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) (c. 536)

ANNEX I U.K. APPLICATION DOSSIER FOR THE INITIAL APPLICATION

B. COVER LETTER U.K.

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

(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.