilance and Risk Assessment Committee (PRAC). Changes take effect six months after the publication date of the amended list for the products containing the concerned active substance or combination of active substances. The EURD list aims to support and optimise the management of PSUR submission and PSUR (single) assessment within the European Economic Area. Phagecon provides support concerning all aspects of PSUR submissions and other Pharmacovigilance obligations in the European Union. Contact us for more information.
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Procedimento de Licenciamento das Unidades Privadas de SaúdeA Phagecon informa que foi publicada em Diário da República a Portaria n.º 290/2012, de 24 de Setembro, que no âmbito do Decreto-Lei n.º 279/2009, de 6 de Outubro, estabelece os requisitos técnicos a que deve obedecer o exercício da atividade das unidades privadas que prossigam atividades no âmbito da prestação de serviços de saúde e que disponham de internamento.
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Infarmed Inicia Operação de Fiscalização sobre Dificuldades de Acesso ao MedicamentoA Phagecon informa que o INFARMED no âmbito das suas competências enquanto entidade reguladora do medicamento e com o objetivo de controlar todas as situações que impeçam o regular abastecimento de qualquer medicamento no mercado nacional e o acesso dos utentes aos medicamentos de que necessitam, irá desencadear as seguintes ações:
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Extensão ao Procedimento Nacional do Regulamento das AlteraçõesA circular nº 190 do Infarmed informa que foi publicado, a 4 de agosto, o Regulamento (UE) n.º 712/2012 da Comissão, de 3 de agosto de 2012, que altera o Regulamento das Alterações (Regulamento (CE) n.º 1234/2008 da Comissão, de 24 de novembro de 2008). Este diploma estabelece as seguintes modificações: O Regulamento (UE) n.º 712/2012 é aplicável a partir de 2 de novembro de 2012, com exceção do artigo 1º - n.º 10, 15, 18, alíneas a) e c), 21, 22 e 23, os quais apenas são aplicáveis a partir de 4 de agosto de 2013. Assim, as alterações aos termos da AIM submetidas por procedimento nacional continuarão a estar sujeitas às regras nacionais de cada Estado Membro (em Portugal continua a aplicar-se o disposto no Decreto-Lei n.º 176/2006, de 30 de agosto). A extensão ao procedimento nacional do regulamento de alterações, tal como descrita no novo capítulo II-A do regulamento revisto, apenas será aplicável a partir de 4 de agosto de 2013. A Phagecon presta apoio aos seus clientes nesta e noutras temáticas regulamentares, encontrando-se ao seu inteiro dispor para qualquer esclarecimento necessário. Contacte-nos!
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Novas regras de importação de substâncias ativas farmacêuticas para a União Europeia No passado dia 25 de julho, a Comissão Europeia publicou um folheto informativo relativo às novas regras de importação de substâncias ativas para o fabrico de medicamentos de uso humano na europa. A partir de 2 de janeiro de 2013, todas as substâncias ativas importadas devem ser fabricadas em conformidade com os padrões definidos para as boas práticas de fabrico (BPF) europeias, que são os da ICH Q7. Igualmente a partir desta data, esta conformidade deverá ser confirmada por escrito pela autoridade competente do país exportador sendo que neste documento deverá também ser atestado que a unidade de fabrico está sujeita ao controlo e à execução das BPF europeias. O template relativo a este documento encontra-se no Folheto agora publicado. A Phagecon encontra-se à disposição dos seus clientes para o esclarecimento de qualquer questão adicional. read more >
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Alteração do Regime Jurídico e do horário de funcionamento das Farmácias de Oficina No passado dia 1 de agosto, foram publicados dois diplomas legais, Decreto-Lei n.º 171/2012 e Decreto-Lei n.º 172/2012 que alteram respetivamente o regime jurídico das farmácias de oficina (DL n.º 307/2007, de 31 de Agosto) e o seu horário de funcionamento (DL n.º 53/2007, de 8 de Março). De acordo com a referida legislação que entrou ontem em vigor, as farmácias que violem o dever de providenciar, com a brevidade possível, pela obtenção dos medicamentos solicitados que se encontrem esgotados passam a estar sujeitas a uma multa que poderá ir até 20 mil euros. O novo regime jurídico das farmácias vem reforçar algumas das contraordenações a que estas se encontram sujeitas. O primeiro diploma prevê ainda que as farmácias, caso não consigam os medicamentos nos fornecedores, possam pedi-los a outras farmácias. Passa a estar prevista uma contraordenação para os casos em que as farmácias não respeitam a prescrição médica, de acordo com a legislação em vigor. O segundo diploma introduz um regime excecional de funcionamento para as farmácias em que o valor de faturação ao SNS seja igual ou inferior a 60% da média a nível nacional. Estas farmácias só estarão obrigadas a ter um farmacêutico e não os dois obrigatórios por lei e poderão ter áreas e horários reduzidos. Esta exceção está dependente de comunicação por parte do INFARMED, I.P.. A Phagecon encontra-se à disposição dos seus clientes para o esclarecimento de qualquer questão adicional. read more >
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DGS - Atualização da área referente a Biocidas A Direção-Geral de Saúde procedeu a nova atualização dos conteúdos "Saúde de A a Z - Biocidas" do seu sítio Web, datada de 16 de julho de 2012. Salienta-se a publicação do Regulamento (UE) n.º 528/2012, de 22 de maio, relativo à disponibilização no mercado e à utilização de produtos biocidas, que substitui integralmente a Diretiva 98/8/CE, e que é aplicável a partir de 1 de setembro de 2013. A lista de diplomas de inclusão de substâncias ativas biocidas nos anexos I do Decreto-Lei n.º 121/2002 também foi atualizada dada a publicação recente de diretivas de inclusão. A Direção-Geral de Saúde prossegue com a atualização das listas de autorizações de venda emitidas de acordo com o período transitório (disponibilizadas no ponto 2.1.1 do texto "Saúde de A a Z - Biocidas"), bem como a da lista de autorizações por reconhecimento mútuo (disponibilizadas no ponto 4.2 do texto "Saúde de A a Z - Biocidas"). Foi ainda disponibilizada informação sobre os prazos de notificação das empresas do setor, relativos a determinados tipos de produtos biocidas, na sequência da publicação de diretiva de inclusão de substâncias ativas que esses produtos possam conter. A Phagecon disponibiliza apoio aos seus clientes em todas as atividades supramencionadas. Consulte-nos para o esclarecimento de qualquer questão adicional. read more >
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Update on the EMAs Q&A on practical transitional measures for the implementation of the pharmacovigilance legislationEMA has released an updated Question and Answer (Q&A) document on the practical considerations concerning the initial phases of operation of the new pharmacovigilance legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU). The Q&A applies to all medicinal products for human use regardless of the route of authorisation. Any specificities depending on the route of authorisation (i.e. centralized procedure versus mutual recognition/decentralised procedure and purely national procedure) are highlighted when appropriate. The Q&A document should be read in conjunction with Commission Questions and Answers on transitional arrangements. The questions and answers in this document represent the view of the EMA and Member States and have been subject to consultation with the European Commission. In case of doubt reference is given to the above-mentioned Union Directive and Regulation as well as to the Commission Implementing Regulation (EU) No 520/2012. This document provides a series of questions and answers to clarify procedural elements in relation to the implementation of the new legislation. The questions are organised into the following themes: The Regulation and Directive as referred to above enter into force respectively on 2 July and 21 July 2012. Therefore when referring to dates of application for both centrally authorised products (CAPs) and nationally authorised products (NAPs) including products authorised through the mutual recognition and decentralised procedures (MRP/DCP), the Q&A states 2 / 21 July 2012. This document is intended to be updated with additional clarifications as the implementation of the new pharmacovigilance legislation progresses. For queries in relation to a specific centrally authorised product, applicants/MAHs are advised to raise these with their Product Team Leader, especially for regulatory procedures which will start before July 2012 and will continue after July 2012 and may be affected by the new legislation. For queries in relation to a specific medicinal product authorised through the MRP/DCP, applicants/MAHs are advised to liaise with the Reference Member State. For purely nationally authorised medicinal products, the applicants/MAHs are advised to contact the relevant national competent authority. Please find the complete Q&A document on the link available above.
