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8.—(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.
Menu | 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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