Guidance
New marketing authorisations - immunological or biosimilar
Updated 4 July 2024
Applies to Northern Ireland
© Crown copyright 2024
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/fees-applied-to-veterinary-medicine-authorisation-applications-in-northern-ireland/new-marketing-authorisations-immunological-or-biosimilar
1. Full national immunological or biosimilar applications
| Fee code | Description | Fee from 01/10/13 | VMR 2013 SCH 7 Para |
|---|---|---|---|
| J3010 | Base fee | 11,775 | 9 |
| K301-110 | Each active ingredient not previously included in a veterinary medicinal product authorised in the UK and for each new combination of active ingredients | 7,405 | 9 |
| K301-120 | Each adjuvant or preservative not previously included in a veterinary medicinal product authorised in the UK and for each new combination of adjuvants or preservatives | 1,345 | 9 |
| K301-140 | Each additional antigenic component | 1,350 | 9 |
| K301-200 | Each additional species | 5,380 | 9 |
| K301-230 | Each additional route of administration | 5,380 | 9 |
| K301-304 | Simultaneous application: fee for each additional product in the application | 2,895 | 9 |
| K301-307 | Application for a marketing authorisation for an immunological product that is identical to a product already authorised in the UK but with a lesser number of antigens and that only contains antigens contained in that product | 10,430 | 9 |
2. Decentralised or Mutual Recognition (NI CMS)
| Fee code | Description | Fee from 01/10/13 | VMR 2013 SCH 7 Para |
|---|---|---|---|
| J3020 | Base fee | 5,785 | 9 |
| K302-110 | Each active ingredient not previously included in a veterinary medicinal product authorised in the UK and for each new combination of active ingredients | 2,490 | 9 |
| K302-120 | Each adjuvant or preservative not previously included in a veterinary medicinal product authorised in the UK and for each new combination of adjuvants or preservatives | 675 | 9 |
| K302-140 | Each additional antigenic component | 405 | 9 |
| K302-200 | Each additional species (max of 2) | 1,615 | 9 |
| K302-230 | Each additional route of administration | 1,615 | 9 |
| K302-305 | Simultaneous application: fee for each additional product in the application | 1,685 | 9 |
| K302-308 | Application for a marketing authorisation for an immunological product that is identical to a product already authorised in the UK but with a lesser number of antigens and that only contains antigens contained in that product | 5,380 | 9 |