# 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 7: However, in the cover letter it is not necessary to reproduce information already contained in the EU application form, with the following exceptions:

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

(a) specific features of the clinical trial population, such as subjects not able to give informed consent, minors and pregnant or breastfeeding women;
(b) whether the clinical trial involves the first administration of a new active substance to humans;
(c) whether scientific advice relating to the clinical trial or the investigational medicinal product has been given by the Agency, a Member State or a third country;
(d) whether the clinical trial is part or is intended to be part of a Paediatric Investigation Plan (PIP) as referred to in Title II, Chapter 3, of Regulation (EC) No 1901/2006 (if the Agency has already issued a decision on the PIP, the cover letter contains the link to the decision of the Agency on its website);
(e) whether investigational medicinal products or auxiliary medicinal products are a narcotic, psychotropic or radiopharmaceutical;
(f) whether the investigational medicinal products consist of or contain a genetically-modified organism or organisms;
(g) whether the sponsor has obtained an orphan designation for the investigational medicinal product for an orphan condition;
(h) a comprehensive list, including the regulatory status, of all investigational medicinal products and a list of all auxiliary medicinal products; and
(i) a list of medical devices which are to be investigated in the clinical trial but which are not part of the investigational medicinal product or products, together with a statement as to whether the medical devices are CE-marked for the intended use.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/I/division/B/division/7 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-B/division-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.