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Aprovação do preço dos medicamentos sujeitos a receita médica e não sujeitos a receita médicaCom a publicação do Decreto-Lei n.º 152/2012, de 12 de julho, o Infarmed passa, a partir de 1 de agosto de 2012, a ser a entidade competente para autorizar o Preço de Venda ao Público (PVP) dos medicamentos sujeitos a receita médica e dos medicamentos não sujeitos a receita médica comparticipados. Esta competência encontrava-se anteriormente atribuída à Direção Geral das Atividades Económicas (DGAE), a qual continuará a ser ouvida sobre esta matéria, para emissão de parecer não vinculativo, conforme previsto no n.º 1 do artigo 4.º do Decreto-Lei n.º 112/2011, de 29 de novembro, com a redação dada pelo Decreto-Lei n.º 152/2012, de 12 de julho. Pedido de aprovação de preço Pedido de revisões excecionais de preço (REP) Notificação de alterações temporárias de preço Declarações de preço Informações adicionais
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Portal RAM Infarmed possibilita notificação online de suspeitas de reações adversas a medicamentos por profissionais de saúde e utentesO Infarmed desenvolveu uma aplicação - Portal RAM - que permite facilitar e tornar mais célere a notificação das suspeitas de reação adversa a medicamentos (RAM) por parte dos profissionais de saúde e, simultaneamente, envolver os utentes no Sistema Nacional de Farmacovigilância. O Portal RAM surge no contexto da nova legislação europeia de farmacovigilância (Diretiva 2010/84/EU, de 15/12/2010), que introduziu alterações significativas nos sistemas nacionais de farmacovigilância, nomeadamente a possibilidade de notificação online de suspeitas de RAM pelos profissionais de saúde e, pela primeira vez, permitindo também aos utentes notificar suspeitas de RAM. Embora se pretenda convergir todas as notificações para o Portal RAM, manter-se-á disponível a notificação em papel, através dos formulários já existentes para os profissionais de saúde, criando-se também um novo formulário destinado aos utentes (disponibilizado em www.infarmed.pt). O Portal RAM está disponível a partir de hoje, dia 23 de julho de 2012, e pode ser acedido através do sítio do Infarmed na Internet (www.infarmed.pt) ou diretamente em http://extranet.infarmed.pt/page.seram.frontoffice.seramhomepage. A farmacovigilância contribui para um melhor conhecimento do perfil de segurança dos medicamentos, para uma utilização mais racional dos mesmos e, consequentemente, para a defesa da saúde pública. A notificação de qualquer suspeita de reação adversa é um contributo essencial para a monitorização contínua da segurança dos medicamentos, sendo necessária a colaboração de todos os utentes e profissionais de saúde. read more >
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Relatório de Junho do infarmed revela que encargos dos utentes com medicamentos diminuíram 5,7%.A última Análise do Mercado de Medicamentos em ambulatório do INFARMED Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. (Infarmed) referente a junho, demonstra que os encargos dos utentes com medicamentos diminuíram 5,7% face ao período homólogo (mercado SNS) e que o preço médio dos Medicamentos Genéricos atingiu o valor mínimo dos últimos 5 anos, situando-se agora nos 6,72. Estes valores confirmam a tendência de descida geral no preço dos medicamentos cujo mercado total diminuiu 11,8% em valor entre janeiro e junho de 2012 (1 317,9 milhões de euros) comparativamente a igual período de 2011 (1 494,7 milhões de euros), tendo-se registado, no mesmo período um aumento em embalagens de 2,0% (traduzindo um acréscimo de aproximadamente 2,3 milhões de embalagens). No mercado do SNS, os encargos com medicamentos, no período de janeiro a junho de 2012, foram 612,5 milhões de euros que reflete uma diminuição de 7,2% face ao período homólogo de 2011. Neste mercado, entre janeiro e maio de 2012, o valor a PVP registou uma descida de 5,5% face ao homólogo de 2011, o que contribuiu para a redução dos encargos do SNS com medicamentos (-5,4%) e a redução também dos encargos dos utentes (- 5,7%). No mercado de medicamentos genéricos, o preço médio global tem vindo a descer de forma sustentada desde 2º semestre de 2010. Em junho de 2012, foi atingido o valor mínimo dos últimos 5 anos (6,72) registando um decréscimo de 66,9% comparativamente a igual mês de 2007 (20,32). Em média, um medicamento genérico custa em junho de 2012 menos 4,03 do que em junho de 2011. Este comportamento do mercado traduz-se num crescimento da quota de mercado em volume, de 21,2% no primeiro semestre de 2011 para 24,5% no mesmo período de 2012, e redução da quota de mercado em valor, de 18,8% entre janeiro e junho de 2011 para 17% entre janeiro e junho de 2012. A quota de mercado em volume que atingiu pela primeira vez no anterior mês de maio um valor superior a 25%, mantendo-se nos 25,2% em junho de 2012. read more >
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Ministério da Saúde altera a lista de substâncias ativas que podem ser incluídas em produtos biocidas Este decreto-lei visa transpor para a ordem jurídica interna oito diretivas europeias que alteram o anexo I da Diretiva n.º 98/8/CE, do Parlamento Europeu e do Conselho, de 16 de fevereiro, relativa à colocação no mercado dos produtos biocidas (inseticidas, acaricidas, herbicidas, etc.). Os designados produtos biocidas compreendem uma vasta gama de substâncias ativas e de preparados que as contêm, de composição muito variada, e cobrem um amplo leque de utilizações, constituindo uma arma muito eficaz no combate aos organismos nocivos e atuando ao nível dos produtos e dos processos com nítido benefício para a proteção da saúde humana e animal, e para a salvaguarda do ambiente, desde que observadas determinadas condições. A harmonização legislativa gerada pela referida Diretiva n.º 98/8/CE tem em vista propiciar uma utilização segura para a saúde humana e animal, e para o ambiente, dos produtos biocidas necessários para o controlo dos organismos nocivos para o homem ou para a saúde animal e dos que provocam danos nos produtos naturais ou transformados. O citado anexo I constitui a lista de substâncias ativas biocidas cujos requisitos de inclusão em produtos biocidas foram decididos a nível europeu. A aprovação dessas substâncias depende de decisão da Comissão Europeia, no sentido de incluí-las num dos anexos I, I-A ou I-B da referida diretiva, precedida de avaliação por um Estado membro. O presente decreto-lei procede, assim, à transposição para o direito nacional das Diretivas n.os 2011/66/UE, 2011/67/UE, 2011/69/UE, da Comissão, de 1 de julho, da Diretiva n.º 2011/71/UE, da Comissão, de 26 de julho, e das Diretivas n.os 2011/78/UE, 2011/79/UE, 2011/80/UE, 2011/81/UE, da Comissão, de 20 de setembro, que determinaram a inclusão das substâncias ativas 4,5 -dicloro-2-octi l-2H -isotiazol-3-ona, abamectina, imidaclopride, creosote, Bacillus thuringiensis subsp. israelensis, serótipo H14, estirpe AM65 -52, fipronil, lambda -cialotrina, deltametrina no anexo I da Diretiva n.º 98/8/CE, de 16 de fevereiro, para os usos especificados. Para consultar o decreto-lei Decreto-Lei n.º 154/2012, de 16 de Junho por favor clique no link acima disponibilizado.
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Ministério da Saúde procede à primeira alteração ao DL n.º 112/2011 que aprova o regime da formação do preço dos MSRM e dos MNSRM comparticipad O Memorando de Entendimento firmado com a Troika determina a implementação de medidas específicas em relação ao regime de fixação de preços de medicamentos.
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European Medicines Agency finalises first set of guidelines on good pharmacovigilance practicesThe European Medicines Agency has published the first set of finalised modules of the guideline on good pharmacovigilance practices (GVP) on the 25th of June 2012. The finalisation of these seven modules is a key deliverable of the 2010 pharmacovigilance legislation, which will apply from Monday 2 July 2012. Each of the modules covers one major process in the safety monitoring of medicines. These are: GVP is a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). They apply to marketing-authorisation holders, the Agency and medicines regulatory authorities in EU Member States and aim to improve safety for patients by strengthening the monitoring of the safety of medicines across the EU. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level. Each module was developed by a team consisting of experts from the Agency and from EU Member States, and was released for public consultation between February and April 2012. The final versions of the modules have been updated, taking the comments received during the public consultation into account. The comments received have also been published today. The remaining seven draft modules making up the entire GVP package are under development and will be released for consultation later in the year. The GVP modules are aligned with the European Commission's implementing regulation , published last week. This regulation is a legally binding act that provides details on the operational aspects for the new legislation. The finalised GVP modules on post-authorisation safety studies and risk management plans refer to the guide on methodological standards in pharmacoepidemiology , which is available on the website of the European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP). This guide, which was revised last week after an extensive consultation period and expert review, includes methodological guidance for experienced and new researchers in pharmacoepidemiology and pharmacovigilance. For each topic covered, direct electronic access is given to internationally agreed recommendations and key points from important guidelines, published articles and textbooks after an introductory review. On the 25th of July was also published an updated version of the European Medicines Agency and Member States joint implementation checklist, which provides an overview of the prioritisation of tasks linked to the implementation of the legislation.
