# 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), Article 15: General principles

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

A substantial modification, including the addition of a clinical trial site or the change of a principal investigator in the clinical trial site, may only be implemented if it has been approved in accordance with the procedure set out in this Chapter.

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Source: https://www.legislation.gov.uk/eur/2014/536/article/15 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/article-15
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.