Paragraph 13 Fees for an application for an exceptional marketing authorisation (immunological or biological non-immunological)F2E1
England, Wales and Scotland
The fee for an application for an exceptional marketing authorisation for an immunological product F1or a biological veterinary medicinal product that is not immunological is in accordance with the following table.
Fees for an exceptional marketing authorisation for an immunological product or a biological veterinary medicinal product that is not immunological
| Application | Provisional (£) | Limited (£) |
|---|---|---|
| Base fee: | 10,810 | 5,887 |
| The following fees are in addition to the base fee— | ||
| Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom, and for each new combination of active ingredients: | 5,650 | 3,702 |
| Additional fee for each adjuvant or preservative not previously included in a veterinary medicinal product authorised in the United Kingdom and for each new combination of adjuvants or preservatives: | 1,350 | 672 |
| More than one antigenic component – fee for each additional component: | 1,190 | 675 |
| More than one species – fee for each additional species: | 4,060 | 2,690 |
| More than one route of administration – fee for each additional route of administration: | 4,060 | 2,690 |
| Simultaneous application - fee for each additional product in the application: | 2,895 | 1,447 |
Annotations
Textual amendments
- F1
Words in Sch. 7 para. 13 inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 168(a)
- F2
Words in Sch. 7 para. 13 heading substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 168(b)
Extent
- E1
This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only