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

3.

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

Non-clinical information submitted in an application dossier shall be based on data derived from studies complying with Union law on the principles of good laboratory practice, as applicable at the time of performance of those studies.

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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.