4. Subject to regulations 5, 19 and 23, in connection with an application for a product licence, a manufacturer’s licence, a wholesale dealer’s licence or a clinical trial certificate, there shall be payable by the applicant—
(a)the fee prescribed in Part II of Schedule 1 in connection with that application; and
(b)in respect of any inspection of a description falling within paragraph 1 of Schedule 2 made in connection with that application the fee payable in accordance with paragraphs 2 to 5 of that Schedule.
5. Where an inspection mentioned in regulation 4(b) is made at a site which has been named as a possible site for manufacture or assembly of a medicinal product by more than one applicant for—
(a)a product licence and that site is located outside the United Kingdom; or
(b)a manufacturer’s licence and that site is located in the United Kingdom,
the fee in respect of that inspection shall be payable in equal proportions by each applicant in connection with an application for such licence.
6.—(1) In connection with an application for a certificate issued under section 50 of the Act, 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 £150;
(b)in any other case, a fee of £75; and
(c)in either case—
(i)a fee of £75 for each set of certificates requested by the applicant in addition to one; and
(ii)a fee of £15 for each certified copy of the original certificate, not forming part of a set of certificates, requested by the applicant.
(2) In paragraph (1)(c)(i) above, “set of certificates” means an original certificate plus up to four certified copies of that certificate.