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Regulatory and procedural guidelines (human and veterinary)
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Last updated 21 days ago
Checklist for the submission of Day 215 product information annexes for a post-opinion linguistic review (Word file)
21 days ago
Checklist for the submission of Day 215 product information annexes for a...
Classification of changes (tracked changes)
about 1 month ago
Classification of changes (tracked changes)
Procedural advice for veterinary vaccine antigen master file (VAMF) certification
about 1 month 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
about 1 month ago
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure...
Guide for rapporteurs and coordinators on the multinational assessment teams
3 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
3 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
4 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
4 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)
4 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)
4 months ago
EU Implementation Guide (IG) on veterinary medicines product data in the Union...