The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1989

PART II CAPITAL FEES FOR APPLICATIONS FOR LICENCES OR CERTIFICATES AND FOR INSPECTIONS IN CONNECTION THEREWITH

Applications for Licences

3.  Subject to regulations 22 and 24, 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 in connection with that application;

(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; and

(c) if appropriate, the fee prescribed in Part III of Schedule 1 in respect of samples submitted for testing at the request of the Licensing Authority in connection with that application.

Applications for Animal Test Certificates

4.  Subject to regulation 24, in connection with an application for an animal test certificate, there shall be payable by the applicant a fee of £2,500.

Applications for certificates for exports of medicinal products

5.—(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 £100; or

(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) “set of certificates” means the original certificate plus up to four certified copies of that certificate.