SCHEDULE 7Fees
PART 2Fees relating to marketing authorisations
Application for a marketing authorisation for an immunological or biosimilar productE2F19
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for a marketing authorisation for an immunological or biosimilar productE19
1
The fee for a national application for a marketing authorisation relating to an immunological or biosimilar 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.
2
In this paragraph a biosimilar application means an application made in accordance with Article 13(4) of Directive 2001/82/EC and a biosimilar product means a product which is the subject of such an application.
Application | 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 (£) | |
|---|---|---|---|
1. Immunological or biosimilar product other than in paragraph 2 below: Base fee: | 11,775 | 5,785 | |
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: | 7,405 | 2,490 | |
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: | 1,345 | 675 | |
More than one antigenic component – fee for each additional component: | 1,350 | 405 | |
More than one species – fee for each additional species: | 5,380 | 1,615 Applies for a maximum of 2 additional species | |
More than one route of administration – fee for each additional route of administration: | 5,380 | 1,615 | |
Simultaneous application - fee for each additional product in the application: | 2,895 | 1,685 | |
2. Immunological or product that is identical to a product already authorised in the United Kingdom but with a lesser number of antigens and that only contains antigens contained in that product: | 10,430 | 5,380 | |