Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (c. 141)

1. Introductory Text

2. Article 1. Purpose

3. Article 2. Definitions

4. Article 3. Criteria for designation

5. Article 4. Committee for Orphan Medicinal Products

6. Article 5. Procedure for designation and removal from the register

7. Article 6. Protocol assistance

8. Article 7. Community marketing authorisation

9. Article 8. Market exclusivity

10. Article 9. Other incentives

11. Article 10. General report

12. Article 10a. (1) The Commission shall be assisted by the Standing Committee...

13. Article 10b. Exercise of the delegation

14. Article 11. Entry into force

15. Signature