# 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 46

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

Data from previous clinical trials and human experience shall be submitted in a logical structure, such as that of Module 5 of the ICH Common Technical Document format.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/I/division/G/division/1.1/division/4/division/46 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.1/division-4/division-46
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.