Fees relating to Marketing Authorisations (MA)
Published 16 May 2024
Applies to England, Scotland and Wales
© Crown copyright 2024
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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 |
1.4 MA based on informed consent
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 |
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 |