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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

A person who, at the time when this Directive is brought into force, is engaged in direct collaboration with a person referred to in Article 21 in production supervision activities and/or in qualitative and quantitative analysis of active substances and the testing and checking necessary to ensure the quality of proprietary medicinal products may, for a period of five years after this Directive has been brought into force, be considered as qualified to take up in that State the duties of the person referred to in Article 21 provided that that Member State ensures that the person shows evidence of adequate theoretical and practical knowledge and has engaged in the activities mentioned for at least five years.

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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.