The Medicines for Human Use (Clinical Trials) Regulations 2004

8.—(1) The address of any premises at which any batch of finished investigational medicinal products to be used in the clinical trial has been, or is to be, checked in accordance with [F1 regulation 43(2) or] Article 13(3) of the Directive. U.K.

[F2 (2) If an investigational medicinal product to be used in the clinical trial has been, or is to be—

(a) imported into Great Britain from a country other than Northern Ireland or imported into Northern Ireland from a country other than an EEA State, a statement from the qualified person at the disposal of the person holding the manufacturing authorisation in relation to that importation specifying—

(i) the address of any premises outside the United Kingdom at which the product was manufactured or assembled; and

(ii) the manufacturing or assembling operations performed at those premises;

(b) imported into Northern Ireland from an EEA State, a statement from the qualified person at the disposal of the person holding the authorisation referred to in Article 13 of the Directive in relation to that importation specifying—

(i) the address of any premises outside the European Economic Area at which the product was manufactured or assembled; and

(ii) the manufacturing or assembling operations performed at those premises.]

Textual Amendments

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

F2 Sch. 3 Pt. 2 para. 8(2) substituted (31.12.2020) by S.I. 2019/744, reg. 24(3)(d)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 1 para. 8(c))