anx_III__cpt_1__point_1__text_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 investigator does not need to actively monitor subjects for adverse events once the clinical trial has ended with regard to the subjects treated by him, unless otherwise provided for in the protocol.

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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.