The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1991

PART III FEES FOR APPLICATIONS FOR VARIATIONS OF LICENCES OR CERTIFICATES

Product licences

1.  Subject to paragraph 5, the fee payable under regulation 5(a) in connection with an application for variation of a product licence—

(a) in the case of a complex application, shall be £1,075; and

(b) in any other case—

(i) requiring veterinary, scientific or pharmaceutical assessment—

(aa) for a variation, shall be £325;

(bb) for any other consequential variation to other licences, in identical terms shall be £110;

(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £110 in respect of each variation.

Manufacturers' licences

2.  Subject to paragraph 5, the fee payable under regulation 5(a) in connection with an application for variation of a manufacturer’s licence shall be—

(a) in the case of a manufacturer’s licence referred to in paragraph 4(2) of Part II of this Schedule, £90;

(b) in the case of a licence relating to an emergency vaccine, £85;

(c) in any other case, £325.

Wholesale dealers' licences

3.  Subject to paragraph 5, the fee payable under regulation 5(a) in connection with an application for variation of a wholesale dealer’s licence shall be £325.

Animal test certificates

4.  Subject to paragraph 5, the fee payable under regulation 5(a) in connection with an application for variation of—

(a) an animal test certificate—

(i) requiring veterinary, scientific or pharmaceutical assessment, shall be £315;

(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £105; or

(b) an animal test (confirmation of exemption) certificate—

(i) requiring veterinary, scientific or pharmaceutical assessment, shall he £300;

(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £85.

Other variations

5.  The fee payable under regulation 5(a) in connection with an application for variation of—

(a) a product licence, animal test certificate or animal test (confirmation of exemption) certificate where the variation applied for consists of a change to the licence or certificate not requiring veterinary, scientific or pharmaceutical assessment, shall be £110;

(b) a manufacturer’s licence or a wholesale dealer’s licence where the variation applied for consists of a change to the licence not requiring veterinary, scientific or pharmaceutical assessment, shall be £90;

(c) any licence or certificate issued under Part II of the Act where the variation applied for involves the reissue of the licence or certificate in the new name of the company, shall be £110;

(d) any licence relating solely to an emergency vaccine, £30.