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 [F1manufacturing authorisation or any] authorisation referred to in Article 13 of the Directive held by that person.U.K.
Textual Amendments
F1Words 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))