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40.—(1) A fee of £10,000 is payable by an applicant or holder of an authorisation, licence, certificate of registration, broker’s registration, active substance registration or sponsor or investigator who gives notice, under any of the provisions specified in paragraph (2), of their wish to—
(a)make further representations to the licensing authority or appear before or be heard by a person appointed, or
(b)propose that there should be a review upon oral representations.
(2) The specified provisions are—
(a)in the Human Medicines Regulations—
(i)regulation 27(3)(b) (procedure where licensing authority propose to suspend, revoke or vary licence);
(ii)paragraphs 11(1), 13(1)(a), 23(2) and 30(2) of Schedule 11 (advice and representations);
(iii)paragraph 3(8) of Schedule 32 (transitional provisions and savings in relation to product licences of right);
(b)in the Clinical Trials Regulations—
(i)paragraph 3(1)(a) of Schedule 5(1) (procedural provisions relating to the refusal or amendment of, or imposition of conditions relating to, clinical trial authorisations and the suspension or termination of clinical trails);
(ii)paragraph 4(1)(a) of Schedule 8(2) (procedural provisions relating proposals to grant, refuse to grant, vary, suspend or revoke manufacturing authorisations);
(c)provisions in Regulations allowing a representation, appearance, hearing or review in connection with a broker’s registration or active substance registration.
(3) The licensing authority will refund to that person—
(a)60% of that fee if the person withdraws the notice two weeks before the commencement of the hearing before the person appointed or the review upon oral representations;
(b)100% of that fee if, in respect of the hearing before the person appointed or the review upon oral representations, the decision notified by the licensing authority is—
(i)not to revoke, vary, suspend or terminate, as the case may be, the authorisation, licence or certificate of registration; or
(ii)to grant or renew, as the case may be, the authorisation, licence or certificate of registration.
41. The fee prescribed in regulation 40 is payable at the time the notice is given.
Schedule 5 was substituted by regulation 4 of, and paragraph 5 of Schedule 3 to, S.I. 2005/2754.
Paragraph 4 of Schedule 8 was substituted by regulation 4 of, and paragraph 6 of Schedule 3 to, S.I. 2005/2754.
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