1. — Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18…

1.

Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Four · European Union

Article 1(3) shall be replaced by the following: ‘3. The Commission shall adopt the principles relating to good clinical practice and detailed rules in line with those principles and shall, if necessary, revise those principles and detailed rules to take account of technical and scientific progress. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 21(3). The principles and detailed rules shall be published by the Commission.’;

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Source: EUR-Lex (Cellar) · retrieved 2026-10-21 · Text as adopted (Official Journal); later amendments are not incorporated in this text.