The Veterinary Medicines Regulations 2013

Provision of information relating to the recognition of a United Kingdom marketing authorisation or an extension E+W+S

F1 20.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E1 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F1 Sch. 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)

Provision of information relating to the recognition of a United Kingdom marketing authorisation or an extension N.I.

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

E2 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only