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
| 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: | 11,600 | 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).