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Regulatory and procedural guidelines (human and veterinary)
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Latest posts
Last updated 23 days ago
Union procedure on the preparation, conduct and reporting of EU pharmacovigilance inspections
23 days ago
Procedural advice for orphan medicinal product designation: Guidance for sponsors
about 1 month ago
Procedural advice for orphan medicinal product designation: Guidance for sponsors
Connection template - EMA ESTRI Gateway using an AS2 compatible product
about 1 month ago
Connection template - EMA ESTRI Gateway using an AS2 compatible product
Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications - 2024-2025
about 1 month ago
Deadlines for submission of applications for orphan medicinal product designation to the...
Compilation of quality review of documents (QRD) on stylistic matters in product information
about 2 months ago
Compilation of quality review of documents (QRD) on stylistic matters in product...
Procedural advice on the accelerated assessment of marketing authorisation applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6
about 2 months ago
Procedural advice on the accelerated assessment of marketing authorisation applications pursuant to...
Questions and answers on the European Union framework for (traditional) herbal medicinal products, including those from a ‘non-European’ tradition
about 2 months ago
Questions and answers on the European Union framework for (traditional) herbal medicinal...
Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions (according to Regulation (EU) 2019/6)
2 months ago
Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions (according...