Paragraph 8 Application for a marketing authorisation for an immunological productI1
United Kingdom
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: | 11,310 | 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 |
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).
Annotations
Commencement
- I1
Sch. 7 para. 8 in force at 1.10.2006, see reg. 1