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EMA has Updated XEVMPD Frequently Asked Questions documentPhagecon informs that a new version of the eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) Frequently Asked Questions & Answers (FAQs) has been published by the European Medicines Agency (EMA) and it is now available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000336.jsp&mid=WC0b01ac05804d8b2b
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Síndrome de Steven-Jonhson (SSJ) e Necrólise Epidérmica Tóxica (NET) Na sequência da avaliação realizada pelo Grupo Europeu de Farmacovigilância (PhVWP), o INFARMED Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. informa que deve ser implementada uma atualização da informação de segurança de todos os medicamentos de uso sistémico que contenham uma das 14 substâncias ativas que apresentam um risco potencial elevado para a ocorrência de síndrome de Stevens-Jonhson (SSJ) e de necrólise epidérmica tóxica (NET). Apesar de serem muito raras, a SSJ e a NET são reações adversas cutâneas graves e potencialmente fatais. O grupo do projeto RegiSCAR (Registry of Severe Cutaneous Adverse Reactions) informou a Agência Europeia do Medicamento (EMA) dos resultados da análise efetuada às referências a reações adversas cutâneas graves constantes do Resumo das Características do Medicamento (RCM) e Folheto Informativo (FI) de vários medicamentos e à evidência que as fundamentam. Como não é possível atuar sobre a etiologia destas reações adversas, o diagnóstico precoce tem um papel primordial como medida de minimização do risco: se os doentes e os profissionais de saúde forem devidamente informados e alertados para os sinais e sintomas destas reações cutâneas, as medidas adequadas podem ser iniciadas mais cedo. O PhVWP acordou os elementos-chave que devem existir no RCM e no FI dos medicamentos com estas substâncias ativas. O objetivo é garantir que todos contêm informação clara e igual sobre estas reações adversas graves. Neste caso em particular, como acordado entre todos os Estados Membros, os Titulares de AIM destes medicamentos não serão notificados para a submissão de uma alteração de segurança específica. No entanto, esta informação de segurança deve ser implementada no âmbito do próximo procedimento regulamentar (exemplos: alteração aos termos da AIM ou renovação dos termos da AIM) em que sejam atualizados o RCM e o FI dos medicamentos em causa, tendo em consideração o seguinte: - Os elementos-chave sobre SSJ e NET devem servir de base à informação a incluir no RCM e FI; pode ser incluída informação adicional específica para cada substância ativa, dependendo da evidência disponível; - A informação deve ser clara e colocada com destaque na secção 4.4 do RCM e na secção 2 do FI (não deve ser colocada no fim das secções); - A informação sobre SSJ e NET deve ser adaptada a cada medicamento e a sua preponderância equilibrada face à informação já existente relativa a outras reações adversas graves.
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Spanish Medicines Agency updates national electronic submission guidanceThe Spanish Medicines Agency "Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)" has released an updated version 2.2 of their national electronic submission guidance "ENVÍO POR PARTE DE LOS LABORATORIOS DE INFORMACIÓN EN FORMATO ELECTRÓNICO A LA AEMPS".
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Governo Atribui ao Infarmed Responsabilidade pela Fixação dos Preços dos MedicamentosO Governo aprovou na passada Quinta-feira, dia 24 de Maio de 2012, em Conselho de Ministros, um diploma que atribui ao Infarmed a responsabilidade pela fixação dos preços de venda ao público dos medicamentos sujeitos a receita médica e dos não sujeitos a receita médica e comparticipados.
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EMA has published practical guidance on implementation of the new pharmacovigilance legislationThe document, published today, clarifies some practical considerations that pharmaceutical companies will need to take into account before and after the legislation starts to apply in July this year. It includes the agreed position of the European Union (EU) regulatory network, following discussions between the Agency, national regulatory authorities and the European Commission services. The document includes answers to frequently asked questions on the following topics: The Agency will update the question-and-answer document on a regular basis with questions received at qanda-pv-legislation@ema.europa.eu. The Agency cannot reply directly to questions submitted to this address.
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Alterações ao sistema de notificação de ruturas de stockFoi publicada a Deliberação n.º 050/CD/2012, de 12/04/2012, com o objetivo de melhorar a informação prestada a todos intervenientes do setor, e em especial aos profissionais de saúde, sobre as situações de rutura de stock. Esta Deliberação entrou em vigor no dia 22/05/2012 (data de publicação da Circular Informativa N.º 112/CD) e aplica-se a todos os medicamentos (sujeitos e não sujeitos a receita médica) e complementa a atual forma de notificação das ruturas de stock ou de cessação da comercialização. Para dar cumprimento à Deliberação, os titulares de autorização de introdução no mercado (AIM) têm que: Todas as situações de suspensão, cessação da comercialização, ruturas de stock transitórias e pedidos de revogação de AIM têm que ser classificadas pelos titulares de AIM, quanto ao seu impacto, em 3 níveis: 1. Reduzido Existem medicamentos iguais (mesma substância ativa, forma farmacêutica e dosagem) ao medicamento em causa; Nas situações classificadas como tendo umimpacto médio e elevado, o titular de AIM tem que enviar, por e-mail para ruptura.medicamentos@infarmed.pt, os seguintes dados: - Identificação do(s) substituto(s) terapêutico(s) e medidas necessárias para a sua substituição; Adicionalmente, para todas as situações classificadas como tendo um impacto elevado, os titulares têm ainda que enviar um plano de contingência para minimizar o impacto da ausência do fornecimento do medicamento. O Infarmed encontra-se a desenvolver uma nova ferramenta de notificação de ruturas de stock que permitirá a notificação de todos os medicamentos (incluindo os medicamentos não sujeitos a receita médica), do risco associado à rutura e inclusão dos elementos acima mencionados. Até que esta aplicação esteja disponível, as notificações devem continuar a ser efetuadas como até aqui, através da aplicação Rupturas de fornecimento de medicamentos (http://app.infarmed.pt/sgrt/listrstock.aspx). Os elementos constantes na Deliberação devem ser enviados para o e-mail ruptura.medicamentos@infarmed.pt.
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Comparticipação de medicamentosApresentações essenciais para a submissão de pedidos de comparticipação (maio de 2012)
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New e-learning courseThe European Medicines Agency has launched an e-learning course for marketing authorisation holders to support compliance with Article 57(2) on the submission of information on medicines, one of the key measures of the new pharmacovigilance legislation.
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Despacho nº 6716/2012Foi publicado o Despacho nº 6716/2012, do Ministério da Saúde, que estabelece regras específicas para a dispensa das terapêuticas com antirretrovíricos às pessoas que vivem com VIH/SIDA e adequada utilização do sistema SI.VIDA. read more >
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Produtos Cosméticos e de Higiene CorporalFoi publicada em Diário da República a Declaração de Retificação nº 24-A/2012, que vem corrigir algumas inexatidões presentes no DL nº 63/2012, de 15 de março, nomeadamente no seu anexo, nas referências ao termo zircónio e nas entradas nºs 208, 209 e 249. read more >
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Prescrição por DCIFoi publicada a Portaria nº 137-A/2012, de 11 de maio, do Ministério da Saúde, que regulamenta a Lei nº 11/2012, de 8 de março, estabelecendo o regime jurídico a que obedecem as regras de prescrição de medicamentos, os modelos de receita médica e as condições de dispensa de medicamentos, bem como definindo as obrigações de informação a prestar aos utentes.
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Article 57 (2) requirementsEuropean Medicines Agency publishes new versions of controlled vocabularies used to comply with Article 57 (2) requirements on submission of information on medicines.
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European Medicines AgencyThe Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency has approved its 100th herbal community monograph since the Committee began work in 2004. This is a significant achievement for the Committee and a key step in in supporting the harmonisation of procedures and provisions for herbal medicinal products within the European regulatory framework.
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ICH E2C (R2) guidelineComments invited on the ICH E2C (R2) guideline on periodic benefit-risk evaluation report
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Delegados de Informação MédicaCom vista a simplificar o processo de comunicação e registo dos Delegados de Informação Médica (DIM), o Infarmed disponibiliza uma nova versão de aplicação online no seu site.
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EURD list public consultationFeedback requested on the draft list of EU reference dates for periodic safety update reports in preparation for introduction of the new pharmacovigilance legislation.
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Dispositivos médicosFoi publicado o Regulamento (UE) Nº 207/2012 da Comissão, de 9 de março que estabelece as condições em que as instruções de utilização dos dispositivos médicos podem ser fornecidas em formato eletrónico (e-IDU), em alternativa ao formato em papel.
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Dossiê de AIMA guideline europeia HMA/EMA Guidance document on the identification of commercially confidential information and personal data within the structure of the Marketing Authorisation (MA) dossier - release of information after granting of a marketing authorisation, de que o Infarmed foi relator, foi aprovada no dia 9 de março pelos Chefes das Agências de Medicamentos da União Europeia e pela Agência Europeia de Medicamentos (EMA).
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Boas práticas CMDhCMDh BEST PRACTICE GUIDES FOR THE SUBMISSION AND PROCESSING OF VARIATIONS IN THE MUTUAL RECOGNITION PROCEDURE - Rev 16.
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Consulta públicaA nova legislação europeia de farmacovigilância (Diretiva 2010/84/UE do Parlamento Europeu e do Conselho de 15 de dezembro de 2010 e Regulamento (UE) n.º 1235/2010 do Parlamento Europeu e do Conselho de 15 de dezembro de 2010) foi publicada em dezembro de 2010.
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Despacho nº 4343/2012Foi publicado o Despacho nº 4343/2012, pelos Ministérios da Economia e do Emprego e da Saúde - Gabinetes dos Secretários de Estado do Empreendedorismo, Competitividade e Inovação e da Saúde, que aprova os preços de referência unitários dos grupos homogéneos, para vigorar no trimestre civil que se inicia em 1 de abril de 2012. read more >
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BiocidasFoi publicado o DL nº 72/2012, de 23 de Março, que transpõe para a ordem jurídica nacional as Diretivas n.os 2011/10/UE, 2011/11/UE, 2011/12/UE e 2011/13/UE, da Comissão, de 8 de fevereiro, com alteração da lista de substâncias ativas que podem ser incluídas em produtos biocidas, tendo em vista a proteção da saúde humana e animal, bem como a salvaguarda do ambiente.
