lexiara

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

Each Member State concerned shall assess, for its own territory, the application with respect to the following aspects: compliance with the requirements for informed consent as set out in Chapter V; compliance of the arrangements for rewarding or compensating subjects with the requirements set out in Chapter V and investigators; compliance of the arrangements for recruitment of subjects with the requirements set out in Chapter V; compliance with Directive 95/46/EC; compliance with Article 49; compliance with Article 50; compliance with Article 76; compliance with the applicable rules for the collection, storage and future use of biological samples of the subject. The assessment of the aspects referred to in the first subparagraph shall constitute Part II of the assessment report.

· All articles ·

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