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Regulatory and procedural guidelines (human and veterinary)
Get the latest updates from Regulatory and procedural guidelines (human and veterinary) directly as they happen.
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Latest posts
Last updated 4 days ago
Question and answer on the information contained within section 5.1 of the summary of product characteristics on pharmacodynamic properties for pharmaceutical products
4 days ago
Question and answer on the information contained within section 5.1 of the...
Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026
5 days ago
Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026
Guidance for applicants for the preparation of the precise scope section of the variation application form
12 days ago
Guidance for applicants for the preparation of the precise scope section of...
Validation checklist for Type II quality variations
14 days ago
Validation checklist for Type II quality variations
Plasma Master File (PMF) requirements - questions and answers for PMF holders
20 days ago
Plasma Master File (PMF) requirements - questions and answers for PMF holders
Validation checklist for Type II (non) clinical variations
25 days ago
Validation checklist for Type II (non) clinical variations
Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications 2026-2027
about 1 month 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)
2 months ago
Checklist for the submission of Day 215 product information annexes for a...
Classification of changes (tracked changes)
3 months ago
Classification of changes (tracked changes)
Procedural advice for veterinary vaccine antigen master file (VAMF) certification
3 months ago
Procedural advice for veterinary vaccine antigen master file (VAMF) certification