# 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 2: The application shall be signed by the sponsor or a representative of the sponsor. This signature shall confirm that the sponsor is satisfied that:

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

(a) the information provided is complete;
(b) the attached documents contain an accurate account of the information available; and
(c) the clinical trial will be conducted in accordance with the amended documentation.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/II/division/A/division/2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-II/division-A/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.