rec_47

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

(47) During a clinical trial, a sponsor may become aware of serious breaches of the rules for the conduct of that clinical trial. This should be reported to the Member States concerned in order for action to be taken by those Member States, where necessary.

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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.