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The Veterinary Medicines Regulations 2013

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[F1Application for a marketing authorisation for a pharmaceutical veterinary medicinal product]E+W+S

This adran has no associated Memorandwm Esboniadol

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

(a)[F2an 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;

F3(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)F4...

ApplicationFull F5...application under Part 1 of Schedule 1 (£)Bibliographic F6...application (£)F7...
[F8Pharmacologically equivalent application]F7...
Base Fee:13,53012,1157,195F7F7
Additional fee if any of the target species is a food-producing animal:3,9053,5852,155F7F7
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom—
food-producing animal:7,4656,5955,885F7F7
non-food-producing animal:6,5255,8555,590F7F7
Additional fee for each additional pack type:740740605F7F7
Additional fee for each additional active ingredient (food-producing animal):6,4656,1254,040F7F7
Additional fee for each additional active ingredient (non-food-producing animal):4,3104,1053,235F7F7
Additional fee if there is more than one target species, for each additional species (food-producing animal):3,9703,5652,425F7F7
Additional fee if there is more than one target species, for each additional species (non- food-producing animal):2,4952,0901,550F7F7
Additional fee for each additional recommended route of administration (food-producing animal):2,6952,4901,620F7F7
Additional fee for each additional recommended route of administration (non- food-producing animal):1,2151,010740F7F7
Simultaneous applications: fee for each additional product in the application:2,8952,8952,895F7F7

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

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