Article 21

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. Member States shall take all appropriate measures to ensure that the holder of the authorization referred to in Article 16 has permanently and continuously at his disposal the services of at least one qualified person, in accordance with the conditions laid down in Article 23, responsible in particular for carrying out the duties specified in Article 22. 2. If he personally fulfils the conditions laid down in Article 23, the holder of the authorization may himself assume the responsibility referred to in paragraph 1.

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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.