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Regulatory and procedural guidelines (human and veterinary)
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Last updated 8 days ago
Procedural advice for veterinary vaccine antigen master file (VAMF) certification
13 days ago
Procedural advice for veterinary vaccine antigen master file (VAMF) certification
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes
15 days ago
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure...
Guide for rapporteurs and coordinators on the multinational assessment teams
about 2 months ago
Guide for rapporteurs and coordinators on the multinational assessment teams
Scientific advice on MRL classification of chemical-unlike biological substances considered as not requiring an MRL evaluation according to Regulation (EU) 2018/782
2 months ago
Scientific advice on MRL classification of chemical-unlike biological substances considered as not...
Procedural advice on appointment and responsibilities of the CVMP rapporteur and co-rapporteur in accordance with Article 140(6) of Regulation (EU) 2019/6, and peer reviewer
3 months ago
Procedural advice on appointment and responsibilities of the CVMP rapporteur and co-rapporteur...
PRIME eligibility requests: 2026 deadlines for submission and timetable for assessment
3 months 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)
3 months 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)
3 months 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
5 months ago
Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with...