# 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 51

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

The applicant may either provide a stand-alone IMPD or cross-refer to the IB for the reference safety information and the summaries of pre-clinical and clinical parts of the IMPD. In the latter case, the summaries of pre-clinical information and clinical information shall include data, preferably in tables, providing sufficient detail to allow assessors to reach a decision on the potential toxicity of the investigational medicinal product and the safety of its use in the proposed clinical trial. If there is some special aspect of the pre-clinical data or clinical data that requires a detailed expert explanation or discussion beyond what would usually be included in the IB, the pre-clinical and clinical information shall be submitted as part of the IMPD.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/I/division/G/division/1.2/division/2/division/51 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.2/division-2/division-51
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.