# The Veterinary Medicines Regulations 2007, Paragraph 9: Application for a marketing authorisation for an immunological product


(1) The fee for a national application for a marketing authorisation relating to an immunological product, a decentralised application where the United Kingdom is the concerned member State or the mutual recognition of a product authorised in another member State is in accordance with the following table.
Fees for specified immunological applications
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National application for a marketing authorisation(£)
Decentralised application where the UK is a concerned member State or recognition of a product authorised in another member State (£)
Base fee:
11,600
5,700
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:
7,290
2,450
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:
1,330
660
More than one antigenic component—fee for each additional component:
1,330
400
More than one species—fee for each additional species:
5,300
1,590
More than one route of administration—fee for each additional route of administration:
5,300
1,590
Simultaneous application—feefor each additional product in the application:
2,850
1,660
(2) The fee for an application for a marketing authorisation for an immunological product that is identical to a product already authorised in the United Kingdom but with a lesser number of antigens and which only contains antigens contained in the product already authorised is £10,270 (United Kingdom only) or £5,300 (decentralised application where the United Kingdom is the concerned member State).

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Source: https://www.legislation.gov.uk/uksi/2007/2539/schedule/7/paragraph/9 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-7/paragraph-9
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.