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Contratos Públicos de AprovisionamentoFoi publicado o Despacho n.º 4225/2012 do Ministério da Saúde - Gabinete do Secretário de Estado da Saúde que revoga a obrigatoriedade de aquisição através dos Contratos Públicos de Aprovisionamento celebrados no âmbito do Concurso Público n.º 2010/3, para fornecimento de Corretivos da Volémia e outras Soluções Estéreis e no âmbito do Concurso Público n.º 2010/18, para fornecimento de Medicamentos do Consumo Geral e Outros. read more >
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Reconhecimento da avaliaçãoOs requerentes/titulares de Autorização de Introdução no Mercado (AIM) podem, mediante condições, requerer ao Infarmed que determinado medicamento beneficie da avaliação efetuada ou a efetuar para outro medicamento.
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Prescrição e dispensa de medicamentosForam publicados em Diário da República os seguintes novos diplomas legais:
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Legislação dos cosméticosO Decreto-Lei n.º 63/2012, de 15 de março, procede à terceira alteração ao Decreto-Lei n.º 189/2008, de 24 de setembro, que estabelece o regime jurídico dos produtos cosméticos e de higiene corporal, alterado pelos Decretos-Leis n.os 115/2009, de 18 de maio, e 113/2010, de 21 de outubro, transpondo para a ordem jurídica nacional a Diretiva n.º 2011/59/UE, da Comissão, de 13 de maio, que altera a Diretiva n.º 76/768/CEE, do Conselho, de 27 de julho, relativa aos produtos cosméticos, a fim de adaptar os seus anexos II e III aos progressos técnicos.
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Formulário eletrónico fase pilotoA Agência Europeia do Medicamento (EMA) lançou em fase piloto uma ferramenta eletrónica para ser utilizada em pedidos de AIM centralizados.
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Prescrição e dispensa de medicamentosA Lei nº 11/2012 hoje publicada vem estabelecer as novas regras de prescrição e dispensa de medicamentos, procedendo à sexta alteração ao regime jurídico dos medicamentos de uso humano, aprovado pelo DecretoLei n.º 176/2006, de 30 de agosto, e à segunda alteração à Lei n.º 14/2000, de 8 de agosto.
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Core Safety Profile (CSP)A Direção de Gestão do Risco de Medicamentos (DGRM) informa todos os titulares de AIM que o Infarmed passará a disponibilizar nova informação acerca do Core Safety Profile (CSP) que irá estar disponível em Página Inicial > Medicamentos Uso Humano > Farmacovigilância > Informação de Segurança > Core Safety Profile (CSP).
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Farmacopeia PortuguesaDeclaração de retificação nº 352/2012 Ministério da Saúde/INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I. P.
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PreçosFoi hoje publicada pelo Infarmed I.P. a circular informativa nº 056/CD sobre a notificação eletrónica dos preços dos medicamentos.
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Electronic Submission of Information on Medicinal Products for Human UseThis legal notice has been prepared and updated by the European Medicines Agency (hereafter referred to as the Agency) to comply with the requirements for the electronic submission of information on medicinal products for human use authorised in the Union as provided for in Article 57(2), second sub-paragraph of Regulation (EC) No 726/2004.
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Requisitos obrigatórios para cumprimento do artigo 57(2)A Agência Europeia do Medicamento (EMA) publicou um conjunto atualizado de requisitos obrigatórios para cumprimento pelos titulares de AIM do disposto artigo 57(2) da nova legislação da farmacovigilância. A informação obrigatória sobre os medicamentos de cada titular deverá ser submetida eletronicamente até 2 de Julho de 2012, podendo para tal as pequenas e médias empresas recorrer à ferramenta EVWEB disponibilizada pela EMA e que entrou hoje em fase de produção.
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Orgânica do INFAMED I.P.Na sequência da aprovação da Lei Orgânica do Ministério da Saúde, com base em modelos de organização mais reduzidos e com menos custos, torna -se necessário proceder à revisão da estrutura orgânica dos organismos sob a tutela ou superintendência do Ministro da Saúde, como é o caso do INFARMED Autoridade Nacional do Medicamento e Produtos de Saúde, I. P.
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EudraVigilanceO Infarmed I.P. emitiu hoje uma nota informativa para todos os titulares de AIM na sequência do comunicado da EMA que refere que o ambiente de produção do EudraVigilance estará indisponível a partir das 17:30h de 29/02/2012 até às 09:00h de 05/03/2012.
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Good pharmacovigilance practicesThe European Medicines Agency has released the first batch of modules on good pharmacovigilance practices (GVP) for public consultation until 18 April 2012.
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Pharmacovigilance legislationThe European Commission has published transitional arrangements for the new pharmacovigilance legislation in preparation for the coming into force of the legislation in July 2012. Of particular interest to marketing-authorisation applicants and holders, the document provides answers to both legal and practical questions on a range of topics including renewal of applications, pharmacovigilance system master files and risk management plans.
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FarmacovigilânciaA nova legislação europeia de farmacovigilância (Directiva 2010/84/UE do Parlamento Europeu e do Conselho de 15 de Dezembro de 2010 e Regulamento (UE) N.º 1235/2010 do Parlamento Europeu e do Conselho de 15 de Dezembro de 2010) foi publicada em dezembro de 2010.
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Materiais educacionais e DHPCAtualização das Instruções aos Requerentes Submissão de Materiais Educacionais e Comunicações Dirigidas aos Profissionais de Saúde
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Prescrição eletrónica de medicamentosFoi publicada em Diário da República a Portaria nº 46/2012, de 13 de fevereiro, do Ministério da Saúde, que procede à primeira alteração à Portaria nº 198/2011, de 18 de maio, que estabelece o regime jurídico a que obedecem as regras de prescrição eletrónica de medicamentos.
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Acesso a medicamentos em ambiente hospitalarAcesso a medicamentos fornecidos pelos serviços farmacêuticos dos hospitais do SNS, nomeadamente no âmbito dos regimes especiais de comparticipação
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Common European Submission Platform CESPPlataforma Comum de Submissão Europeia CESP
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Avaliação prévia de medicamentosAvaliação prévia de medicamentos sujeitos a receita médica para aquisição pelos hospitais do SNS
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MRP/DCP new applicationsThe Coordination Group for Mutual Recognition and Decentralized Procedures Human (CMDh) has released revision 3 of the cover letter template that should be used by applicants for initial applications submitted through MRP or DCP.
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Distribuição por grosso de medicamentosO Infarmed I.P. emitiu hoje a Circular Informativa nº 020/CD, destinada às Associações grossistas de medicamentos e às empresas distribuidores por grosso, sobre o novo modelo de autorização para o exercício da atividade de distribuição por grosso de medicamentos de uso humano.
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Technical validation of marketing authorisation applications for medicinesFrom 3 January 2012, the MRHA will be performing a technical validation of all new MAA eCTD submissions.
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Farmácias nos AçoresFoi hoje publicado em Diário da República o Decreto Regulamentar Regional nº 3/2012/A da Região Autónoma dos Açores Presidência do Governo.
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Preço Afixado na Embalagem dos MedicamentosRelativamente ao preço afixado nas embalagens dos medicamentos, o Infarmed vem esclarecer que:
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PIP breast implantsScientific Committee on Emerging and Newly Identified Health Risks - Request for a rapid scientific opinion on the safety of PIP breast implants
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Medicamentos veterináriosFoi publicado em Diário da República o Despacho nº 403/2012, do Ministério da Agricultura, do Mar, do Ambiente e do Ordenamento do Território Direcção Geral de Veterinária, que fixa as normas e procedimentos a que obedece a alteração da classificação dos medicamentos veterinários quanto à dispensa.
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Uso off-label de medicamentos e dispositivos médicosA Food and Drug Administration (FDA) publicou uma guidance sobre as informações prestadas pelas companhias farmacêuticas sobre o uso off-label de medicamentos e dispositivos médicos, nomeadamente em ambiente de redes sociais.
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Produtos cosméticosConforme divulgado na Circular Informativa n.º 098/CD de 01/06/2011 do Infarmed, a partir de 11 de janeiro de 2012, as pessoas responsáveis pela colocação de produtos cosméticos na União Europeia podem notificar os seus produtos no Portal de Notificação de Produtos Cosméticos (CPNP), que será disponibilizado pela Comissão Europeia.
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Implantes mamáriosO INFARMED, I.P., enquanto responsável pelo Sistema Nacional de Vigilância de Dispositivos Médicos, vem relembrar da necessidade da notificação dos incidentes com dispositivos médicos, ocorridos em território nacional, de forma a adequar a gestão do risco e a garantir os melhores níveis de segurança na sua utilização.
