The Medicines for Human Use (Clinical Trials) Regulations 2004

Clinical trials conducted in [F1 countries other than the United Kingdom] U.K.

21.—(1) If the licensing authority receives a valid request for authorisation relating to a clinical trial which is or is to be conducted in [F2 another] country as well as the United Kingdom, the licensing authority may, if they think fit, require the production by the sponsor of any one or more of the following—

(a) an undertaking, given by the sponsor, to permit their premises in that country to be inspected by or on behalf of the licensing authority for the purpose of establishing whether the conditions and principles of good clinical practice are satisfied or adhered to in relation to that trial; or

(b) an undertaking, given by the owner or occupier of any premises in that country at which the clinical trial is or is to be conducted, to permit those premises to be inspected by or on behalf of the licensing authority for the purpose of establishing whether the conditions and principles of good clinical practice are satisfied or adhered to in relation to that trial.

(2) If a sponsor fails to produce an undertaking required by the licensing authority in accordance with paragraph (1), that failure constitutes a ground for not accepting the request for authorisation, for the purposes of regulations 18 to 20.

Textual Amendments

F1 Words in reg. 21 heading substituted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 10(2); 2020 c. 1, Sch. 5 para. 1(1)

F2 Word in reg. 21(1) substituted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 10(3); 2020 c. 1, Sch. 5 para. 1(1)