art_20__para_8__text_1

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

Where the Member State concerned has not notified the sponsor of its decision within the periods set out in paragraphs 5 and 6, the substantial modification shall be deemed to be authorised in that Member State.

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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.