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Medicamentos genéricos
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Sistema de Preços de ReferênciaO Infarmed publicou a lista de grupos homogéneos que entram em vigor no próximo trimestre, de acordo com o estabelecido no n.º 1 do artigo 27.º do regime geral das comparticipações do Estado no preço dos medicamentos aprovado pelo Decreto-Lei n.º 48-A/2010, de 13 de Maio, na sua redação atual, introduzida pelo Decreto-Lei n.º 106-A/2010, de 1 de Outubro.
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Publicidade a medicamentosO Infarmed verificou que os Titulares de AIM, no preenchimento de notificações de peças publicitárias de medicamentos no Sistema de Gestão de Publicidade de Medicamentos (GPUB), continuam a não preencher e/ou não detalhar as informações relativas aos elementos de difusão da peça publicitária.
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Estado da comercialização dos medicamentosA base de dados Infomed, inclui um novo campo relativo ao estado de comercialização dos medicamentos. Este estado de comercialização resulta da comunicação que é feita pelos titulares da AIM e é essencial para todas as entidades envolvidas no circuito do medicamento.
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Directiva medicamentos falsificados
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Novos preços dos medicamentos
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Genéricos e litígios sobre direitos de propriedade industrial
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Directiva Falsificados
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Código Deontológico e Código de Conduta
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Submissões electrónicas no InfarmedA publicação da Deliberação nº 195/CD/2011 veio revogar a Deliberação 102/CD/2010, do Infarmed I.P.
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Farmacopeia PortuguesaA Comissão da Farmacopeia Portuguesa é uma comissão técnica especializada do INFARMED Autoridade Nacional do Medicamento e Produtos de Saúde, à qual compete, genericamente, elaborar, rever, actualizar e interpretar a Farmacopeia Portuguesa, bem como emitir parecer, sempre que solicitada, sobre os assuntos com esta conexos.
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Associações de antiasmáticos e/ou broncodilatadores
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Decreto-Lei nº 112/2011
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Comercialização de medicamentos comparticipadosÉ da responsabilidade dos Titulares de AIM / representantes locais notificar ao Infarmed o início, suspensão ou cessação da comercialização dos seus medicamentos de uso humano.
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Prescrição Electrónica de MedicamentosO Ministério da Saúde determina, no âmbito do regime da prescrição electrónica de medicamentos, para efeitos de comparticipação e monitorização da prescrição, que os dados relativos à identificação dos prescritores médicos, médicos dentistas e odontologistas, deverão ser objecto de actualização, nos termos do presente despacho, até ao dia 30 de Novembro de 2011.
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Revogação de Grupos HomogéneosO Infarmed revoga os Grupos Homogéneos GH0770 e GH0771 (salbutamol, solução para inalação por nebulização, 2.5 mg/2.5 ml, [1-20] unidades e salbutamol, solução para inalação por nebulização, 5 mg/2.5 ml, [1-20] unidades, respectivamente), devido à inexistência no mercado de medicamentos genéricos contendo a substância activa Salbutamol, solução para inalação por nebulização.
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Publicidade a medicamentosA presente circular constitui um aditamento à Circular Informativa nº 229/CD, publicada em 9/11/2011.
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Publicidade a medicamentosNo seguimento do Acórdão do Tribunal de Justiça de 5 de Maio de 2011, o Infarmed vem esclarecer que:
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Associações de antiasmáticos e/ou broncodilatadores
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Marcação de PVP nas embalagens de medicamentosA APIFARMA divulgou através da sua E-News o seguinte esclarecimento:
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Fornecimento de antissépticos, desinfectantes, medicamentos de consumo geral e outros
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Call experts 2011A Comissão Europeia está a convidar cientistas para se juntarem à estrutura de aconselhamento dos seus Comités Científicos e base de dados de peritos.
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Directiva 2010/84/UE - FarmacovigilânciaO jornal Oficial da União Europeia apresenta a Rectificação da Directiva 2010/84/UE do Parlamento Europeu e do Conselho, de 15 de Dezembro de 2010, que altera, no que diz respeito à farmacovigilância, a Directiva 2001/83/CE que estabelece um código comunitário relativo aos medicamentos para uso humano. read more >
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Genéricos com SildenafilO Infarmed foi notificado para divulgar junto dos distribuidores e farmácias a apreensão dos medicamentos genéricos Sildenafil Siltop e Sildenafil Farmoz, comprimido revestido por película, dosagens de 25 mg, 50 mg e 100 mg, importados, fabricados e armazenados pelas requeridas (Tecnimede - Sociedade Técnico-Medicinal, S.A. e a Farmoz - Sociedade Técnico Medicinal, S.A., respectivamente), assim como os que estejam disponíveis em farmácias.
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Comissão do programa do medicamento hospitalarO Despacho n.º 13378/2011 estabelece a criação de uma comissão do programa do medicamento hospitalar, no seguimento da criação do programa do medicamento hospitalar, a qual tem como objectivos a actualização do referido programa, o reforço da intervenção das comissões de farmácia e terapêutica, a avaliação de situações que impeçam a uniformização da codificação hospitalar e dar a conhecer estas mesmas situações.
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Rectificação ao Despacho nº 13015/2011No seguimento de algumas incongruências, quer na numeração, quer no preço de referência unitário de alguns grupos homogéneos, do anexo I do despacho nº 13015/2011, publicado no Diário da República, 2ª série, nº 188, de 29 de Setembro, pode encontrar-se, no Diário de República, 2ª série, nº 194, de 10 de Outubro, o referido anexo rectificado. read more >
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Combate a medicamentos contrafeitos e ilegaisEm Setembro, 81 países e 165 agências estiveram envolvidas no combate à venda de medicamentos contrafeitos e ilegais e no alerta aos perigos associados à compra destes medicamentos.
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Extensão ao Procedimento Nacional do Regulamento das AlteraçõesO Regulamento das Alterações (Regulamento CE nº 1234/2008, de 24 de Novembro de 2008) tem como objectivo facilitar o processo de submissão e avaliação das alterações aos termos de Autorização de Introdução no Mercado (AIM), sem prejuízo do nível de protecção da saúde pública.
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Novo Regime de formação do preço dos medicamentosDecorrente da aprovação em Conselho de Ministros, do novo regime de formação do preço dos medicamentos que procede: à revisão do actual sistema de referenciação de preços, por alteração dos países de referência; estabelece um novo preço máximo de venda ao público do primeiro medicamento genérico a introduzir no mercado e altera as margens de comercialização dos medicamentos, a Phagecon disponibiliza através da ferramenta de pesquisa de preços, BUSCAMED, a previsão dos novos Preços de Venda ou Público (PVP) e a previsão dos novos Preços de Venda ao Armazenista (PVA), calculados com base nas novas margens de comercialização. read more >
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Procedimentos de Transmissão Electrónica com o InfarmedO Infarmed I.P. disponibiliza online o procedimento de testes de transmissão electrónica de casos de RAM (Individual Case Safety Reports ICSR) bem como a respectiva documentação de suporte, a adoptar pelos titulares de AIM / promotores de Ensaios Clínicos. É também possível consultar o procedimento a seguir caso haja uma falha no sistema que impeça a transmissão de ICSR ao Infarmed. read more >
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Novo Sistema de Farmacovigilância
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Proposta de extensão do Regulamento (CE) nº 1234/2008 às alterações aos termos da AIM submetidas por procedimento puramente nacionalAs alterações aos termos da AIM submetidas por procedimento puramente nacional encontram-se excluídas do âmbito do Regulamento (CE) nº 1234/2008.
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Novas medidas sobre o Receituário ElectrónicoO Memorando de Entendimento sobre as Condicionalidades de Política Económica (MoU) exige o cumprimento de um conjunto de medidas, nomeadamente na área da saúde, a implementar até ao final do ano de 2011.
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Pedidos de Autorização de Utilização Especial de Medicamentos pelos Hospitais do SNSNo seguimento dos pedidos de autorização especial de medicamentos pelos Hospitais do SNS, o Infarmed tem sido confrontado com situações de fornecimento gratuito de medicamentos por parte da Indústria Farmacêutica.
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Rotulagem dos dispositivos médicos novas disposições sobre o endereço do fabricanteO Central Management Committee (CMC) emitiu uma decisão, a 07 de Junho de 2011, sobre o teor da informação que deve estar contida no endereço do fabricante de dispositivos médicos, e do seu mandatário, quando aplicável, que deve constar na rotulagem e nas instruções de utilização.
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Criação da comissão científica para as boas práticas clínicas.O Secretário de Estado Adjunto do Ministro da Saúde determinou a criação da comissão científica para as boas práticas clínicas, que ficará sob a tutela da DirecçãoGeral da Saúde.
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Listagem de dispositivos médicos para diagnóstico in vitroO INFARMED, I.P., publicou no seu site, uma listagem de dispositivos médicos para diagnóstico in vitro de testes rápidos para a detecção de HIV 1/ 2.
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Revisão do Regime Especial de Comparticipação de MedicamentosFoi publicada a Portaria nº 267-A/2011, de 15 de Setembro, que define as condições de inclusão de novos medicamentos no regime especial de comparticipação respectivo, quer se trate de medicamentos utilizados no tratamento de determinadas patologias ou por grupos especiais de utentes.
