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Regulatory and procedural guidelines (human and veterinary)
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Last updated 4 days ago
Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications 2026-2027
6 days ago
Deadlines for submission of applications for orphan medicinal product designation to the...
Checklist for the submission of Day 215 product information annexes for a post-opinion linguistic review (Word file)
about 1 month ago
Checklist for the submission of Day 215 product information annexes for a...
Classification of changes (tracked changes)
about 2 months ago
Classification of changes (tracked changes)
Procedural advice for veterinary vaccine antigen master file (VAMF) certification
about 2 months 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 2 months 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
4 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
5 months ago
PRIME eligibility requests: 2026 deadlines for submission and timetable for assessment