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

Fees

2.  Subject to paragraphs 3 to 5, the fee payable in respect of an inspection under these Regulations shall be–

(a) except in the case of an inspection falling within sub-paragraphs (b) to (d) below–

(i) in respect of a minor inspection, £750;

(ii) in respect of a standard inspection, £1,500;

(iii) in respect of a major inspection, £3,000;

(b) where the site inspected is wholly or partly concerned with the manufacture of sterile products or the filling of the containers directly in contact with such products–

(i) in respect of a minor inspection, £1,250;

(ii) in respect of a standard inspection, £2,500;

(iii) in respect of a major inspection, £5,000;

(c) except in the case of an inspection falling within sub-paragraph (b) above or sub-paragraph (d) below, where the site inspected is concerned only with the assembly of medicinal products–

(i) in respect of a minor inspection, £500;

(ii) in respect of a standard inspection, £1,000;

(iii) in respect of a major inspection, £2,000;

(d) where the site inspected is limited solely to the manufacture or assembly of–

(i) medicinal products, the sale or supply of which do not require a product licence and to which Article 2(2)(i)(e) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 applies; or

(ii) emergency vaccines for use in poultry or other animals;£50.

(e) For the purposes of sub-paragraph (d)(ii) “emergency vaccines” means (i) no other suitable licensed vaccines are readily available for such use and (ii) the vaccines are manufactured or assembled only from material obtained from the particular animal, flock or herd intended to be vaccinated.