A.INTRODUCTION AND GENERAL PRINCIPLESU.K.
1.Where a substantial modification concerns more than one clinical trial of the same sponsor and the same investigational medicinal product, the sponsor may make a single request for authorisation of the substantial modification. The cover letter shall contain a list of all clinical trials to which the application for substantial modification relates, with the EU trial numbers and respective modification code numbers of each of those clinical trials.U.K.
2.The application shall be signed by the sponsor or a representative of the sponsor. This signature shall confirm that the sponsor is satisfied that:U.K.
(a)
the information provided is complete;
(b)
the attached documents contain an accurate account of the information available; and
(c)
the clinical trial will be conducted in accordance with the amended documentation.