The Veterinary Medicines Regulations 2005

PART 4 Fees payable by manufacturers

Application for a manufacturing authorisation

22.  The fee for an application for a manufacturing authorisation for a veterinary medicinal product is £2,595.

Application for a variation of a manufacturing authorisation

23.  The fee for an application to vary a manufacturing authorisation is £465 where the variation requires scientific or pharmaceutical assessment, and £160 where it does not.

Application for an authorisation to manufacture an autogenous vaccine

24.—(1) An application for a standard authorisation to manufacture an autogenous vaccine is £2,960 for each manufacturing site, with the same fee for each subsequent inspection.

(2) In the case of an application for an individual authorisation to manufacture a single batch of autogenous vaccine, the fee is £1,480.

(3) The fee to vary an authorisation is £280 if no further inspection is required, and otherwise is the full application fee.

Annual fees

25.—(1) An annual fee of £240 is payable in respect of each manufacturing authorisation (other than a manufacturing authorisation in relation to an autogenous vaccine) held.

(2) The annual fee for a manufacturing authorisation for an autogenous vaccine is 0.67% of the turnover in the previous calendar year rounded up to the next £1, with a minimum fee of £10, and in this paragraph “turnover” has the meaning assigned in paragraph 39.

Site inspections – type of site

26.  For the purposes of deciding the fee for a site inspection—

• “super site” is a site at which 250 or more relevant persons are employed;

• “major site” is a site at which 60 or more, but fewer than 250, relevant persons are employed;

• “standard site” is a site at which 10 or more, but fewer than 60 relevant persons are employed;

• “minor site” is a site at which fewer than 10 relevant persons are employed;

• “relevant person” means a person employed on the premises and systems inspected.

Inspection of a site where immunological veterinary medicinal products are manufactured

27.  The following fees are payable for the inspection of a site where immunological veterinary medicinal products are manufactured—

Sites where immunological veterinary medicinal products are manufactured

Type of site	Fee (£)
Super site	24,015
Major site	16,900
Standard site	5,435
Minor site	4,745

Inspection of a site where sterile veterinary medicinal products are manufactured

28.  The following fees are payable for the inspection of a site where no immunological veterinary medicinal products are manufactured, but where sterile products are manufactured—

Sites where sterile veterinary medicinal products are manufactured

Type of site	Fee (£)
Super site	17,685
Major site	9,775
Standard site	4,805
Minor site	3,215

Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured

29.  The following fees are payable for the inspection of a site where only non-immunological and non-sterile veterinary medicinal products are manufactured—

Site where no immunological or sterile veterinary medicinal products are manufactured

Type of site	Fee (£)
Super site	10,660
Major site	5,610
Standard site	4,025
Minor site	2,170

Inspection of a site where veterinary medicinal products are assembled

30.  The following fees are payable for the inspection of a site where the only manufacturing process in relation to veterinary medicinal products is their assembly after the product has been put into its immediate container—

Site where medicinal products are assembled

Type of site	Fee (£)
Super site	7,750
Major site	5,235
Standard site	2,570
Minor site	1,325

Test sites

31.  The fee for the inspection of a test site is £2,665.

Animal blood bank authorisations

32.—(1) The fee for an authorisation to operate a blood bank is £2,960, with the same fee for each subsequent inspection.

(2) The fee for a variation is £280.

Expenses

33.  In addition the travel and subsistence costs of the inspectors, and any additional costs reasonably incurred by them (including, in the case of an inspection outside the United Kingdom, interpreters' fees) are payable.