# 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 45

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

The test material used in toxicity studies shall be representative of that of the clinical trial use in terms of qualitative and quantitative impurity profiles. The preparation of the test material shall be subject to the controls necessary to ensure this and thus support the validity of the study.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/I/division/G/division/1.1/division/3/division/45 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.1/division-3/division-45
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.