The Veterinary Medicines Regulations 2009

Fees for an application for an exceptional marketing authorisation (immunological)

This section has no associated Explanatory Memorandum

13.  The fee for an application for an exceptional marketing authorisation for an immunological product is in accordance with the following table.

Fees for an exceptional marketing authorisation for an immunological product
MenuFee (£)
Base fee:10,810
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
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
More than one antigenic component – fee for each additional component:1,190
More than one species – fee for each additional species:4,060
More than one route of administration – fee for each additional route of administration:4,060
Simultaneous application - fee for each additional product in the application2,895