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)

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ANNEX II U.K. APPLICATION DOSSIER FOR SUBSTANTIAL MODIFICATION

B. COVER LETTER U.K.

3. A cover letter with the following information: U.K.

(a)

in its subject line, the EU trial number with the title of the clinical trial and the substantial modification code number which allows unique identification of the substantial modification, and which shall be used consistently throughout the application dossier;

(b)

identification of the applicant;

(c)

identification of the substantial modification (the sponsor's substantial modification code number and date), whereby the modification may refer to several changes in the protocol or scientific supporting documents;

(d)

a highlighted indication of any special issues relating to the modification and an indication as to where the relevant information or text is located in the original application dossier;

(e)

identification of any information not contained in the modification application form that might impact on the risk to subjects; and

(f)

where applicable, a list of all clinical trials which are substantially modified, with EU trial numbers and respective modification code numbers.