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3. Subject to regulations 16 and 20 of these Regulations, in connection with an application for a product licence, a manufacturer’s licence or a wholesale dealer’s licence there shall be payable by the applicant –
(a)the fee prescribed in Part II of Schedule 1 to these Regulations in connection with that application; and
(b)in respect of any inspection of a description falling within paragraph 1 of Schedule 2 to these Regulations made in connection with that application the fee payable in accordance with paragraphs 2 to 5 of that Schedule.
4. Subject to regulation 20 of these Regulations, in connection with an application for a clinical trial certificate, there shall be payable by the applicant a fee of £8,000.
5.—(1) In connection with an application for a certificate issued under section 50 of the Medicines Act 1968, there shall be payable by the applicant —
(a)if the applicant requests that the certificate be issued within 24 hours of receipt of the application, a fee of £100;
(b)in any other case, a fee of £50; and
(c)in either case —
(i)a fee of £10 for each certified copy of the original certificate requested by the applicant in excess of four, and
(ii)a fee of £50 for each set of certificates requested by the applicant in addition to one.
(2) In paragraph (1)(c)(ii) above, “set of certificates” means the original certificate plus up to four certified copies of that certificate.
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