# 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 11

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

The cover letter shall indicate the location in the application dossier of the information necessary for assessing whether an adverse reaction is a suspected unexpected serious adverse reaction, that is the reference safety information.

---
Source: https://www.legislation.gov.uk/eur/2014/536/annex/I/division/B/division/11 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-B/division-11
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.