Article 8

Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products · European Union

1. In order to facilitate the adoption of a common position by the Member States regarding marketing authorizations, a Committee for Proprietary Medicinal Products, hereinafter referred to as "the Committee", is hereby set up. The Committee shall consist of representatives of the Member States and of the Commission. 2. The responsibility of the Committee shall be to examine, in accordance with Articles 9 to 14, the questions referred to it by a Member State concerning the application of Articles 5, 11 or 20 of Directive 65/65/EEC. 3. The Committee shall draw up its own Rules of Procedure.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.