# 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), Division 9

Extent: E+W+S+N.I.

The cover letter shall indicate if the clinical trial is considered by the sponsor to be a low-intervention clinical trial and shall contain a detailed justification thereof.

---
Source: https://www.legislation.gov.uk/eur/2014/536/annex/I/division/B/division/9 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-B/division-9
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.