rec_70

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance · European Union

(70) The authorisation procedure set out in this Regulation is largely controlled by Member States. Nevertheless, the Commission and the Agency should support the good functioning of that procedure, in accordance with this Regulation.

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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.