# 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 67

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

A duly justified written statement on the suitability of the clinical trial sites adapted to the nature and use of the investigational medicinal product and including a description of the suitability of facilities, equipment, human resources and description of expertise, issued by the head of the clinic/institution at the clinical trial site or by some other responsible person, according to the system in the Member State concerned, shall be submitted.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/I/division/N/division/67 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-N/division-67
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.