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Orphan Medicinal Products Regulation In force since 16 December 1999

Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products
32000R0141 · official text on EUR-Lex

This English text is a careful, terminology-researched translation prepared by eucite.com — not an official government translation. The German original linked above is the legally authoritative text.

Articles

• 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 11 — Entry into force