Fees payable by manufacturers
Updated 7 August 2025
Applies to England, Scotland and Wales
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1. Fee payable by manufacturers
1.1 Application for a manufacturing authorisation
A fee is payable in respect of each application for an authorisation to manufacture:
- an authorised veterinary medicine
- a product marketed under Schedule 6 of the Regulations (Exemptions for small pet animals)
- an extemporaneous preparation for treating an animal under the cascade
- an autogenous vaccine
- a blood product
- a stem cell product for non-food animals
Your manufacturing site will be inspected before authorisation is granted and an inspection fee will apply.
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-MANA1 | Manufacturing Authorisation: New application; all types | 28 | 拢762 |
1.2 Application for a variation of manufacturing authorisation
A fee is payable in respect of an application to vary a manufacturing authorisation relating to:
- an authorised veterinary medicine
- a product marketed under Schedule 6 of the Regulations (Exemptions for small pet animals)
- an extemporaneous preparation for treating an animal under the cascade
- an autogenous vaccine
- a blood product
- a stem cell product for non-food animals
There are two variation fees:
- one for a simple administration only
- another that requires scientific/pharmaceutical assessment by a GMP inspector. This may also require an inspection, for which an inspection fee will apply.
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-MANV1 | Manufacturing Authorisation: Variation; Scientific or pharmaceutical assessment | 29(a) | 拢684 |
| V23-MANV2 | Manufacturing Authorisation: Variation; Administration only | 29(b) | 拢105 |
1.3 Annual fee for manufacturing authorisations
Holders of a manufacturing authorisation relating to:
- an authorised veterinary medicine
- a product marketed under Schedule 6 of the Regulations (Exemptions for small pet animals)
- an extemporaneous preparation for treating an animal under the cascade
- an autogenous vaccine
- a blood product
- a stem cell product for non-food animals
are required to pay an annual fee to cover ongoing service costs.
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-MAAF1 | Annual fee for each manufacturing authorisation held | 31 | 拢575 |
1.4 Inspection of a site where an extemporaneous preparation for administration under the cascade is manufactured
Manufacturing sites are subject to a pre-authorisation inspection and thereafter regular risk-based inspections, for which a fee is payable.聽
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-ICS1A | Inspection for cascade Super Site: UK Site | 30(2) | 拢21,416 |
| V23-ICS1B | Inspection for cascade Super Site: Non-UK Site | 30(2) | 拢22,710 |
| V23-ICM1A | Inspection for cascade Major Site: UK Site | 30(2) | 拢12,850 |
| V23-ICM1B | Inspection for cascade Major Site: Non-UK Site | 30(2) | 拢14,144 |
| V23-ICT1A | Inspection for cascade Standard Site: UK Site | 30(2) | 拢6,425 |
| V23-ICT1B | Inspection for cascade Standard Site: Non-UK Site | 30(2) | 拢7,719 |
| V23-ICN1A | Inspection for cascade Minor Site: UK Site | 30(2) | 拢4,283 |
| V23-ICN1B | Inspection for cascade Minor Site: Non-UK Site | 30(2) | 拢5,577 |
1.5 Application and Assessment for an authorisation to manufacture an autogenous vaccine
A fee is payable in respect of each application for an authorisation to manufacture an autogenous vaccine. Your application will be scientifically assessed, and your manufacturing site will be inspected before the authorisation is granted. 聽The applicable inspection fee will apply
| Fee Code | Description | Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-AASA | Initial Scientific assessment of Autogenous Vaccine | 30A(1) | 拢6,962 |
1.6 Inspection of a site where an autogenous vaccine is manufactured
Manufacturing sites are subject to a pre-authorisation inspection and thereafter regular risk-based inspections, for which a fee is payable.聽
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-IVS1A | Inspection for Autogenous Vaccine: Super site UK | 30A(2) | 拢21,416 |
| V23-IVS1B | Inspection for Autogenous Vaccine: Super site Non-UK Site | 30A(2) | 拢22,710 |
| V23-IVM1A | Inspection for Autogenous Vaccine: Major site UK | 30A(2) | 拢12,850 |
| V23-IVM1B | Inspection for Autogenous Vaccine: Major site Non-UK site | 30A(2) | 拢14,144 |
| V23-IVT1A | Inspection for Autogenous Vaccine: Standard site UK | 30A(2) | 拢6,425 |
| V23-IVT1B | Inspection for Autogenous Vaccine: Standard Site Non-UK site | 30A(2) | 拢7,719 |
| V23-IVN1A | Inspection for Autogenous Vaccine: Minor site UK | 30A(2) | 拢4,283 |
| V23-IVN1B | Inspection for Autogenous Vaccine: Minor site Non-UK site | 30A(2) | 拢5,577 |
1.7 Assessment of a variation of an authorisation to manufacture an autogenous vaccine
A fee is payable in respect of an application to vary an autogenous vaccine. There are three fees:
- one for simple administration only variations
- another that requires scientific/pharmaceutical assessment
Depending on the nature of the changes being made, an inspection may also be required. The relevant inspection fee will apply.