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Novos critérios de validação para submissão electrónicaA Agência Europeia do Medicamento (EMA) emitiu um comunicado a informar as empresas farmacêuticas, de que a partir de 1 de Setembro, entra em vigor uma nova versão dos critérios de validação para as aplicações electrónicas de medicamentos de uso humano.
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Medidas de Contenção de custos no Serviço Nacional de SaúdeOs Ministérios das Finanças e da Saúde fixam a meta de referência para a redução dos custos operacionais dos hospitais, centros hospitalares e unidades locais de saúde integrados no sector empresarial do Estado, para 2012, num valor inferior em 11 % ao de 2011, segundo o Despacho n.º 10783-A/2011 de 31 de Agosto de 2011.
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Documentos de Requisição de Meios Complementares de Diagnóstico e TerapêuticaO Ministério da Saúde Gabinete do Secretário de Estado da Saúde define o modelo das requisições electrónicas de meios complementares de diagnóstico e terapêutica e que o modelo de documento pré-impresso para efeitos de requisição manual passa a ser de utilização excepcional, segundo o Despacho n.º 10783-B/2011 de 31 de Agosto de 2011.
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Electronic submission of information on medicinesEuropean Medicines Agency provides update on electronic submission of information on medicines
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Novas Medidas de Redução da despesa na SaúdeMinistro da Saúde Paulo Macedo apresentou ontem perante a Comissão Parlamentar de Saúde novas medidas de redução da despesa relacionada com os medicamentos.
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Proposta de lei sobre litígios de direitos de propriedade industrial de medicamentosO Conselho de Ministros de 1 de Setembro aprovou uma proposta de lei que cria um regime de composição dos litígios emergentes de direitos de propriedade industrial quando estejam em causa medicamentos de referência e medicamentos genéricos.
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Governo facilita acesso aos medicamentos genéricosO Conselho de Ministros de 1 de Setembro aprovou uma proposta de lei que vai facilitar o acesso dos medicamentos genéricos ao mercado, contribuindo para o aumento da respectiva quota de mercado e consequente redução da factura em medicamentos.
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Regulatory and procedural guideline: Member states contact points for translations reviewMember states contact points for translations review
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Updated requirements from CMDh on electronic and paper submissions for MRP/DCP or National proceduresCMDh has released an updated version of the "Requirements on Electronic submissions (NeeS and eCTD) and paper documentation for New Applications within MRP, DCP or National procedures", document CMDh/085/2008/Rev8, version date July 2011.
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OMS publica nova Guideline para Armazenamento e Transporte de produtos farmacêuticos sensíveis ao tempo de transporte e temperatura.Em Outubro de 2010 o WHO Expert Committee on Specifications for Pharmaceutical Preparations reuniu em Geneva, o relatório técnico resultante foi submetido ao WHO Executive Board e é agora publicado a Guideline para Armazenamento e Transporte de produtos farmacêuticos sensíveis ao tempo de transporte e temperatura (TTSPPs).
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Importação de medicamentos para uso pessoalO INFARMED I.P. publicou a Circular Informativa nº 148/CD, de 29/07/2011, informando o público em geral sobre a legislação aplicável a propósito dos pedidos de importação de medicamentos para uso pessoal que assumem maior frequência em tempo de férias.
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Produtos para protecção solarO INFARMED I.P. publicou a Circular Informativa nº 134/CD, de 14/07/2011, informando o público em geral sobre a importância dos hábitos de protecção solar e alertando os operadores económicos para a necessidade de cumprirem com as disposições regulamentares relativas à rotulagem destes produtos e de apresentarem os seus produtos com toda a informação necessária para o consumidor, não negligenciando a importância da tradução de toda a informação obrigatória, em particular da categoria de eficácia de protecção solar que deve estar devidamente destacada na rotulagem. read more >
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Dificuldade de acesso a medicamentos nas farmáciasO INFARMED I.P. publicou a Circular Informativa nº 126/CD, de 07/07/2011, informando que tomou conhecimento das dificuldades no fornecimento de determinados medicamentos, por diversas farmácias, para os quais não foi reportada a sua ruptura de fornecimento do mercado pelo respectivo titular de AIM.
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Lei 46/2011 - Novos tribunais de competência especializadaCriação do tribunal de competência especializada para propriedade intelectual e do tribunal de competência especializada para a concorrência.
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Nimesulida - conclusão da revisão da relação benefício-riscoO INFARMED I.P. publicou a Circular Informativa nº 117/CD, de 24/06/2011, informando sobre a conclusão da revisão da relação benefício-risco dos medicamentos contendo nimesulida, cuja utilização fica restrita ao tratamento da dor aguda ou da dismenorreia primária.
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Indicação do PVP na rotulagem dos medicamentosDecorrente da publicação da Lei n.º 25/2011 que vem repor a obrigatoriedade de indicação do preço de venda ao público (PVP) na rotulagem dos medicamentos, foi publicada hoje pelo INFARMED, I.P. a Circular nº 114/CD, que visa clarificar a implementação da referida Lei através de regulamentação adicional.
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Actualização das Tabelas n.º 1 e 2 da Portaria n.º 1471/2004, de 21 de Dezembro.O INFARMED I.P. publicou a Circular Informativa nº 112/CD, de 21/06/2011, que procede à divulgação da Deliberação do Conselho Directivo nº 110/CD/2011.
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Lei nº 25/2011, de 16 de JunhoFoi publicada em Diário da República de 16/06/2011 a Lei nº 25/2011, de 16 de Junho, que estabelece a obrigatoriedade da indicação do preço de venda ao público (PVP) na rotulagem dos medicamentos e procede à quarta alteração ao DL nº 176/2006, de 30 de Agosto, e revoga o artigo 2º do DL nº 106-A/2010, de 1 de Outubro.
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Aquisição directa de medicamentosO INFARMED I.P. publicou a Circular Informativa nº 109/CD, de 15/06/2011, sobre a concessão de autorização de aquisição directa de medicamentos aos fabricantes, importadores ou distribuidores por grosso por parte das clínicas e consultórios dentários, clarificando o Ponto 4 da Deliberação 016/CD/2010, de 28 de Janeiro.
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Lei nº 26/2011, de 16 de JunhoFoi publicada em Diário da República de 16/06/2011 a Lei nº 26/2011, de 16 de Junho, que estabelece alterações ao regime de transferência de farmácias (primeira alteração ao DL nº 307/2007, de 31 de Agosto).
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Sistema de Preços de ReferênciaO INFARMED I.P. publicou a Circular Informativa nº 111/CD, de 15/06/2011, que actualiza o SPR na comparticipação de medicamentos pelo SNS válido para o 3º trimestre de 2011.
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Preços e menções nas embalagens dos medicamentos comparticipadosO INFARMED I.P. publicou a Circular Informativa nº 099/CD, de 02/06/2011, com actualização da informação sobre os preços e menções a constar nas embalagens dos medicamentos comparticipados.
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Produtos Cosméticos - Regulamento CE 1223/2009O INFARMED I.P. publicou a Circular Informativa nº 098/CD, de 01/06/2011, sobre a nova legislação dos Produtos Cosméticos, o Regulamento (CE) nº 1223/2009, providenciando esclarecimento sobre as disposições transitórias e derrogatórias e datas de entrada em vigor.
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Medicamento Parkadina (Amantadina) regressa ao mercadoO Gabinete de Imprensa do INFARMED I.P. divulgou hoje uma Nota Informativa sobre a ruptura de stock do medicamento Parkadina (Amantadina - 100 mg).
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Certificação da QualidadeÉ com enorme satisfação que a Phagecon anuncia aos seus Clientes, Fornecedores e Parceiros que no passado dia 25 de Março de 2011 foi-lhe concedida a CERTIFICAÇÃO pela NP EN ISO 9001:2008, no seguimento da auditoria efectuada pelo Organismo BUREAU VERITAS Certification que declarou que o Sistema de Gestão da Phagecon se encontra de acordo com os requisitos das normas de sistemas de gestão acima mencionadas.
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Portaria nº 198/2011, de 18 de MaioFoi publicada em Diário da República de 18/05/2011 a Portaria nº 198/2011 que estabelece o regime jurídico a que obedecem as regras de prescrição electrónica, bem como o regime transitório da receita manual de medicamentos, prevendo que até à desmaterialização integral do processo de prescrição electrónica, a receita electrónica é objecto de materialização, i.e., impressão da receita electrónica.
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Portaria nº 193/2011, de 13 de MaioFoi publicada em Diário da República de 13/05/2011 a Portaria nº 193/2011 que regula o procedimento de pagamento da comparticipação do Estado no preço de venda ao público dos medicamentos dispensados a beneficiários do Serviço Nacional de Saúde que não estejam abrangidos por nenhum subsistema ou que beneficiem de comparticipação em regime de complementaridade.
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EMA - Publicação de Perguntas e Respostas no âmbito do Anexo 11 - Sistemas ComputorizadosO Capítulo 4 Documentação das Boas Práticas de Fabrico, assim como o Anexo 11 Sistemas Computorizados, foram revistos a Janeiro de 2011 e a data limite para a sua implementação é 30 de Junho de 2011.
