Guidance

Fees relating to Marketing Authorisations (MA)

Updated 21 November 2024

Applies to England, Scotland and Wales

1. Fees relating to Marketing Authorisations (MA)

1.1 MA for specific applications

The fee for an application for a marketing authorisation relating to:

  • Any biotechnical process involving recombinant DNA or the controlled expression of genes
  • A veterinary medicinal product containing a novel active ingredient
  • A biopharmaceutical product
Fee Code Description GB VMR 2013 (as amended) Schedule 7 Para Fee from 17/05/24
V23-SABAS Full complex application:  Novel/Recombinant DNA/Biopharm 7 £45,000

1.2 MA for pharmaceutical or immunological veterinary medicinal product

Fees relating to a full dossier, pharmaceutical, immunological or biological that is not immunological application under Part 1 of Schedule 1 or a bibliographic application for a pharmaceutical veterinary medicinal product; where all or parts of the data dossier are addressed using published data.

Fee Code Description GB VMR 2013 (as amended) Schedule 7 Para Fee from 17/05/24
V23-PIBFA Full application: Basic 7(a) £27,995
V23-PIB1A 1st additional strength Full Simultaneous Application 7(a) £4,590
V23-PIBSA Each subsequent additional strength 7(a) £1,465

1.3 Fee for a generic MA - generic application

Fees for a generic marketing authorisation; by referring to the safety and efficacy aspects of a data package submitted in support of an already authorised veterinary medicinal product, which is referred to as the reference product.

Fee Code Description GB VMR 2013 (as amended) Schedule 7 Para Fee from 17/05/24
V23-GNABH Generic Hybrid: Base fee 15A £13,950
V23-GNABN Generic Normal: Base fee 15A £12,390
V23-GNA1A 1st additional strength Simultaneous Application 15A £4,590
V23-GNASA Each subsequent additional strength 15A £1,465

The fee for applications using identical data submitted simultaneously or on the basis of informed consent; where you cross refer to safety and efficacy parts of the data package for an identical, already authorised product, which is referred to as the parent.

Fee Code Description GB VMR 2013 (as amended) Schedule 7 Para Fee from 17/05/24
V23-ICID Informed Consent Application 11 £1,465
V23-J7010 Identical Data Application 11 £1,465

1.5 Fees for exceptional MA for a pharmaceutical product

Fees for an exceptional provisional or limited pharmaceutical MA, where there is no other product with a full UK marketing authorisation, and it is based on provisional or limited data.

Pharmaceutical Provisional Marketing Authorisation

Fee Code Description GB VMR 2013 (as amended) Schedule 7 Para Fee from 17/05/24
V23-J1130 Exceptional Provisional Pharmaceutical: Base Fee 12 £12,015
V23-K1080 Exceptional Provisional Pharmaceutical: Food producing 12 £3,905
V23-K1090 Additional fee for each active ingredient not previously authorised for Food producing animals in UK 12 £5,850
V23-K1100 Additional fee for each active ingredient not previously authorised for Non-food producing animals in UK 12 £4,910
V23-K1150 Fee for each additional pack type 12 £710
V23-K1160 Additional fee for each active ingredient; Food producing 12 £5,955
V23-K1170 Additional fee for each active ingredient; Non-food producing 12 £3,800
V23-K1180 Additional fee for each additional Food producing species 12 £2,965
V23-K1190 Additional fee for each additional Non-food producing species 12 £1,485
V23-K1210 Additional fee for each additional recommended route of administration; Food producing 12 £2,185
V23-K1220 Additional fee for each additional recommended route of administration; Non-food producing 12 £710
V23-K1110 Simultaneous applications; fee for each additional product in the application 12 £2,895
V23-K2090 Additional fee for each active ingredient not previously authorised for Food producing animals in UK 12 £3,732
V23-K2100 Additional fee for each active ingredient not previously authorised for Non-food producing animals in UK 12 £3,262
V23-K2150 Fee for each additional pack type 12 £370
V23-K2160 Additional fee for each active ingredient; Food producing 12 £3,232
V23-K2170 Additional fee for each active ingredient; Non-food producing 12 £2,155
V23-K2180 Additional fee for each additional Food producing species 12 £1,985
V23-K2190 Additional fee for each additional Non-food producing species 12 £1,247
V23-K2210 Additional fee for each additional recommended route of administration; Food producing 12 £1,347
V23-K2220 Additional fee for each additional recommended route of administration; Non-food producing 12 £608
V23-K2110 Simultaneous applications; fee for each additional product in the application 12 £1,447

