# The Medicines (Products for Human Use) (Fees) Regulations 2016, Regulation 34: Fees for inspections relating to good clinical practice in clinical trials


A fee in accordance with paragraph 2 of Schedule 3 is payable by a person in respect of an inspection of one or more sites for the purpose of ascertaining whether that person—
(a) is—
(i) conducting, or has conducted, a clinical trial, or
(ii) performing, or has performed, the functions of a sponsor of a clinical trial (whether that person is the sponsor or is acting under arrangements made with that sponsor),
in accordance with good clinical practice, under regulation 28(1) (good clinical practice and protection of clinical trial subjects) of the Clinical Trials Regulations; or
(b) has put and kept in place arrangements for the purpose of ensuring that with regard to a clinical trial the requirements of good clinical practice are satisfied or adhered to, under regulation 28(2) of those Regulations.

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Source: https://www.legislation.gov.uk/uksi/2016/190/regulation/34 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-34
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.