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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

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.