Regulation (EU) No 536/2014 of the European Parliament and of the CouncilShow full title

B. COVER LETTER U.K.

6. The cover letter shall specify the EU trial number and the universal trial number and shall draw attention to any features which are particular to the clinical trial. 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.

8. The cover letter shall indicate where the information listed in paragraph 7 is contained in the application dossier. U.K.

9. The cover letter shall indicate if the clinical trial is considered by the sponsor to be a low-intervention clinical trial and shall contain a detailed justification thereof. U.K.

10. The cover letter shall indicate if the methodology of the clinical trial requires that groups of subjects rather than individual subjects are allocated to receive different investigational medicinal products in a clinical trial, and as a consequence whether informed consent will be obtained by simplified means. U.K.

11. The cover letter shall indicate the location in the application dossier of the information necessary for assessing whether an adverse reaction is a suspected unexpected serious adverse reaction, that is the reference safety information. U.K.

12. In the case of a resubmission, the cover letter shall specify the EU trial number for the previous clinical trial application, highlight the changes as compared to the previous submission and, if applicable, specify how any unresolved issues in the first submission have been addressed. U.K.