Fees payable by manufacturers
Published 16 May 2024
Applies to England, Scotland and Wales
© Crown copyright 2024
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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 | £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) | £684 |
| V23-MANV2 | Manufacturing Authorisation: Variation; Administration only | 29(b) | £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 | £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.
| 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) | £21,416 |
| V23-ICS1B | Inspection for cascade Super Site: Non-UK Site | 30(2) | £22,710 |
| V23-ICM1A | Inspection for cascade Major Site: UK Site | 30(2) | £12,850 |
| V23-ICM1B | Inspection for cascade Major Site: Non-UK Site | 30(2) | £14,144 |
| V23-ICT1A | Inspection for cascade Standard Site: UK Site | 30(2) | £6,425 |
| V23-ICT1B | Inspection for cascade Standard Site: Non-UK Site | 30(2) | £7,719 |
| V23-ICN1A | Inspection for cascade Minor Site: UK Site | 30(2) | £4,283 |
| V23-ICN1B | Inspection for cascade Minor Site: Non-UK Site | 30(2) | £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. 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) | £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.
| 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) | £21,416 |
| V23-IVS1B | Inspection for Autogenous Vaccine: Super site Non-UK Site | 30A(2) | £22,710 |
| V23-IVM1A | Inspection for Autogenous Vaccine: Major site UK | 30A(2) | £12,850 |
| V23-IVM1B | Inspection for Autogenous Vaccine: Major site Non-UK site | 30A(2) | £14,144 |
| V23-IVT1A | Inspection for Autogenous Vaccine: Standard site UK | 30A(2) | £6,425 |
| V23-IVT1B | Inspection for Autogenous Vaccine: Standard Site Non-UK site | 30A(2) | £7,719 |
| V23-IVN1A | Inspection for Autogenous Vaccine: Minor site UK | 30A(2) | £4,283 |
| V23-IVN1B | Inspection for Autogenous Vaccine: Minor site Non-UK site | 30A(2) | £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) | £2,895 |
| V23-AVSV2 | Variation: Simple; Scientific or Pharmaceutical Assessment | 30B(b) | £885 |
| V23-AVAV3 | Variation: Administrative Scientific | 30B(c) | £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.
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-IIS1A | Inspection: Immunological Super site UK | 33 | £32,124 |
| V23-IIS1B | Inspection: Immunological Super site Non-UK | 33 | £33,418 |
| V23-IIM1A | Inspection: Immunological Major site UK | 33 | £21,416 |
| V23-IIM1B | Inspection: Immunological Major site Non-UK | 33 | £22,710 |
| V23-IIT1A | Inspection: Immunological Standard site UK | 33 | £10,708 |
| V23-IIT1B | Inspection: Immunological Standard site Non-UK | 33 | £12,002 |
| V23-IIN1A | Inspection: Immunological Minor site UK | 33 | £6,425 |
| V23-IIN1B | Inspection: Immunological Minor site Non-UK | 33 | £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.
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-ISS1A | Inspection: Sterile Super site UK | 34 | £27,841 |
| V23-ISS1B | Inspection: Sterile Super site Non-UK | 34 | £29,135 |
| V23-ISM1A | Inspection: Sterile Major site UK | 34 | £19,274 |
| V23-ISM1B | Inspection: Sterile Major site Non-UK | 33 | £20,569 |
| V23-IST1A | Inspection: Sterile Standard site UK | 34 | £10,708 |
| V23-IST1B | Inspection: Sterile Standard site Non-UK | 34 | £12,002 |
| V23-ISN1A | Inspection: Sterile Minor site UK | 34 | £6,425 |
| V23-ISN1B | Inspection: Sterile Minor site Non-UK | 34 | £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.
| 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 | £21,416 |
| V23-INS1B | Inspection: non-Immunological/non-Sterile Super site Non-UK | 35 | £22,710 |
| V23-INM1A | Inspection: non-Immunological/non-Sterile Major site UK | 35 | £12,850 |
| V23-INM1B | Inspection: non-Immunological/non-Sterile Major site Non-UK | 35 | £14,144 |
| V23-INT1A | Inspection: non-Immunological/non-Sterile Standard site UK | 35 | £8,566 |
| V23-INT1B | Inspection: non-Immunological/non-Sterile Standard site Non-UK | 35 | £9,861 |
| V23-INN1A | Inspection: non-Immunological/non-Sterile Minor site UK | 35 | £4,283 |
| V23-INN1B | Inspection: non-Immunological/non-Sterile Minor site Non-UK | 35 | £5,577 |
| V23-INT6A | Inspection: Sch 6 products Standard site UK | 35 | £3,212 |
| V23-INT6B | Inspection: Sch 6 products Standard site Non-UK | 35 | £4,507 |
| V23-INN6A | Inspection: Sch 6 products Minor site UK | 35 | £2,142 |
| V23-INN6B | Inspection: Sch 6 products Minor site Non-UK | 35 | £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.
| 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 | £17,133 |
| V23-IAS1B | Inspection: Assembly only; Super site Non-UK | 36 | £18,427 |
| V23-IAM1A | Inspection: Assembly only; Major site UK | 36 | £10,708 |
| V23-IAM1B | Inspection: Assembly only; Major site Non-UK | 36 | £12,002 |
| V23-IAT1A | Inspection: Assembly only; Standard site UK | 36 | £6,425 |
| V23-IAT1B | Inspection: Assembly only; Standard site Non-UK | 36 | £7,719 |
| V23-IAN1A | Inspection: Assembly only; Minor site UK | 36 | £4,283 |
| V23-IAN1B | Inspection: Assembly only; Minor site Non-UK | 36 | £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.
| Fee Code | Description | GB VMR 2013 (as amended) Schedule 7 Para | Fee from 17/05/24 |
|---|---|---|---|
| V23-IT1A | Inspection fee: Test site UK | 37 | £3,212 |
| V23-IT1B | Inspection fee: Test site Non-UK | 37 | £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.
| 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 | £3,212 |
| V23-IBT1B | Inspection: Blood Bank Non-UK | 38(1)b | £4,507 |
| V23-IXT1A | Inspection: Stem cell product UK | 38(2)a | £2,142 |
| V23-IXT1B | Inspection: Stem cell product Non-UK | 38(2)b | £3,436 |