Guidance

Fees payable by manufacturers

Updated 21 November 2024

Applies to England, Scotland and Wales

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