(2)

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

‘Clinical trial’ means a clinical study which fulfils any of the following conditions: the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned; the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.

← art_2__para_2__point_1__text_2 · All articles · art_2__para_2__point_2__text_1 →

Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.