art_6__para_4

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use · European Union

4. Notwithstanding the provisions of this Article, a Member State may decide that the competent authority it has designated for the purpose of Article 9 shall be responsible for the consideration of, and the giving of an opinion on, the matters referred to in paragraph 3(h), (i) and (j) of this Article. When a Member State avails itself of this provision, it shall notify the Commission, the other Member States and the Agency.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-03 · Text as adopted (Official Journal); later amendments are not incorporated in this text.