Article 5

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: (a) the competent authorities verify that manufacturers and importers of products coming from third countries are able to carry out manufacture in compliance with the particulars supplied pursuant to point 4 of Article 4, second paragraph, of Directive 65/65/EEC and/or to carry out controls according to the methods described in the particulars accompanying the application in accordance with point 7 of Article 4, second paragraph, of that Directive; (1)See page 1 of this Official Journal. the competent authorities may allow manufacturers and importers of products coming from third countries, in exceptional and justifiable cases, to have certain stages of manufacture and/or certain of the controls referred to in (a) carried out by third parties ; in such cases, the verifications by the competent authorities shall also be made in the establishment designated.

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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.