General
Published 16 May 2024
Applies to England, Scotland and Wales
© Crown copyright 2024
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This publication is available at https://www.gov.uk/government/publications/fees-applied-to-veterinary-medicine-authorisation-applications-in-gb/general
1. General
Fees applied which do not fall into the previous categories.
1.1 Testing samples
The fee for testing a sample required to be submitted by the Secretary of State is the full economic cost of the test.
1.2 Animal Test Certificate
An Animal Test Certificate (ATC) is required to carry out a clinical trial of a veterinary medicine in animals in the UK. A fee is required for an application, variation and renewal of an ATC.
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-ATC1 | Animal Test Certificate | 48(1) | £1,170 |
| V23-ATCS | Animal Test Certificate; small scale trial | 48(2) | £40 |
| V23-ATCSV | Variation of Animal Test Certificate; small scale trial | 48(4)a | £40 |
| V23-ATCOV | Variation of Animal Test Certificate; any other trial | 48(4)b | £390 |
| V23-ATCSR | Renewal of Animal Test Certificate; small scale | 48(5)a | £40 |
| V23-ATCOR | Renewal of Animal Test Certificate; any other trial | 48(5)b | £190 |
1.3 Wholesale Dealer Import Certificate (WDIC)
If you are a wholesale dealer and want to hold and supply imported medicines on request of a valid Special Import Certificate (SIC) holder, you will need a Wholesale Dealer Import Certificate. A fee applies if 100 or more SICs naming the importing wholesale dealer were issued in the last 12 months.
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-WDAIC | WDA Import Certificate Non-UK | 50(1) | £760 |
1.4 Specific Batch Control
You may apply for a Marketing Authorisation to release a veterinary medicine product under specific batch control and for each additional batch affected by the same issue where the specific batch control application is made at the same time.
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-BC10 | Specific Batch Control: release fee | 51(a) | £560 |
| V23-BC15 | Specific Batch Control: each additional batch affected | 51(b) | £100 |
1.5 Control tests of an immunological product
This fee applies to the submission of the results of tests carried out on a batch of immunological products other than autogenous vaccines prior to release.
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-BC81A | Submission: control tests | 7 | £80 |
1.6 Export certificates
Export certificates are issued upon request to certify that the product you are exporting:
- was manufactured in accordance with the UK marketing authorisation (MA), if there is one
- or if not, that the manufacturer holds a certificate of Good Manufacturing Practice
- or you hold a manufacturing authorisation (ManA) in the UK for that type of product
Different certificate types are available depending on the requirement of the exporter.
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-ECA1 | Export certificate | 53 | £54 |
1.7 Provision of advice
- Application for written advice on whether a product requires a marketing authorisation
- Application for a written advice in relation to scientific matters
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-ADV1 | Application for written advice | 54 | £885 |
| V23-ADVS1 | Written advice; scientific | 54A | £4,487 |
1.8 Appeals to the VPC
You can appeal against a decision, or the intention to make a decision, by the VMD acting on behalf of the Secretary of State, on any matter covered by the Veterinary Medicines Regulations (VMR).
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-VA30 | Appeal: Veterinary Products Committee | 55 | £1,500 |
| V23-VA99 | Referral to appointed person | 56 | £5,000 |
1.9 Fees relating to premises for retail supply by Suitably Qualified Persons (SQP)
You must hold an SQP retailer authorisation for a premises to retail supply veterinary medicinal products by SQPs. You will also be required to pay an annual fee.
We will inspect your premises on a risk basis, the inspection fee applied depends on the type of premises.
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-SQPAP | SQP retailer application for authorisation | 46(1)a | £105 |
| V23-SQPAN | SQP retailer annual fee | 46(2)a | £57 |
| V23-ISQPC | Inspection: SQP retailer; Companion animal medicine site | 46(1A) | £285 |
| V23-ISQPE | Inspection: SQP retailer; Equine medicine site | 46(1A) | £285 |
| V23-ISQPL | Inspection: SQP retailer; Livestock site | 46(1A) | £338 |
| V23-ISQPA | Inspection: SQP retailer; Avian site | 46(1A) | £285 |
1.10 Fees for Veterinary Surgeon’s Practice Premises (VPP)
If you have registered a VPP you must pay an annual fee to the RCVS as below and we will inspect your premises on a risk basis.
A mixed practice is a premises supplying medicines to livestock in addition to any other category listed.
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-VPRCV | Initial registration & fee payable to the RCVS | 57(2) | £38 |
| V23-IVPPC | Inspection: Companion animal VPP | 57(1) | £536 |
| V23-IVPPE | Inspection: Equine VPP | 57(1) | £536 |
| V23-IVPPL | Inspection: Livestock VPP | 57(1) | £536 |
| V23-IVPPM | Inspection: Mixed practice VPP | 57(1) | £698 |
| V23-IVPPO | Inspection: any other type of VPP | 57(1) | £451 |
| V23-DCDV1 | Witnessing controlled drug destruction; special visit | 57A(a) | £142 |
| V23-DCDI1 | Witnessing controlled drug destruction; during inspection | 57A(b) | £31 |
1.11 Pharmacovigilance Inspections
MAHs are subject to regular risk-based inspections of their pharmacovigilance systems, in this respect:
- ‘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
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-PILMA | Pharmacovigilance inspection: large MAH | 57B(1)a | £3,600 |
| V23-PISMA | Pharmacovigilance Inspection: small MAH | 57B(1)b | £1,650 |