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

regulation 2(6).

SCHEDULE

“PART III FEES FOR APPLICATIONS FOR VARIATIONS OF LICENCES OR CERTIFICATES

Product licences

1.   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 £1,050;

(b) in any other case—

(i) requiring veterinary, scientific or pharmaceutical assessment–

(aa) for a variation, shall be £315;

(bb) for any other consequential variation to other licences, in identical terms, shall be £105;

(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £105 in respect of each variation;

(iii) where the variation applied for involves the reissue of the product licence in the new name of the company, shall be £105;

(iv) where the product licence relates solely to an emergency vaccine, shall be £30.

Manufacturers' licences

2.   The fee payable under regulation 5(a) in connection with an application for variation of a manufacturer’s licence—

(a) in the case of a manufacturer’s licence referred to in paragraph 5(2) of Part II of this Schedule, shall be £85;

(b) in any other case—

(i) requiring veterinary, scientific or pharmaceutical assessment, shall be £325;

(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £90.

Wholesale dealers' licences

3.   The fee payable under regulation 5(a) in connection with an application for variation of a wholesale dealer’s licence—

(a) requiring veterinary, scientific or pharmaceutical assessment, shall be £325;

(b) not requiring veterinary, scientific or pharmaceutical assessment, shall be £90.

Animal Test Certificates

4.   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;

(iii) where the variation applied for involves the reissue of the animal test certificate in the new name of the company, shall be £105; or

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

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

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

(iii) where the variation applied for involves the reissue of the animal test (confirmation of exemption) certificate in the new name of the company, shall be £85.”