Office of Public Sector Information

PART 3 Fees payable by manufacturers

Application for a manufacturing authorisation

27.  The fee for an application for a manufacturing authorisation for a veterinary medicinal product is—

(a) £2,740; or

(b) £500 if the authorisation only covers veterinary medicinal products manufactured under Schedule 6 (exemptions for small pet animals).

Application for a variation of a manufacturing authorisation

28.  The fee for an application to vary a manufacturing authorisation is—

(a) £490 if the variation requires scientific or pharmaceutical assessment,

(b) £345 if the variation only involves a change of ownership;

(c) £170 if the authorisation only covers veterinary medicinal products manufactured under Schedule 6 (exemptions for small pet animals); and

(d) otherwise £270.

Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascade

29.—(1) The fee for an application for a standard authorisation to manufacture an autogenous vaccine or a veterinary medicinal product for administration under the cascade is £3,110 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, or a single batch of veterinary medicinal product for administration under the cascade the fee is £1,555.

(3) The fee to vary an authorisation is £290 if no further inspection is required, and otherwise is the full application fee.

Annual fees

30.—(1) An annual fee of £435 is payable in respect of each manufacturing authorisation held (other than as specified in this paragraph).

(2) The annual fee for a manufacturing authorisation for an autogenous vaccine or a veterinary medicinal product for administration under the cascade is 0.67% of the turnover in the previous calendar year rounded up to the next £1, with a minimum fee of £10.

(3) There is no annual fee for a manufacturing authorisation for a veterinary medicinal product manufactured in accordance with Schedule 6 for small pet animals.

(4) In this paragraph “turnover”” means the gross value at manufacturers' prices of all authorised veterinary medicinal products sold or supplied in the United Kingdom.

Site inspections—type of site

31.  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

32.  The fees for the inspection of a site where immunological veterinary medicinal products are manufactured are in accordance with the following table.

Inspection of a site where sterile veterinary medicinal products are manufactured

33.  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.

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

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

Inspection of a site where veterinary medicinal products are assembled

35.  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.

Test sites

36.  The fee for the inspection of a test site is £2,800.

Animal blood bank authorisations

37.—(1) The fee for an authorisation to operate a blood bank is £3,110, with the same fee for each subsequent inspection.

(2) The fee for a variation is £290.