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Regulatory and procedural guidelines (human and veterinary)
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Last updated about 1 month ago
Names of the European Union / European Economic Area countries
about 1 month ago
Names of the European Union / European Economic Area countries
Tables of non-standard abbreviations to be used in the summary of product characteristics
about 1 month ago
Tables of non-standard abbreviations to be used in the summary of product...
Mobile scanning and other technologies in the labelling and/or package leaflet of centrally authorised medicinal products
about 1 month ago
Mobile scanning and other technologies in the labelling and/or package leaflet of...
Question and answer on the information contained within section 5.1 of the summary of product characteristics on pharmacodynamic properties for pharmaceutical products
2 months 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
2 months 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
2 months ago
Guidance for applicants for the preparation of the precise scope section of...
Validation checklist for Type II quality variations
2 months ago
Validation checklist for Type II quality variations
Plasma Master File (PMF) requirements - questions and answers for PMF holders
3 months ago
Plasma Master File (PMF) requirements - questions and answers for PMF holders
Validation checklist for Type II (non) clinical variations
3 months 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
3 months 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)
4 months ago
Checklist for the submission of Day 215 product information annexes for a...