The Veterinary Medicines Regulations 2013

[F1Application for a marketing authorisation for a pharmaceutical [F2, immunological or biological that is not immunological] veterinary medicinal product]E+W+S

This section has no associated Explanatory Memorandum

7.  The following table sets out the fees relating to a pharmaceutical [F3, immunological or biological that is not immunological] veterinary medicinal product for—

(a)[F4an application] for a marketing authorisation that is—

(i)a full application under Part 1 of Schedule 1; [F5or]

(ii)a bibliographic application [F6for a pharmaceutical veterinary medicinal product]; F7...

F8(iii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F9(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F10(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F11ApplicationFee (£) per authorisation
Base fee27,995
Fee for 1st additional strength4,590
Fee for each subsequent additional strength1,465]

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

Specified pharmaceutical applicationsN.I.

7.  The following table sets out the fees relating to a pharmaceutical veterinary medicinal product for—

(a)a national application for a marketing authorisation that is—

(i)a full application under Part 1 of Schedule 1;

(ii)a bibliographic application; or

(iii)an application based on pharmacological equivalence;

(b)an application for a marketing authorisation using the decentralised procedure where the United Kingdom is a concerned member State;

(c)an application for the mutual recognition of a product authorised in another member State.

ApplicationFull national application under Part 1 of Schedule 1 (£)Bibliographic national application (£)Pharmacologically equivalent national applicationDecentralised application where the UK is a concerned member State or recognition of a product authorised in another member State (£)
Reference product authorised in UK (£)Reference product not authorised in UK (£)
Base Fee:13,53012,1157,1959,2206,515
Additional fee if any of the target species is a food-producing animal:3,9053,5852,1552,7601,415
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom—
food-producing animal:7,4656,5955,8857,4952,630
non-food-producing animal:6,5255,8555,5907,1552,295
Additional fee for each additional pack type:740740605775330
Additional fee for each additional active ingredient (food-producing animal):6,4656,1254,0405,1652,085
Additional fee for each additional active ingredient (non-food-producing animal):4,3104,1053,2354,1351,475
Additional fee if there is more than one target species, for each additional species (food-producing animal):3,9703,5652,4253,100

1,280

Applies for a maximum of 2 additional species

Additional fee if there is more than one target species, for each additional species (non- food-producing animal):2,4952,0901,5501,980

805

Applies for a maximum of 2 additional species

Additional fee for each additional recommended route of administration (food-producing animal):2,6952,4901,6202,070940
Additional fee for each additional recommended route of administration (non- food-producing animal):1,2151,010740945405
Simultaneous applications: fee for each additional product in the application:2,8952,8952,8953,7051,685

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