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-AVCV1 | Variation: Complex; Scientific or Pharmaceutical Assessment | 30B(a) | 拢2,895 |
| V23-AVSV2 | Variation: Simple; Scientific or Pharmaceutical Assessment | 30B(b) | 拢885 |
| V23-AVAV3 | Variation: Administrative Scientific | 30B(c) | 拢455 |
1.8 Inspection of a site where an immunological veterinary medicine is manufactured
Manufacturing sites are subject to a pre-authorisation inspection and thereafter regular risk-based inspections, for which a fee is payable.聽
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-IIS1A | Inspection: Immunological Super site UK | 33 | 拢32,124 |
| V23-IIS1B | Inspection: Immunological Super site Non-UK | 33 | 拢33,418 |
| V23-IIM1A | Inspection: Immunological Major site UK | 33 | 拢21,416 |
| V23-IIM1B | Inspection: Immunological Major site Non-UK | 33 | 拢22,710 |
| V23-IIT1A | Inspection: Immunological Standard site UK | 33 | 拢10,708 |
| V23-IIT1B | Inspection: Immunological Standard site Non-UK | 33 | 拢12,002 |
| V23-IIN1A | Inspection: Immunological Minor site UK | 33 | 拢6,425 |
| V23-IIN1B | Inspection: Immunological Minor site Non-UK | 33 | 拢7,719 |
1.9 Inspection of site where a sterile veterinary medicine is manufactured
Manufacturing sites are subject to a pre-authorisation inspection and thereafter regular risk-based inspections, for which a fee is payable.聽
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-ISS1A | Inspection: Sterile Super site UK | 34 | 拢27,841 |
| V23-ISS1B | Inspection: Sterile Super site Non-UK | 34 | 拢29,135 |
| V23-ISM1A | Inspection: Sterile Major site UK | 34 | 拢19,274 |
| V23-ISM1B | Inspection: Sterile Major site Non-UK | 33 | 拢20,569 |
| V23-IST1A | Inspection: Sterile Standard site UK | 34 | 拢10,708 |
| V23-IST1B | Inspection: Sterile Standard site Non-UK | 34 | 拢12,002 |
| V23-ISN1A | Inspection: Sterile Minor site UK | 34 | 拢6,425 |
| V23-ISN1B | Inspection: Sterile Minor site Non-UK | 34 | 拢7,719 |
1.10 Inspection of site where no Immunological or Sterile veterinary medicines are manufactured
Manufacturing sites are subject to a pre-authorisation inspection and thereafter regular risk-based inspections, for which a fee is payable.聽
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-INS1A | Inspection: non-Immunological/non-Sterile Super site UK | 35 | 拢21,416 |
| V23-INS1B | Inspection: non-Immunological/non-Sterile Super site Non-UK | 35 | 拢22,710 |
| V23-INM1A | Inspection: non-Immunological/non-Sterile Major site UK | 35 | 拢12,850 |
| V23-INM1B | Inspection: non-Immunological/non-Sterile Major site Non-UK | 35 | 拢14,144 |
| V23-INT1A | Inspection: non-Immunological/non-Sterile Standard site UK | 35 | 拢8,566 |
| V23-INT1B | Inspection: non-Immunological/non-Sterile Standard site Non-UK | 35 | 拢9,861 |
| V23-INN1A | Inspection: non-Immunological/non-Sterile Minor site UK | 35 | 拢4,283 |
| V23-INN1B | Inspection: non-Immunological/non-Sterile Minor site Non-UK | 35 | 拢5,577 |
| V23-INT6A | Inspection: Sch 6 products Standard site UK | 35 | 拢3,212 |
| V23-INT6B | Inspection: Sch 6 products Standard site Non-UK | 35 | 拢4,507 |
| V23-INN6A | Inspection: Sch 6 products Minor site UK | 35 | 拢2,142 |
| V23-INN6B | Inspection: Sch 6 products Minor site Non-UK | 35 | 拢3,436 |
1.11 Inspection of a site where a veterinary medicine is assembled
Manufacturing sites are subject to a pre-authorisation inspection and thereafter regular risk-based inspections, for which a fee is payable.聽
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-IAS1A | Inspection: Assembly only; Super site UK | 36 | 拢17,133 |
| V23-IAS1B | Inspection: Assembly only; Super site Non-UK | 36 | 拢18,427 |
| V23-IAM1A | Inspection: Assembly only; Major site UK | 36 | 拢10,708 |
| V23-IAM1B | Inspection: Assembly only; Major site Non-UK | 36 | 拢12,002 |
| V23-IAT1A | Inspection: Assembly only; Standard site UK | 36 | 拢6,425 |
| V23-IAT1B | Inspection: Assembly only; Standard site Non-UK | 36 | 拢7,719 |
| V23-IAN1A | Inspection: Assembly only; Minor site UK | 36 | 拢4,283 |
| V23-IAN1B | Inspection: Assembly only; Minor site Non-UK | 36 | 拢5,577 |
1.12 Inspection of a site where a veterinary medicine is tested
Manufacturing test sites are subject to a pre-authorisation inspection and thereafter regular risk-based inspections, for which a fee is payable.聽
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-IT1A | Inspection fee: Test site UK | 37 | 拢3,212 |
| V23-IT1B | Inspection fee: Test site Non-UK | 37 | 拢4,507 |
1.13 Inspection of an authorised non-food animal blood bank or non-food animal stem cell centre
Manufacturing sites are subject to a pre-authorisation inspection and thereafter regular risk-based inspections, for which a fee is payable.聽
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-IBT1A | Inspection: Blood Bank UK | 38(1)a | 拢3,212 |
| V23-IBT1B | Inspection: Blood Bank Non-UK | 38(1)b | 拢4,507 |
| V23-IXT1A | Inspection: Stem cell product UK | 38(2)a | 拢2,142 |
| V23-IXT1B | Inspection: Stem cell product Non-UK | 38(2)b | 拢3,436 |