Application for a marketing authorisation for an immunological or biosimilar productE+W+S
9.—(1) The fee for [F1an application] for a marketing authorisation relating to an immunological or biosimilar product,F2... 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.
Fees for specified immunological and biosimilar applications
| Application | F3... application for a marketing authorisation(£) | F4... | |
|---|---|---|---|
| 1. Immunological or biosimilar product other than in paragraph 2 below: Base fee: | 11,775 | F4... | |
| The following fees are in addition to the base fee— | F4... | ||
| 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 | F4... | |
| 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 | F4... | |
| More than one antigenic component – fee for each additional component: | 1,350 | F4... | |
| More than one species – fee for each additional species: | 5,380 | F4... | |
| More than one route of administration – fee for each additional route of administration: | 5,380 | F4... | |
| Simultaneous application - fee for each additional product in the application: | 2,895 | F4... | |
| 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 | F4... | |
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F1Words in Sch. 7 para. 9(1) substituted (E.W.S.) (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(d)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Sch. 7 para. 9(1) omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(d)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
F3Word in Sch. 7 para. 9 Table omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(d)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F4Words in Sch. 7 para. 9 Table omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(d)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Application for a marketing authorisation for an immunological or biosimilar productN.I.
9.—(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.
Fees for specified immunological and biosimilar applications
| 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 | |
Extent Information
E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only