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Regulatory and procedural guidelines (human and veterinary)
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Last updated 1 day ago
Summary of changes to the ‘External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use’ - Version 1.5
1 day ago
Summary of changes to the ‘External guidance on the implementation of the...
External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use - Version 1.5
1 day ago
External guidance on the implementation of the European Medicines Agency policy on...
PMF dossier requirements - Questions and answers for PMF holders
2 days ago
PMF dossier requirements - Questions and answers for PMF holders
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2 - track changes
11 days ago
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO)...
Amended Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU recommendations for the seasonal influenza vaccine composition for the season 2025/2026
about 1 month ago
Amended Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting...
European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes
about 1 month ago
European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance...
Rules of procedure for the Patients and Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP)
about 1 month ago
Rules of procedure for the Patients and Consumers Working Party (PCWP) and...
Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU recommendations for the seasonal influenza vaccine composition for the season 2025/2026
about 2 months ago
Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU...
Procedural guidance to scientific committeesꞌ members and experts on completing the European Medicines Agencyꞌs declaration of interests in the Experts Management Tool
about 2 months ago
Procedural guidance to scientific committeesꞌ members and experts on completing the European...
European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008
about 2 months ago
European Medicines Agency procedural advice on recommendations on unforeseen variations according to...
Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in accordance with Article 62 (1) of Regulation (EC) No 726/2004
3 months ago
Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in...