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art_6__continuation__2

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

Information and decisions under the first and second indents shall take into account the results of the clinical trials and pharmacological tests provided for in point 8 of Article 4, second paragraph, of Directive 65/65/EEC and in the case of the information referred to under the second indent, of experience acquired in use after marketing;

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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.