Fee for Pharmaceutical Limited MA

Fee Code Description GB VMR 2013 (as amended) Schedule 7 Para Fee from 17/05/24
V23-J1150 Exceptional Limited Pharmaceutical: Base Fee 12 £6,765
V23-K2080 Exceptional Limited Pharmaceutical: Food producing 12 £1,952

1.6 Fee for exceptional MA for an Immunological or Biological Non-immunological product

Fees for an exceptional immunological or biological non-immunological Marketing Authorisation, where there is no other product with a full UK marketing authorisation and it is based on provisional or limited data.

Immunological or Biological Non-immunological Provisional Marketing Authorisation

Fee Code Description GB VMR 2013 (as amended) Schedule 7 Para Fee from 17/05/24
V23-J3040 Exceptional Provisional Immunological/Biological Non-immunological: Base Fee 13 £10,810
V23-K304-110 Additional fee for each and/or combination of active ingredients not previously authorised in the UK 13 £5,650
V23-K304-120 Additional fee for each and/or combination of adjuvants/preservatives not previously authorised in the UK 13 £1,350
V23-K304-140 Additional fee for each antigenic component 13 £1,190
V23-K304-200 Additional fee for each additional species; first species included in base fee 13 £4,060
V23-K304-230 Additional fee for each additional route of administration; first route of administration included in base fee 13 £4,060
V23-K304-304 Simultaneous applications; fee for each additional product in the application 13 £2,895
V23-K305-110 Additional fee for each and/or combination of active ingredients not previously authorised in the UK 13 £3,702
V23-K305-120 Additional fee for each and/or combination of adjuvants/preservatives not previously authorised in the UK 13 £672
V23-K305-140 Additional fee for each antigenic component 13 £675
V23-K305-200 Additional fee for each additional species; first species included in base fee 13 £2,690
V23-K305-230 Additional fee for each additional route of administration; first route of administration included in base fee 13 £2,690
V23-K305-304 Simultaneous applications; fee for each additional product in the application 13 £1,447

Fee for Immunological and Biological Non-immunological Limited MA

Fee Code Description GB VMR 2013 (as amended) Schedule 7 Para Fee from 17/05/24
V23-J3050 Exceptional Limited Immunological/Biological Non-immunological: Base Fee 13 £5,887

1.7 Fee for the conversion from an exceptional MA to a full MA

Fee for the conversion of an exceptional marketing authorisation to a full marketing authorisation.

Fee Code Description GB VMR 2013 (as amended) Schedule 7 Para Fee from 17/05/24
V23-K115-311 Convert an Exceptional Marketing Authorisation to a full Marketing Authorisation 14 £3,000

1.8 Application fee for reassessment of an exceptional MA

Fee for the first assessment of an exceptional marketing authorisation and the fee for each subsequent reassessment.

Fee Code Description GB VMR 2013 (as amended) Schedule 7 Para Fee from 17/05/24
V23-REMA Exceptional Marketing Authorisation: First reassessment 22 £305
V23-REMAS Exceptional Marketing Authorisation: Repeated reassessment 22 £1,360

1.9 Fee for variation to a MA

Fees to apply for a variation to one or more marketing authorisations:

