The Veterinary Medicines Regulations 2013

PART 3 U.K. Fees payable by manufacturers

Application for a manufacturing authorisation U.K.

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

(a) £3,040; or

(b) £530 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 U.K.

29.  The fee for an application for the variation of a manufacturing authorisation is—

(a) £636 if the variation requires scientific or pharmaceutical assessment;

(b) £443 if the variation only involves a change of ownership;

(c) £210 if the authorisation only covers veterinary medicinal products manufactured under Schedule 6 (exemptions for small pet animals); and

(d) otherwise £350.

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

30.—(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—

(a) £3,435 for a site in the United Kingdom;

(b) £3,270 for a site outside the United Kingdom.

(2) The fee for each inspection after a standard authorisation has been granted is (in each case) the same as the fee specified in paragraph (1).

(3) 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 £1,635.

(4) The fee to vary an authorisation is £305 if no further inspection is required, and otherwise is the full application fee.

Annual fees U.K.

31.—(1) An annual fee of £550 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 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 sales value at manufacturers’ prices net of value added tax of all authorised veterinary medicinal products sold or supplied in the United Kingdom.

Site inspections – type of site U.K.

32.  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 U.K.

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

Sites where immunological veterinary medicinal products are manufactured

Type of site	Fee (£)
	United Kingdom site	Site outside United Kingdom
Super site	24,071	22,867
Major site	16,785	15,946
Standard site	6,661	6,327
Minor site	4,757	4,519

Inspection of a site where sterile veterinary medicinal products are manufactured U.K.

34.  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 (£)
	United Kingdom site	Site outside the United Kingdom
Super site	23,324	22,157
Major site	13,010	12,359
Standard site	8,244	7,832
Minor site	5,022	4,770

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

35.  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 (£)
		United Kingdom site	Site outside the United Kingdom
Super site		14,180	13,471
Major site		8,325	7,909
Standard site		6,854	6,511
Minor site		3,789	3,600
If the site is only involved in the manufacture of veterinary medicinal products authorised under Schedule 6 (exemptions for small pet animals—
	Standard site	5,055	4,802
	Minor site	2,728	2,592

Inspection of a site where veterinary medicinal products are assembled U.K.

36.  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 (£)
	United Kingdom site	Site outside the United Kingdom
Super site	11,025	10,474
Major site	5,949	5,652
Standard site	4,917	4,671
Minor site	2,035	1,933

Test sites U.K.

37.  The fee for the inspection of a test site is £3,344, or £3,177 for a site outside the United Kingdom.

Animal blood bank or equine stem cell centre authorisations U.K.

38.—(1) The fee for an authorisation to operate a blood bank is—

(a) on a first inspection £3,113; and

(b) on each subsequent inspection—

(i) £3,113 for a site in the United Kingdom; and

(ii) £2,966 for a site outside the United Kingdom.

(2) The fee for an authorisation to operate an equine stem cell centre is £3,427, and £3,092 for each subsequent inspection.

(3) The fee for a variation to an authorisation to operate a blood-bank or equine stem cell centre is £320.