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Site móvel para Prontuáro TerapêuticoFoi publicada hoje a Circular Informativa nº 076/CD, de 09/05/2011, do INFARMED IP, divulgando ao público em geral que está disponível um novo site móvel para acesso via dispositivos móveis (telemóveis e tablets) ao Prontuário Terapêutico e ao Guia dos Medicamentos Genéricos e dos Preços de Referência.
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Medicamento para doença de ParkinsonO Gabinete de Imprensa do INFARMED I.P. divulgou hoje um Esclarecimento sobre a ruptura de stock do medicamento Parkadina (Amantadina - 100 mg) onde refere o seguinte:
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Desconto no preço dos medicamentosFoi hoje publicada a Circular Informativa nº 073/CD, de 28/04/2011, do INFARMED I.P., que esclarece as farmácias sobre o seguinte:
Para mais informações ou esclarecimentos adicionais, contacte o Departamento de Apoio ao Cliente da Phagecon. read more >
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Prática de preços diferentes dos oficialmente aprovadosFoi hoje publicada a Circular Informativa nº 071/CD, de 26/04/2011, do INFARMED I.P., que esclarece as farmácias e distribudores sobre o seguinte:
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Lei nº 10/2011Foi publicada em Diário da República a Lei nº 10/2011, de 21 de Abril, que estabelece o regime de dispensa gratuita de medicamentos após alta de internamento, pelos serviços farmacêuticos dos hospitais que integram o Serviço Nacional de Saúde (SNS), independentemente do seu estatuto jurídico.
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Fastum, 25mg/g, Gel Reintrodução no mercadoPor meio da Circular Informativa nº 63/CD, o INFARMED I.P. divulga que foi autorizada a reintrodução no mercado do medicamento Fastum, 25mg/g, Gel, na sequência da alteração da sua classificação quanto à dispensa para medicamento sujeito a receita médica (MSRM) e das alterações às secções relevantes do Resumo das Características do Medicamento (RCM), da Rotulagem e do Folheto Informativo (FI).
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Listagem de dispositivos médicos para diagnóstico in vitroNa sequência de vários pedidos de informação, provenientes de diversas Organizações e Instituições de Saúde, relativos aos vários testes rápidos disponíveis no mercado português para a detecção do vírus do HIV, o INFARMED I.P. refere que se tornou evidente a importância da existência de informação actualizada, que possibilite uma resposta imediata a solicitações relacionadas com este tipo de dispositivos.
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Documentos indispensáveis ao Distribuidor de Dispositivos MédicosO Infarmed publicou hoje a Circular Informativa nº 054/CD, de 31/03/2011, que visa estabelecer quais os documentos indispensáveis que um Distribuidor de Dispositivos Médicos deverá manter relativamente aos Dispositivos Médicos que distribui.
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Apresentações essenciais para a submissão de pedidos de comparticipaçãoO Infarmed publicou hoje a Circular Informativa nº 057/CD, de 31/03/2011, que visa tornar mais eficiente o processo de avaliação dos pedidos de comparticipação, pela disponibilização de uma base de dados que pretende ser uma orientação para os requerentes sobre quais as apresentações consideradas essenciais para o cumprimento do respectivo RCM, à luz do actual conhecimento, para a submissão de pedidos de comparticipação conformes.
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Decreto-Lei nº 47/2011 - Ministério da SaúdeFoi publicado hoje em Diário da República o Decreto-Lei nº 47/2011, de 31 de Março, do Ministério da Saúde, que altera a lista de substâncias activas que podem ser incluídas em produtos biocidas, tendo em vista a protecção da saúde humana e animal e a salvaguarda do ambiente, transpõe as Directivas n.os 2010/50/UE, de 10 de Agosto, 2010/51/UE, de 11 de Agosto, 2010/71/UE e 2010/72/UE, de 4 de Novembro, e 2010/74/UE, de 9 de Novembro, todas da Comissão, e procede à sétima alteração ao Decreto-Lei n.º 121/2002, de 3 de Maio.
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Despacho nº 5197/2011Foi publicado em Diário da Reública de 25/03/2011 o Despacho nº 5197/2011 conjunto dos Ministérios da Economia da Inovação e do Desenvolvimento e da Saúde, que aprova os preços de referência unitários dos grupos homogéneos, para vigorar no trimestre civil que se inicia em 1 de Abril de 2011, no âmbito do regime geral das comparticipações do Estado no preço dos medicamentos.
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Preços e menções a constar nas embalagens dos medicamentos comparticipados actualizaçãoPreços e menções a constar nas embalagens dos medicamentos comparticipados actualização
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Atorvastatina Farmoz - proibição de comercializaçãoFoi hoje publicada a Circular Informativa nº 50/CD, de 23/03/2011, do INFARMED I.P., que chama a atenção das Farmácias e Distribuidores para o seguinte:
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Portaria nº 112-B/2011, de 22 de MarçoFoi publicada em Diário da República a Portaria nº 112-B/2011, de 22 de Março, que estabelece o adiamento pelo período de 3 meses, automaticamente renovável por igual período, da revisão anual de preços do ano de 2011.
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Grupos homogéneos - rectificação da lista 2º Trimestre 2011O anexo da Deliberação n.º 045/CD/011, de 3 de Março de 2011, saiu com inexactidões relativamente à designação dos grupos homogéneos que integram a lista a vigorar no trimestre civil que se inicia em 1 de Abril de 2011. Por conseguinte, o Infarmed procede à divulgação da Deliberação do Conselho Directivo que aprova a lista rectificada dos Grupos Homogéneos, que entram em vigor no dia 1 de Abril de 2011.
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Despacho nº 4841/2011, de 18 de MarçoO Despacho do Ministério da Saúde agora publicado determina que a SPMS - Serviços Partilhados do Ministério da Saúde, E. P. E. (SPMS, E. P. E.), divulgue, através do Catálogo de Aprovisionamento Público da Saúde (Catálogo), no site www.catalogo.min-saude.pt, todas as características dos produtos abrangidos por contratos públicos de aprovisionamento (CPA), que estabelecem as condições de fornecimento de medicamentos anti-infecciosos. read more >
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Comunicação do horário de funcionamento da farmácia até 31 de MarçoConforme divulgado na Circular informativa n.º 002/CD de 12/01/2011, as farmácias têm, obrigatoriamente, que comunicar o horário de funcionamento para o 2.º semestre de 2011 até 31 de Março de 2011, mesmo que este não sofra alterações.
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Notificação electrónica dos preços dos medicamentosNotificação electrónica dos preços decorrente da publicação da Portaria n.º 312-A/2010, de 11 de Junho.
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Medicamentos ÓrfãosFoi publicada uma Nota Informativa do INFARMED I.P. sobre Medicamentos Órfãos, onde se afirma que o acesso dos doentes a este tipo de medicamentos está garantido.
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BUSCAMED - Directório Online de MedicamentosA Zeone Informática, Lda., PME que opera no segmento das tecnologias de informação e empresa parceira da Phagecon, face às inúmeras mudanças de preço verificadas no circuito nacional do medicamento, a retirada do preço das embalagens e alguma confusão gerada nos profissionais e no público em geral, decidiu dar o seu contributo, no âmbito da sua política de responsabilidade social, criando, com a consultoria e validação técnico-regulamentar da Phagecon, um Directório Online de Medicamentos - BUSCAMED - www.buscamed.com.pt, também disponível em versão adaptada a smartphones para que todos possam pesquisar o preço dos medicamentos, a qualquer momento e sempre que necessário.
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Revisão excepcional de preço dos medicamentosFoi hoje publicado o Despacho nº 2826/2011 dos Ministérios da Economia, da Inovação e do Desenvolvimento e da Saúde que define os critérios, prazos e demais procedimentos que presidem à revisão de preço dos medicamentos.
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Prescrição de medicamentosPresidente da República não promulgou diploma do Governo sobre prescrição de medicamentos
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Medicamentos Manipulados - comparticipaçãoFoi publicada a Circular informativa nº 007/CD de 21/01/2011 com a seguinte informação:
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Caducidade da comparticipação por não comercializaçãoFoi publicada a Circular informativa nº 015/CD de 02/02/2011 que determina o seguinte:
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Medicamentos - stocks mínimosFoi publicada a Circular informativa nº 014/CD de 31/01/2011 que anuncia a publicação da Deliberação nº 021/CD/2011 de 31 de Janeiro do Conselho Directivo do INFARMED I.P., que revoga a recente Deliberação nº 171/CD/2010, estabelecendo o seguinte:
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Medicamentos com Cetoprofeno - recolha temporária do mercado e passagem a MSRMFoi publicada a Deliberação nº 003/CD/2011 do Conselho Directivo do INFARMED I.P., que decidiu sobre a recolha temporária do mercado e passagem a MSRM de medicamentos contendo a substância activa Cetoprofeno - uso tópico.
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Despacho nº 1845/2011 do Ministério da SaúdeO despacho nº 20510/2008, de 24 de Julho, definiu as condições de dispensa e utilização de medicamentos prescritos a doentes com artrite reumatóide, espondilite anquilosante, artrite psoriática, artrite idiopática juvenil poliarticular e psoríase em placas.
