3.

A person who, at the time this Directive is brought into force, is engaged in direct collaboration with a person referred to in Article 29 in production supervision activities and/or in qualitative analysis, quantitative analysis of active principles, and the testing and checking necessary to ensure the quality of medicinal products may, for a period of five years thereafter, be considered as qualified to take up in that State the duties of the person referred to in Article 29, provided that the 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.