# 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 41

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

The IMPD shall also contain summaries of non-clinical pharmacology and toxicology data for any investigational medicinal product used in the clinical trial in accordance with international guidance. It shall contain a reference list of studies conducted and appropriate literature references. Wherever appropriate, it is preferable to present data in tabular form accompanied by a brief narrative highlighting the main salient points. The summaries of the studies conducted shall allow an assessment of the adequacy of the study and whether the study has been conducted according to an acceptable protocol.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/I/division/G/division/1.1/division/3/division/41 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.1/division-3/division-41
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.