Article 1

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

Member States shall take all appropriate measures to ensure that the documents and particulars listed (1)OJ No 96, 2.6.1965, p. 1677/65. (2)OJ No 107, 19.6.1965, p. 1825/65. (3)OJ No 22, 9.2.1965, p. 369/65. in points 7 and 8 of Article 4, second paragraph, of Directive 65/65/EEC are drawn up by experts with the necessary technical or professional qualifications before they are submitted to the competent authorities. These documents and particulars shall be signed by the experts.

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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.