# 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 52

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

The applicant may submit the version of the SmPC valid at the time of application, as the IMPD if the investigational medicinal product is authorised. The exact requirements are detailed in Table 1. Where new data are provided, it should be clearly identified.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/I/division/G/division/1.2/division/3/division/52 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.2/division-3/division-52
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.