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Regulatory and procedural guidelines (human and veterinary)
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Last updated about 16 hours ago
QRD guidance on the use of adopted abbreviations and pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised (DCP), subsequent recognition (SRP) and national procedures
about 16 hours ago
QRD guidance on the use of adopted abbreviations and pictograms on the...
User guide of the HMA-EMA Catalogues of real-world data sources and studies
20 days ago
User guide of the HMA-EMA Catalogues of real-world data sources and studies
Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2025
about 1 month ago
Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2025
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
about 2 months 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
about 2 months ago
External guidance on the implementation of the European Medicines Agency policy on...
PMF dossier requirements - Questions and answers for PMF holders
about 2 months 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
about 2 months 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
3 months 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
3 months 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)
3 months 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
3 months ago
Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU...