rec_62

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

(62) In clinical trials compensation should be ensured for damages successfully claimed in accordance with the applicable laws. Therefore Member States should ensure that systems for compensation for damages suffered by a subject are in place which are appropriate to the nature and the extent of the risk.

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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.