# The Medicines for Human Use (Clinical Trials) Regulations 2004, Regulation 22: Modifications by the sponsor


(1) A sponsor may make a modification to a clinical trial approval, other than a substantial modification, at any time and without the need for submitting a request under this regulation.
(2) A sponsor must—
(a) keep records of the modifications made in accordance with paragraph (1); and
(b) send those records to the licensing authority or the ethics committee, where the authority or committee (as the case may be) gives written notice requiring the sponsor to provide those records.
(3) If a sponsor makes a modification of an important detail, the sponsor must notify the authorities of the modification through an online portal made available for this purpose.
(4) If the sponsor proposes to make a substantial modification to a clinical trial approval which consists of, or includes, a substantial modification to—
(a) the terms of the request for approval of the clinical trial; or
(b) the particulars or documents that accompanied that request for approval,
the sponsor must submit a modification request to the authorities in accordance with paragraphs (6) and (7).
(5) Where the request for approval of the clinical trial was made under regulation 16(5), then a valid modification request must be submitted pursuant to paragraph (4) if the sponsor proposes to make a substantial modification to the clinical trial approval which consists of, or includes, a substantial modification to—
(a) the terms of the request for authorisation of the clinical trial;
(b) the application for an ethics committee opinion in relation to the trial; or
(c) the particulars or documents that accompanied—
(i) the request for authorisation, or
(ii) the application for an ethics committee opinion.
(6) A modification request must—
(a) be submitted to an online portal made available for this purpose;
(b) clearly identify the proposed substantial modification and whether it relates to the authorisation by the licensing authority or the ethics committee opinion;
(c) where the proposed substantial modification is a Route B substantial modification, include a statement confirming that it is a Route B substantial modification;
(d) be accompanied by—
(i) the particulars and documents specified in Part 3 of Schedule 3, and
(ii) any fee which may be payable in connection with that application under the Medicines (Products for Human Use) (Fees) Regulations 2016.
(7) The modification request and accompanying material in paragraph (6) must be supplied in English.
(8) The authorities must confirm whether the modification request is valid within the period of 7 days beginning with the date of the submission of the request and notify the sponsor accordingly.

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Source: https://www.legislation.gov.uk/uksi/2004/1031/regulation/22 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-22
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.