# The Medicines (Products for Human Use) (Fees) Regulations 2016, Regulation 20: Fees for modifications to clinical trial authorisations


(1) A person who sends a modification request under regulation 22 (modifications by the sponsor) of the Clinical Trials Regulations relating to amendment of the protocol or the dossier related to a request for authorisation in accordance with paragraphs 2 or 5(a) of Part A1 of Schedule 3 (request for approval) to those Regulations must pay the fees mentioned in paragraph (2).
(2) The fees referred to in paragraph (1) are—
(a) the fee prescribed in paragraph 49 of Schedule 2 in connection with that amendment; and
(b) in respect of an inspection of a site made in connection with the application, the fee payable in accordance with regulations 30, 32, 33, 35 and 37.

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Source: https://www.legislation.gov.uk/uksi/2016/190/regulation/20 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-20
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.