Article 27

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 person responsible for marketing a proprietary medicinal product and, where appropriate, the holder of the authorization referred to in Article 16, furnish proof of the controls carried out on the finished product and/or the ingredients and of the controls carried out at an intermediate stage of the manufacturing process, in accordance with the methods laid down for the purposes of the marketing authorization.

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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.