Article 54

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 an unexpected event is likely to seriously affect the benefit-risk balance, the sponsor and the investigator shall take appropriate urgent safety measures to protect the subjects. The sponsor shall notify the Member States concerned, through the EU portal, of the event and the measures taken. That notification shall be made without undue delay but no later than seven days from the date the measures have been taken. This Article is without prejudice to Chapters III and VII.

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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.