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Regulatory and procedural guidelines (human and veterinary)
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Last updated 8 days ago
PRIME eligibility requests: 2026 deadlines for submission and timetable for assessment
8 days ago
PRIME eligibility requests: 2026 deadlines for submission and timetable for assessment
EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 6: Examples for submission of legacy data (obsolete)
16 days ago
EU Implementation Guide (IG) on veterinary medicines product data in the Union...
EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 4: Process and format for the submission of legacy data on veterinary medicinal products (obsolete)
16 days ago
EU Implementation Guide (IG) on veterinary medicines product data in the Union...
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
about 2 months 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
about 2 months 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)
about 2 months 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
3 months 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
3 months 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
3 months 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
3 months 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
3 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
4 months ago
Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2025