(1)

Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union (Text with EEA relevance) · European Union

in Article 8, paragraph 4 is replaced by the following: ‘4. The Commission is empowered to adopt delegated acts in accordance with Article 10b in order to supplement this Regulation by adopting the definitions of “similar medicinal product” and “clinical superiority”.’;

← anx_ANNEX__cpt_10__cpt_1__text_2 · All articles · anx_ANNEX__cpt_10__cpt_1__point_1__text_1 →

Source: EUR-Lex (Cellar) · retrieved 2026-10-13 · Text as adopted (Official Journal); later amendments are not incorporated in this text.