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

3.

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 8(4) shall be replaced by the following: ‘4. The Commission shall adopt definitions of “similar medicinal product” and “clinical superiority” in the form of an implementing Regulation. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10a(3).’;

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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.