# 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 5: The modification shall be presented and described as follows:

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

(a) an extract from the documents to be amended showing previous and new wording in track changes, as well as an extract showing only the new wording, and a explanation of the changes; and
(b) notwithstanding point (a), if the changes are so widespread or far-reaching that they justify an entirely new version of the document, a new version of the entire document (in such cases, an additional table lists the amendments to the documents, whereby identical changes can be grouped).

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/II/division/D/division/5 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-II/division-D/division-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.