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Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999
On orphan medicinal products
- Recitals
- Article 1 — Purpose
- Article 2 — Definitions
- Article 3 — Criteria for designation
- Article 4 — Committee for Orphan Medicinal Products
- Article 5 — Procedure for designation and removal from the register
- Article 6 — Protocol assistance
- Article 7 — Community marketing authorisation
- Article 8 — Market exclusivity
- Article 9 — Other incentives
- Article 10 — General report
- Article 10a
- Article 10b — Exercise of the delegation
- Article 11 — Entry into force
- Final