# 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 6: The following particulars shall appear on the immediate and the outer packaging:

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

(a) name of the main contact;
(b) name of the medicinal product, followed by its strength and pharmaceutical form;
(c) statement of the active substances expressed qualitatively and quantitatively per dosage unit;
(d) batch or code number identifying the contents and packaging operation;
(e) clinical trial reference code allowing identification of the clinical trial site, investigator and subject;
(f) directions for use (reference may be made to a leaflet or other explanatory document intended for the subject or person administering the product);
(g) ’For clinical trial use only’ or similar wording;
(h) the storage conditions; and
(i) period of use (expiry date or retest date as applicable).

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/VI/division/B/division/6 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-VI/division-B/division-6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.