Opinion of the Advocate General — ECLI:EU:C:2004:419
Date: 2004-07-08
Language of the case: English
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: United Kingdom

Summary of the Judgment Approximation of laws – Medicinal products – Marketing authorisation – Hybrid abridged procedure – Reference medicinal product when considering application for authorisation – Right of competent authority to refer to the new pharmaceutical form of a product which has been authorised within the Community for at least 6 or 10 years (European Parliament and Council Directive 2001/83, Art. 10(1)(a)(iii)) An application for marketing authorisation for a Product C may be made under the hybrid abridged procedure established under Article 10(1)(a)(iii) of Directive 2001/83/EC on the Community code relating to medicinal products for human use where the application seeks to demonstrate that Product C is essentially similar to a Product B, in circumstances where Product B is a new pharmaceutical form of Product A, and Product A, but not Product B, has been authorised for marketing in the Community for at least the 6 or 10 year period stipulated therein. (see para. 30, operative part)