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

G. INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER (IMPD) U.K.

1.1. Data relating to the investigational medicinal product U.K.

Introduction U.K.

37. Regarding data, the IMPD may be replaced by other documentation which may be submitted alone or with a simplified IMPD. The details of this ‘simplified IMPD’ are set out in section 1.2 ‘Simplified IMPD by referring to other documentation’. U.K.

38. Each section of the IMPD shall be prefaced with a detailed table of contents and a glossary of terms. U.K.

39. The information in the IMPD shall be concise. The IMPD must not be unnecessarily voluminous. It is preferable to present data in tabular form accompanied by a brief narrative highlighting the main salient points. U.K.