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

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

The qualified person shall ensure that each batch of investigational medicinal products manufactured in or imported into the Union complies with the requirements set out in Article 63 and shall certify that those requirements are fulfilled.

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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.