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Regulatory and procedural guidelines (human and veterinary)
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Latest posts
Last updated 8 days ago
Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with new Addendum II to Module VI on masking of personal data in individual case safety reports submitted to EudraVigilance
8 days ago
Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with...
Guideline on good pharmacovigilance practices (GVP) - Module VI Addendum II – Masking of personal data in individual case safety reports submitted to EudraVigilance
8 days ago
Guideline on good pharmacovigilance practices (GVP) - Module VI Addendum II –...
Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP)
9 days ago
Questions and answers (Q&As) on the external guidance of Policy 0070 on...
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 1 month ago
QRD guidance on the use of adopted abbreviations and pictograms on the...
Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse events in animals and humans - Rev.17
about 1 month ago
Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities...
List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animal and humans to veterinary medicinal products for 2025
about 1 month ago
List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA)...
Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products - Rev.16
about 1 month ago
Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms...
User guide of the HMA-EMA Catalogues of real-world data sources and studies
about 2 months 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
2 months 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
3 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
3 months ago
External guidance on the implementation of the European Medicines Agency policy on...
PMF dossier requirements - Questions and answers for PMF holders
3 months ago
PMF dossier requirements - Questions and answers for PMF holders