# The Medicines for Human Use (Clinical Trials) Regulations 2004, Regulation 19: Clinical trials conducted in countries other than the United Kingdom


(1) If the licensing authority receives a request for authorisation which complies with regulations 14 and 16, relating to a clinical trial which is or is to be conducted in another country as well as the United Kingdom, the licensing authority may, if it thinks fit, require the production by the sponsor of either or both 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 in accordance with Schedule 1 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 approving the request for authorisation.

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Source: https://www.legislation.gov.uk/uksi/2004/1031/regulation/19 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-19
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.