The Medicines for Human Use (Clinical Trials) Regulations 2004 No. 1031

SCHEDULE 3 U.K. PARTICULARS AND DOCUMENTS THAT MUST ACCOMPANY AN APPLICATION FOR AN ETHICS COMMITTEE OPINION, A REQUEST FOR AUTHORISATION, A NOTICE OF AMENDMENT AND A NOTIFICATION OF THE CONCLUSION OF A TRIAL

PART 2 U.K. REQUEST FOR AUTHORISATION

7.  The name and address of the person responsible for the manufacture or importation of any finished investigational medicinal product to be used in the trial and the details of any [F1 manufacturing authorisation or any] authorisation referred to in Article 13 of the Directive held by that person. U.K.

Textual Amendments

F1 Words in Sch. 3 Pt. 2 para. 7 inserted (31.12.2020) by S.I. 2019/744, reg. 24(3)(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 1 para. 8(a))