PART 6General
Testing samples
45. 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
46.—(1) The fee for an animal test certificate is £340 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 £805.
(4) The fee for an application for a variation of the certificate is £260 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).
Treatment under the cascade
47. The fee for a certificate to import (if necessary) and be in possession of and administer a veterinary medicinal product authorised in another member State for treatment under the cascade is £15.
Treatment under the Animals (Scientific Procedures) Act 1986
48. 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.
Treatment in exceptional circumstances
49.—(1) The fee for a certificate to import (if necessary), be in possession of and administer a veterinary medicinal product authorised in a third country is £30 for the initial certificate and £30 for its renewal (£15 for a renewal if the certificate is renewed on-line using the website of the Veterinary Medicines Directorate) payable in respect of each animal treated.
(2) 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.
Specific batch control
50. The fee for an authorisation to release a veterinary medicinal product under specific batch control is—
(a)£550; or
(b)£450 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
51. 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
52. 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 ATCs
53. 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 | 1,910 |
| Standard application | 505 |
| Application for a pharmacologically equivalent product | 505 |
| Application using identical data | 200 |
| Application for an animal test certificate | 665 |
Appeals to the Veterinary Products Committee: variations
54. 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 | 200 |
| Type 1B variation | 200 |
| Type II variation | 265 |
Appeal to the Veterinary Products Committee: suspensions
55. The fee for an appeal to the Veterinary Products Committee following the suspension of a marketing authorisation or animal test certificate is £665.
Appeal to the Veterinary Products Committee: active substance under Schedule 6
56. 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 £665.
Fee relating to an appointed person
57. The appellant is liable for the full economic cost of a referral to an appointed person subject to a maximum of £5,000.
Fee for the inspection of a veterinary surgeon’s practice premises
58. The fee for the inspection of a veterinary surgeon’s practice premises is £250.
Refund of fees relating to the Veterinary Products Committee or appointed persons
59. 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
60. 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
61. 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
62.—(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
63.—(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.