# The Veterinary Medicines Regulations 2006, Paragraph 8: Application for a marketing authorisation for an immunological product

Extent: E+W+S+N.I.

(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:
11,310
5,560
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:
7,100
2,390
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:
1,300
640
More than one antigenic component—fee for each additional component:
1,290
390
More than one species—fee for each additional species:
5,170
1,550
More than one route of administration—fee for each additional route of administration:
5,170
1,550
Simultaneous application—fee for each additional product in the application:
2,780
1,610
(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 £10,020 (United Kingdom only) or £5,170 (decentralised application where the United Kingdom is a concerned member State).

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Source: https://www.legislation.gov.uk/uksi/2006/2407/schedule/7/paragraph/8 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2006/schedule-7/paragraph-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