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Publicação de novo Anexo 11 das BPF Sistemas ComputorizadosO anexo 11 do EU GMP Guide é o documento base que regulamenta os sistemas computorizados no âmbito das BPF. Durante muito tempo este documento não sofreu alterações, não reflectindo na totalidade os desenvolvimentos que ocorreram nesta área.
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Publicação do novo Capítulo 4 das BPF - DocumentaçãoEsta revisão surge na sequência da publicação em simultâneo do novo Anexo 11 Sistemas Computorizados, acrescentando no entanto outras alterações significativas.
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Criação de centros de investigação de ensaios clínicosFoi publicada em Diário da República a Resolução da Assembleia da República nº 2/2011 que recomenda ao Governo a criação de centros de investigação de ensaios clínicos, da seguinte forma:
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Pesquisa Medicamento - Informação directa ao CidadãoO Gabinete de Imprensa do INFARMED IP emitiu em 13-01-2011 uma nota informativa sobre a nova ferramenta de pesquisa de medicamentos disponível no sítio online da Autoridade. Destacam-se os seguintes pontos:
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Farmácia de oficina - comunicação do horário de funcionamentoFoi publicada a Circular Informativa nº 002/CD, de 12 /01/2011, do INFARMED I.P., que fornece esclarecimentos sobre a forma de comunicação do horário de funcionamento da farmácia de oficina - Ciclo de Vida da Farmácia e do Local de Venda de Medicamentos Não Sujeitos a Receita Médica - CIVIFAR/CIVILOC.
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Distribuidores por Grosso e Farmácias - Fornecimento de medicamentos: quantidades mínimas de stock e período de tempo para fornecimento aos utentes.O INFARMED I.P. no uso da sua competência regulamentar publicou a Deliberação n.º 171/CD/2010 que define os critérios de determinação das quantidades mínimas de medicamentos que devem ser mantidas permanentemente pelos distribuidores por grosso e o período de tempo que as farmácias deverão cumprir junto dos seus utentes para o fornecimento dos mesmos.
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Regulamentação do DL nº 7/2011, de 10 de JaneiroFoi publicada a Portaria nº 31-A/2011, de 11 de Janeiro que regulamenta o DL nº 7/2011, de 10 de Janeiro da seguinte forma:
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Período de abertura das farmácias - 24h/diaFoi publicado o Decreto-Lei nº 7/2011, de 10 de Janeiro que regula sobre o período de funcionamento das farmácias de oficina.
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Medicamentos comparticipados - preços e menções a constar nas embalagensCircular Informativa nº 225/CD, de 23/12/2010, do INFARMED I.P.
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Despacho nº 18694/2010 do Ministério da SaúdeFoi publicado o Despacho nº 18694/2010, de 16 de Dezembro, do Ministério da Saúde, que estabelece as condições de comparticipação de medicamentos manipulados e aprova a respectiva lista.
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Portal online das Farmácias (CIVIFAR)O INFARMED I.P. criou uma nova ferramente online para as Farmácias:
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Despacho nº 18419/2010 do Ministério da SaúdeFoi publicado o Despacho nº 18419/2010, de 13 de Dezembro, do Ministério da Saúde, que determina que os medicamentos destinados ao tratamento de doentes com artrite reumatóide, espondilite anquilosante, artrite psoriática, artrite idiopática juvenil poliarticular e psoríase em placas beneficiam de um regime especial de comparticipação.
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Amostras gratuitas de medicamentosTêm chegado ao conhecimento do INFARMED situações de fornecimento de amostras gratuitas de medicamentos por parte da Industria Farmacêutica aos Hospitais do Serviço Nacional de Saúde (SNS), enquanto ainda não existe decisão do pedido de avaliação prévia, nos termos do Decreto-Lei n.º 195/2006, de 3 de Outubro, para efeitos de aquisição do medicamento por esses hospitais. Como é sabido, na falta desta avaliação favorável, o medicamento não pode ser adquirido pelos Hospitais do SNS.
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Dispositivos Médicos - Certidão comprovativa de registo onlineAtendendo à obrigatoriedade de notificação das actividades de fabrico e distribuição por grosso de dispositivos médicos, o INFARMED IP alterou o procedimento de pedido de certidão comprovativa do registo de dispositivos médicos.
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Renovações de AIM - Alterações ao procedimento nacionalA 1 de Janeiro de 2011, o INFARMED I.P. vai implementar algumas novas medidas aplicáveis à verificação de conformidade dos pedidos de renovação de AIM por procedimento nacional.
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Utilização de medicamentos off-labelO INFARMED I.P. esclarece o seguinte:
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Escoamento embalagens medicamentos (Portaria nº 1041-A/2010, de 7 de Outubro)Contextualização
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Alterações Tipo II de Segurança - Actualização instruções INFARMED I.P.Foi publicada a Circular Informativa Nº 165/CD de 20/10/2010 do INFARMED I.P., que veio dar instruções aos Requerentes sobre a actualização do Manual de Submissão Electrónica de Alterações Tipo II de Segurança solicitadas pelo INFARMED I.P. em procedimentos nacionais.
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Grupos farmacoterapêuticos nos diferentes escalões de comparticipaçãoFoi publicada a Portaria nº 924-A/2010, de 17 de Setembro, do Ministério da Saúde, que veio regulamentar sobre os grupos e sub-grupos farmacoterapêuticos que integram os diferentes escalões de comparticipação.
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Política do Medicamento novas medidas aprovadas em Conselho de MinistrosNova Política do Medicamento medidas aprovadas em Conselho de Ministros
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Dispensa de medicamentos em unidose - Adesão pela farmáciaAs farmácias que pretendam proceder à dispensa de medicamentos em quantidade individualizada, têm que o solicitar ao Infarmed.
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Prazos de escoamento de medicamentos devido à alteração da taxa do IVA de 5% para 6%No âmbito da alteração da taxa de IVA e da simultânea revisão anual de preços o Infarmed informa que não é necessário efectuar a remarcação das embalagens de medicamentos cujo preço foi alterado, decorrente apenas da alteração da taxa de IVA e que já se encontravam no circuito de distribuição (distribuidores grossistas e farmácias) em 30 de Junho de 2010, para os medicamentos de marca, ou 31 de Julho de 2010, para os genéricos. Assim, o escoamento destes medicamentos pode ocorrer até ao final do prazo de validade, deixando de se considerar o prazo de 60 dias referido na Circular Informativa N.º 108/CD de 07/07/2010.
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Implementação do e-CTD em Portugal - Deliberação nº 102/CD/2010 do INFARMED I.P.Foi publicada a Deliberação nº 102/CD/2010, de 1 de Julho que regula a implementação do e-CTD em Portugal e esclarece sobre os procedimentos a adoptar para a fase transitória.
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Medicamentos Genéricos - Cálculo do PVP
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Medicamentos unidose nas farmáciasFoi publicada a Portaria n.º 455-A/2010, de 30 de Junho que regula a dispensa de medicamentos ao público, em quantidade individualizada, nas farmácias de oficina ou nas farmácias de dispensa de medicamentos ao público instaladas nos hospitais do Serviço Nacional de Saúde concessionadas ao abrigo do disposto no Decreto-Lei n.º 241/2009, de 16 de Dezembro, revogando a Portaria n.º 697/2009, de 1 de Julho. read more >
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Dispositivos médicos destinados ao controlo da diabetes Alteração da taxa do IVANo próximo dia 1 de Julho, haverá aumento da taxa do IVA, aplicável aos dispositivos médicos comparticipados destinados ao controlo da Diabetes, de 5% para 6%, com o consequente aumento do Preço de Venda ao Público (PVP).
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PVP dos medicamentos - procedimentos a adoptarMedicamentos genéricos - para obviar eventuais rupturas no abastecimento e evitar uma dupla marcação dos PVP no curto espaço de tempo de 1 mês, podem-se praticar PVP que, em resultado da nova taxa de IVA, são superiores aos que se encontram inscritos nas respectivas embalagens.
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Preço dos medicamentos - clarificação sobre as novas regras.Alteração à Portaria nº 312-A/2010, de 11 de Junho. Foi publicada a Portaria nº 337-A/2010, de 16 de Junho, que vem clarificar as dúvidas suscitadas a propósito do teor do nº1 do artigo 5º da Portaria nº 312-A/2010, de 11 de Junho.
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Preço dos medicamentos - notificação electrónica.Notificação electrónica dos preços decorrente da publicação da Portaria nº 312-A/2010, de 11 de Junho.
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Preço dos medicamentos - novas regras.Foi publicada a Portaria nº 312-A/2010, de 11 de Junho, que procede a um ajustamento da regulamentação, estabelecendo novas regras de formação dos preços dos medicamentos, sua alteração e revisão anual.
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Phagecon - Novo websiteEm destaque:
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Phagecon - Nova moradaO dia 1 de Abril de 2010 marca o ínicio de actividade da Phagecon em novas instalações: mais modernas, mais espaçosas e com melhores condições e acessos para os nossos colaboradores, clientes e parceiros. Todos os restantes contactos (telefone/fax/e-mail) se mantém inalterados.
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