What Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance) requires
This regulation establishes the centralised procedure for authorising medicinal products in the European Union, mandating its use for high-technology products (e.g., biotech-derived), orphan medicinal products, and new active substances…
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Pillar: Pharmaceuticals & Life Sciences · Authority: European Parliament and of the Council of the European Union · Version: 1.0.1 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32004R0726
SHA-256 integrity: fe81357b186e2217e915d07a1b0a41396f6ac01a760b11b3affda8051e927200
Primary Citations — 5 traced to source
- Regulation (EC) No 726/2004, Article 3(1) - Compulsory centralised procedure for high-technology medicinal products, particularly those derived from biotechnology
- Regulation (EC) No 726/2004, Article 3(1)(b) - Compulsory procedure for orphan medicinal products
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