The Veterinary Medicines Regulations 2006 No. 2407

SCHEDULE 7 U.K. FEES

PART 3 U.K. Fees payable by manufacturers

Application for a manufacturing authorisation U.K.

24.  The fee for an application for a manufacturing authorisation for a veterinary medicinal product is £2,660.

Commencement Information

I1 Sch. 7 para. 24 in force at 1.10.2006, see reg. 1

Application for a variation of a manufacturing authorisation U.K.

25.  The fee for an application to vary a manufacturing authorisation is £475 where the variation requires scientific or pharmaceutical assessment, and £165 where it does not.

Commencement Information

I2 Sch. 7 para. 25 in force at 1.10.2006, see reg. 1

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

26.—(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 £3,035 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 £1,515.

(3) The fee to vary an authorisation is £285 if no further inspection is required, and otherwise is the full application fee.

Commencement Information

I3 Sch. 7 para. 26 in force at 1.10.2006, see reg. 1

Annual fees U.K.

27.—(1) An annual fee of £245 is payable in respect of each manufacturing authorisation held (other than a manufacturing authorisation in relation to an autogenous vaccine or a veterinary medicinal product for administration under the cascade).

(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, and in this paragraph “turnover” has the meaning given in paragraph 21(4).

Commencement Information

I4 Sch. 7 para. 27 in force at 1.10.2006, see reg. 1

Site inspections—type of site U.K.

28.  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.

Commencement Information

I5 Sch. 7 para. 28 in force at 1.10.2006, see reg. 1

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

29.  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 (£)
Super site:	24,615
Major site:	17,325
Standard site:	5,570
Minor site:	4,865

Commencement Information

I6 Sch. 7 para. 29 in force at 1.10.2006, see reg. 1

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

30.  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:	18,125
Major site:	10,020
Standard site:	4,925
Minor site:	3,295

Commencement Information

I7 Sch. 7 para. 30 in force at 1.10.2006, see reg. 1

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

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

Sites where no sterile or immunological veterinary medicinal products are manufactured

Type of site	Fee (£)
Super site:	10,925
Major site:	5,750
Standard site:	4,125
Minor site:	2,225

Commencement Information

I8 Sch. 7 para. 31 in force at 1.10.2006, see reg. 1

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

32.  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:	7,945
Major site:	5,365
Standard site:	2,635
Minor site:	1,360

Commencement Information

I9 Sch. 7 para. 32 in force at 1.10.2006, see reg. 1

Test sites U.K.

33.  The fee for the inspection of a test site is £2,730.

Commencement Information

I10 Sch. 7 para. 33 in force at 1.10.2006, see reg. 1

Animal blood bank authorisations U.K.

34.—(1) The fee for an authorisation to operate a blood bank is £3,035, with the same fee for each subsequent inspection.

(2) The fee for a variation is £285.

Commencement Information

I11 Sch. 7 para. 34 in force at 1.10.2006, see reg. 1

Expenses U.K.

35.  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.

Commencement Information

I12 Sch. 7 para. 35 in force at 1.10.2006, see reg. 1