  • Variations to remove animal testing or to reduce the numbers of animals used in testing, there is no fee.
  • A simultaneous application for the same change(s) to multiple products, and those based on identical data, will be charged as a grouped variation.
  • Grouped variation fees will be ‘led’ by the most complex variation type contained within the application.
Fee Code Description GB VMR 2013 (as amended) Schedule 7 Para Fee from 17/05/24
V23-VSIP Standard Variation Requiring Assessment (VRA-S) 17 £2,895
V23-VRIP Reduced Variation Requiring Assessment (VRA-R) 17 £885
V23-VANFP Extension Variation Requiring Assessment (VRA-E): New route of administration; Non-food 17 £5,390
V23-VAFPA Extension Variation Requiring Assessment (VRA-E): New route of administration; Food 17 £7,135
V23-VCB Extension Variation Requiring Assessment (VRA-E): Change of bioavailability 17 £8,415
V23-VCBMS Extension Variation Requiring Assessment (VRA-E): Change of biological active substance 17 £8,415
V23-VCBMC Extension Variation Requiring Assessment (VRA-E): Change to the antigen vector or the source material 17 £8,415
V23-VCP Extension Variation Requiring Assessment (VRA-E): Change of Pharmacokinetics 17 £8,415
V23-VSA1A Extension Variation Requiring Assessment (VRA-E): Simultaneous application 17 £1,465
V23-VNA Variations not requiring assessment (VNRA) 17 £455
V23-VGS19 Grouped Variation: Standard led for the first 9 changes/products 17 £6,280
V23-VGSS5 Each subsequent group of up to 5 changes/products 17 £2,250
V23-VGR19 Grouped Variation: Reduced led for the first 9 changes/products 17 £1,770
V23-VGRS5 Each subsequent group of up to 5 changes/products 17 £2,250

1.10 Registration of a Veterinary Homeopathic Remedy

Fee for a veterinary homeopathic remedy registration prepared from homeopathic stocks using a homeopathic manufacturing procedure.

Fee Code Description GB VMR 2013 (as amended) Schedule 7 Para Fee from 17/05/24
V23-HA10 Homeopathic remedy;  formulation and stocks not assessed before, up to 5 stocks 24 £760
V23-HA20 Homeopathic remedy; formulation and stocks not assessed before, > 5 stocks 24 £985
V23-HA30 Homeopathic remedy; either formulation or stocks not assessed before, up to 5 stocks 24 £455
V23-HA40 Homeopathic remedy; either formulation or stocks not assessed before, > 5 stocks 24 £665
V23-HA50 Homeopathic remedy; formulation and stocks assessed before, up to 5 stocks 24 £160
V23-HA60 Homeopathic remedy; formulation and stocks assessed before, > 5 stocks 24 £375
V23-HE10 Homeopathic remedy; already authorised for humans in UK, up to 5 stocks 24 £160
V23-HE20 Homeopathic remedy; already authorised for humans in UK, > 5 stocks 24 £375

1.11 Annual fees for MA

The holders of UK marketing authorisations are required under the veterinary medicines regulations to pay annual fees to cover ongoing service costs.

There are two elements to the charge:

  • Graded annual fee charged at 0.67% of your declared turnover
  • Fixed annual fee; a fixed amount for each active marketing authorisation held

Guidance on how to complete and submit the turnover declaration form as the holder of a UK marketing authorisation can be found on Annual fees for marketing authorisation holders for veterinary medicines,

Fee Code Description GB VMR 2013 (as amended) Schedule 7 Para Fee from 17/05/24
V23-YFAF1 Fixed Annual Fee for each GB MA, NI MA and UK wide MA; turnover in the UK of authorised products equal to or greater than £230,000 26(2) £ (0.67T / 100) + £230n Where ‘T’ is the annual turnover and ‘n’ is the number of active marketing authorisations
V23-YFAF2 Fixed Annual Fee for each GB MA, NI MA and UK wide MA; turnover in the UK of authorised products less than £230,000 26(3) £ (0.67T / 100) + £200n Where ‘T’ is the annual turnover and ‘n’ is the number of active marketing authorisations
V23-YGAF1 Graded Annual Fee; % on turnover in the UK 26(2) 0.67%
  Failure to provide an audit certificate: Base fee 27(2) £11,300
  Failure to provide an audit certificate: Fee for each MA held 27(2) £2,245