# 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 53

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

If the investigational medicinal product is defined in the protocol in terms of active substance or ATC code (see above, paragraph 18), the applicant may replace the IMPD by one representative SmPC for each active substance/active substance pertaining to that ATC group. Alternatively, the applicant may provide a collated document containing information equivalent to that in the representative SmPCs for each active substance that could be used as an investigational medicinal product in the clinical trial.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/I/division/G/division/1.2/division/3/division/53 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.2/division-3/division-53
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.