# 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 9: The particulars referred to in the following points shall not be omitted from the label of a product:

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

(a) paragraph 1, points (b), (c), (d), (f), (j) and (k);
(b) paragraph 4, points (b), (c), (e), and (f);
(c) paragraph 5, points (b), (c), (e), and (f);
(d) paragraph 6, points (b), (d), (e), (h), and (i).

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/VI/division/D/division/9 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-VI/division-D/division-9
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.