The Veterinary Medicines Regulations 2009

PART 6 General

Testing samples

46.  The fee for testing a sample required to be submitted by the Secretary of State is the full economic cost of the test.

Animal test certificates

47.—(1) The fee for an animal test certificate is £345 in the case of—

(a) an immunological veterinary medicinal product that has been authorised in another member State for the species on which the proposed test will be conducted;

(b) a pharmaceutical veterinary medicinal product that has been authorised in another member State for use with a food-producing species on which the proposed test will be conducted where the same or similar dosage regime and method of administration is to be used in the medicinal test as is authorised; or

(c) a pharmaceutical veterinary medicinal product authorised in another member State for human or animal use where the test is to be conducted on companion animals only.

(2) The fee for an animal test certificate to administer medicinal products in a small scale trial to test them for clinical safety or efficacy is £30.

(3) In any other case the fee is £815.

(4) The fee for an application for a variation of the certificate is £265 for each change.

(5) The fee for an application to renew a certificate is £130.

(6) The Secretary of State may waive the fee if satisfied that the application is in relation to developing a veterinary medicinal product for a limited market (for example, for a minor species, a minor use, or for a disease with restricted regional distribution).

Importation of a veterinary medicinal product for treatment under the cascade

48.—(1) The fee for a certificate to import (if necessary) and be in possession of and administer a veterinary medicinal product under the cascade is—

(a) £15 if the veterinary medicinal product is authorised in another member State;

(b) £30 if the veterinary medicinal product is authorised in a third country.

(2) The fee is payable in respect of each animal treated, but in the case of administration to and treatment of a discrete group of animals, the Secretary of State may notify the applicant in writing that a fee for only one animal is payable.

(3) There is no fee if the application is made using the website of the Veterinary Medicines Directorate.

Importation of a veterinary medicinal product for administration under the Animals (Scientific Procedures) Act 1986

49.—(1) The fee for a certificate to import a product or substance for administration under a licence granted under the Animals (Scientific Procedure) Act 1986 is £15.

(2) There is no fee if the application is made using the website of the Veterinary Medicines Directorate.

Wholesale dealer’s import certificate

50.—(1) The fee payable by the holder of a wholesale dealer’s authorisation for a certificate to import and store a veterinary medicinal product not authorised in the United Kingdom to enable it to be supplied for administration under Schedule 4 is £750.

(2) The fee is only payable if, in the twelve month period immediately before the application, the applicant has supplied the veterinary medicinal product to which the certificate relates in accordance with at least 100 certificates.

Specific batch control

51.  The fee for an authorisation to release a veterinary medicinal product under specific batch control is—

(a) £560; or

(b) £455 for each batch if a number of specific batch control applications are made at the same time and all the batches are affected by the same issue.

Submission of control tests of an immunological product

52.  The fee for the submission of the results of tests carried out on a batch of immunological products prior to release is £80.

Export certificates

53.  The fee for an application for an export certificate is £30, and £15 for each certified copy.

Appeals to the Veterinary Products Committee: marketing authorisations and animal test certificates

54.  If the Secretary of State refuses to grant a marketing authorisation or an animal test certificate, or grants one that is different from what was applied for, the fee for an appeal to the Veterinary Products Committee is in accordance with the following table.

Application to the Veterinary Products Committee: authorisations and animal test certificates

Type of application	Fee(£)
Application involving a new active substance	1,940
Standard application	515
Application for a pharmacologically equivalent product	515
Application using identical data	205
Application for an animal test certificate	675

Appeals to the Veterinary Products Committee: variations

55.  If the holder of a marketing authorisation applies for a variation and the Secretary of State refuses it, the fee for an appeal to the Veterinary Products Committee is in accordance with the following table.

Appeal to the Veterinary Products Committee: variations

Type of application	Fee(£)
Type 1A variation	205
Type 1B variation	205
Type II variation	270

Appeal to the Veterinary Products Committee: suspensions

56.  The fee for an appeal to the Veterinary Products Committee following the suspension of a marketing authorisation or animal test certificate is £675.

Appeal to the Veterinary Products Committee: active substance under Schedule 6

57.  The fee for an appeal to the Veterinary Products Committee against the refusal or suspension of an approval of an active substance under Schedule 6 is £675.

Fee relating to an appointed person

58.  The appellant is liable for the full economic cost of a referral to an appointed person subject to a maximum of £5,000.

Fees relating to a veterinary surgeon’s practice premises

59.—(1) The fee for the inspection of a veterinary surgeon’s practice premises is £250.

(2) The annual fee for the registration of veterinary practice premises with the Royal College of Veterinary Surgeons to supply veterinary medicinal products is £40.

(3) Notwithstanding paragraph 2 of this Schedule, this is payable to the Royal College of Veterinary Surgeons.

Refund of fees relating to the Veterinary Products Committee or appointed persons

60.  The Secretary of State must refund the fee payable in relation to an appeal to the Veterinary Products Committee or to an appointed person if, as a result of the appeal, the Secretary of State changes the decision that was the subject of the appeal.

Fees relating to an improvement notice

61.  If an improvement notice is served under these Regulations, the fee for any subsequent inspection necessary as a result of the notice is the full economic cost of the inspection, payable by the person on whom the notice was served.

Non-payment of fees

62.  Where fees (other than fees relating to a manufacturing authorisation or wholesale dealer’s authorisation) are not paid, the Secretary of State may, after giving one month’s written warning, suspend the authorisation to which the fee relates.

Waiver or reduction of fees

63.—(1) If the Secretary of State is satisfied that for reasons of human or animal health or the protection of the environment it is desirable that a product should be authorised for veterinary use or that an authorised product should remain on the market the Secretary of State may waive or reduce any fees payable under these Regulations.

(2) An applicant or the holder of a marketing authorisation must provide full written justification for any waiver or reduction.

Reduction of fees when an application is withdrawn

64.—(1) Where an application for a marketing authorisation, a Type II variation or a variation referred to in paragraph 16(2) is withdrawn before determination, the fee is reduced in accordance with this paragraph.

(2) If no assessment (veterinary, scientific or pharmaceutical) has begun, the reduction is 90% .

(3) If assessment has begun but the Secretary of State has not yet requested further data, the reduction is 50% .

(4) If the Secretary of State has requested further information but it has not yet been provided, the reduction is 25% .

(5) If the further information requested has been supplied but has not yet been fully assessed or the application has not been referred to the Veterinary Products Committee, the reduction is 10% .

(6) Once the further information has been fully assessed, or the application has been referred to the Veterinary Products Committee, there is no reduction.