F120. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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
F1Sch. 7 para. 20 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)(k); 2020 c. 1, Sch. 5 para. 1(1)
20.—(1) Where an application is made for the Secretary of State to provide information to other member States to enable them to recognise a marketing authorisation already granted by the United Kingdom the following fees are payable.
(2) Those fees also apply where a marketing authorisation has been granted in more than one member State, the holder applies for an extension for that marketing authorisation and the United Kingdom acts as reference member State.
(3) Where a valid application to provide information to another member State is received within six months of the original grant of the marketing authorisation, or where the Secretary of State has already provided the information to a member State, and a further valid application is made to provide the information to an additional member State within six months of the date the last information was provided, the fees are—
| Type of application | Fee for a pharmacologically equivalent product(a) | Fee (other products) (£) | ||
|---|---|---|---|---|
(a) This fee is payable if the application for the marketing authorisation was on the basis that the product was pharmacologically equivalent to another veterinary medicinal product. | ||||
| Pharmaceutical product for a food-producing animal – one member State: | 3,940 | 2,440 | ||
| Pharmaceutical product for a non-food-producing animal ‑ one member State: | 2,645 | 1,895 | ||
| Immunological product – one member State: | 2,130 | 2,130 | ||
| Each additional member State: | 535 | 535 | ||
(4) Where the information to be provided relates to a product granted a marketing authorisation using identical data submitted simultaneously or on the basis of information provided under Article 13(c) of Directive 2001/82/EC the fees are—
| Application | Fee (£) | |
|---|---|---|
| Provision of information to— | ||
| one member State: | 4,165 | |
| each additional member State: | 530 | |
(5) In any other case the fees are—
| Type of application | Fee for a pharmacologically equivalent product (£)(a) | Fee (other products) (£) | |
|---|---|---|---|
(a) This fee is payable if the application for the marketing authorisation was on the basis that the product was pharmacologically equivalent to another veterinary medicinal product. | |||
| Pharmaceutical product for a food-producing animal – one member State: | 12,015 | 10,515 | |
| Pharmaceutical product for a non-food-producing animal – one member State: | 8,115 | 7,365 | |
| Immunological product – one member State: | 8,940 | 8,940 | |
| Each additional member State: | 535 | 535 | |
(6) In the case of simultaneous applications, the above fees are payable for each additional product in the application for one member State, with a fee of £115 for each additional product for each additional member State.
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