The Veterinary Medicines Regulations 2013

PART 6U.K.General

Testing samplesU.K.

47.  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 certificatesE+W+S

48.—(1) The fee for an animal test certificate is [F1£1,170].

(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 [F2£40].

F3(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F4(4) The fee for an application for the variation of the certificate is—

(a)in the case of a small scale trial, £40; and

(b)in the case of any other trial, £390.]

[F5(5) The fee for an application to renew a certificate is—

(a)in the case of a small scale trial, £40; and

(b)in the case of any other trial, £190.]

(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).

Animal test certificatesN.I.

48.—(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 cascadeE+W+S

49.—(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—

F6(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)£30 if the veterinary medicinal product is authorised in [F7another] 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 treatment under the cascadeN.I.

49.—(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.

Wholesale dealer’s import certificateU.K.

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 [F8£760] .

(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 controlU.K.

[F951.  The fee for an authorisation to release a veterinary medicinal product under specific batch control is—

(a)£560; and

(b)£100 for each additional batch affected by the same issue where the specific batch control application is made at the same time.]

Submission of control tests of an immunological productU.K.

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

Export certificatesE+W+S

53.  The fee for an application for an export certificate is [F10£54] F11....

Export certificatesN.I.

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

Provision of adviceU.K.

54.  The fee for an application for written advice from the Secretary of State as to whether or not a product requires a marketing authorisation is £885.

[F12Provision of scientific adviceE+W+S

54A.  The fee for an application for written advice from the Secretary of State in relation to scientific matters is £4,487.]

Appeals to the Veterinary Products CommitteeU.K.

55.  The fee for an appeal to the Veterinary Products Committee is £1,500.

Fee relating to an appointed personU.K.

56.  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 F13... practice premisesE+W+S

57.—[F14(1) The fees for the inspection of a veterinary practice premises are set out in the following table—

(2) The initial registration and annual fee for the registration of veterinary practice premises with the Royal College of Veterinary Surgeons to supply veterinary medicinal products is [F15£38].

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

[F16(4) For the purposes of sub-paragraph (1) “mixed practice” means premises supplying veterinary medicinal products to livestock in addition to any other category mentioned in that provision.]

Fees relating to a veterinary surgeon’s practice premisesN.I.

57.—(1) The fee for the inspection of a veterinary surgeon’s practice premises is £350.

(2) The initial registration and annual fee for the registration of veterinary practice premises with the Royal College of Veterinary Surgeons to supply veterinary medicinal products is £34.

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

[F17Fee in relation to verifying destruction of controlled drugE+W+S

57A.  The fee for verifying the destruction of a controlled drug listed in Schedule 2, 3 or 4 to the Misuse of Drugs Regulations 2001 is—

(a)£142; or

(b)£31 (where the verification takes place during the course of an inspection for other purposes).]

[F17Pharmacovigilance inspectionsE+W+S

57B.—(1) In relation to a pharmacovigilance inspection the fee is—

(a)£3,600 in the case of a large marketing authorisation holder; and

(b)£1,650 in the case of a small marketing authorisation holder.

(2) In sub-paragraph (1)—

“large marketing authorisation holder” means a marketing authorisation holder who holds 30 or more marketing authorisations;

“small marketing authorisation holder” means a marketing authorisation holder who holds fewer than 30 marketing authorisations.]

Refund of fees relating to the Veterinary Products Committee or appointed personsU.K.

58.  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 noticeU.K.

59.  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 feesU.K.

60.  Where any fee [F18(other than any fee relating to a manufacturing authorisation or wholesale dealer’s authorisation)] is not paid, the Secretary of State may, after giving one month’s written warning, suspend the processing of any application from the person [F19or any authorisation held by the person] who has not paid the fee.

Waiver or reduction of feesU.K.

61.—(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.

[F20(1A) If the Secretary of State is satisfied that exceptional circumstances exist the Secretary of State may waive or reduce an inspection fee 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 withdrawnU.K.

62.—(1) Where an application for a marketing authorisation, or any variation referred to in paragraph 17 or 18 as a Type II variation, an extension, an extension-led grouped variation or a Type II led grouped variation 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.