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anx_ANNEX__cpt_10__cpt_1__point_1__text_2

‘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”.’;

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