5. — Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16…

5.

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 conclusion of the reporting Member State as regards the substantial modification of aspects covered by Part I of the assessment report is that the substantial modification is not acceptable, that conclusion shall be deemed to be the conclusion of the Member State concerned.

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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.