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

2.

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

The assessment report shall contain one of the following conclusions concerning the aspects addressed in Part I of the assessment report: the substantial modification is acceptable in view of the requirements set out in this Regulation; the substantial modification is acceptable in view of the requirements set out in this Regulation, but subject to compliance with specific conditions which shall be specifically listed in that conclusion; or the substantial modification is not acceptable in view of the requirements set out in this Regulation.

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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.