Guidance
Exceptional marketing authorisation - immunological
Published 16 May 2024
Applies to Northern Ireland
© Crown copyright 2024
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This publication is available at https://www.gov.uk/government/publications/fees-applied-to-veterinary-medicine-authorisation-applications-in-northern-ireland/exceptional-marketing-authorisation-immunological
1. Provisional exceptional marketing authorisation Immunological
| Fee Code | Description | Fee from 01/10/13 | VMR 2013 SCH 7 Para |
|---|---|---|---|
| J3040 | Base fee | 10,810 | 13 |
| K304-110 | Each active ingredient not previously included in a veterinary medicinal product authorised in the UK and for each new combination of active ingredients | 5,650 | 13 |
| K304-120 | 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 | 1,350 | 13 |
| K304-140 | Each additional antigenic component | 1,190 | 13 |
| K304-200 | Each additional species | 4,060 | 13 |
| K304-230 | Each additional route of administration | 4,060 | 13 |
| K304-304 | Simultaneous application: fee for each additional product in the application | 2,895 | 13 |
| J3110 | Conversion of an exceptional marketing authorisation to full MA | 3,000 | 14 |
2. Limited exceptional Immunological authorisation
| Fee code | Description | Fee from 01/10/13 | VMR 2013 SCH 7 Para |
|---|---|---|---|
| J3050 | Base fee | 5,887 | 13 |
| K305-110 | Each active ingredient not previously included in a veterinary medicinal product authorised in the UK and for each new combination of active ingredients | 3,702 | 13 |
| K305-120 | 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 | 672 | 13 |
| K305-140 | Each additional antigenic component | 675 | 13 |
| K305-200 | Each additional species | 2,690 | 13 |
| K305-230 | Each additional route of administration | 2,690 | 13 |
| K305-304 | Simultaneous application: fee for each additional product in the application | 1,447 | 13 |
| J3110 | Conversion of an exceptional marketing authorisation to full MA | 3,000 | 14 |
3. Parallel Import
| Fee code | Description | Fee from 01/10/13 | VMR 2013 SCH 7 Para |
|---|---|---|---|
| MAP1 | Application where the imported product has not been authorised in accordance with the mutual recognition procedure or the decentralised procedure but where the imported product originates from the same manufacturing site as the product authorised in the UK | 2,130 | 15 |
| MAP2 | Where the imported product has been authorised in accordance with the mutual recognition procedure or decentralised procedure, and the NI is included in these procedures; import from 1 EU Member State | 1,755 | 15 |
| MAP4 | Application to add an additional EU Member State after the marketing authorisation has been granted; fee for each Member State | 455 | 15 |
| MAP5 | Any other application; fee for each EU Member State from which the product is imported | 4,710 | 15 |