The Veterinary Medicines Regulations 2006

Fees for specified pharmaceutical applicationsU.K.

This section has no associated Explanatory Memorandum

6.  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.

Fees for specified pharmaceutical applications
Pharmacologically equivalent national application
MenuFull national application under Part 1 of Schedule 1 (£)Bibliographic national application (£)Reference product authorised in UK (£)Reference product not authorised in UK (£)Decentralised application where the UK is a concerned member State or recognition of a product authorised in another member State (£)
Base Fee: The following fees are in addition to the base fee—9101,8001,8002,320460
Quality assessment (if quality data are assessed):3,8103,2302,7103,4701,810
Safety assessment (if safety data are assessed):3,8103,0301,0301,3301,810
Efficacy assessment (if efficacy data are assessed):3,8103,0301,0301,3301,810
Ecotoxicology assessment (if ecotoxicology data are assessed):640520320410390
Additional fee if any of the target species is a food-producing animal (not payable if neither safety data nor ecotoxicology data are assessed):3,7403,4202,0702,6501,350
Reduced by—

  • if no safety data are assessed:

2,1002,1001,2901,650640

  • if no ecotoxicology data are assessed:

990760290370290
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom—

  • food-producing animal:

7,1706,3305,6107,2002,520

  • non-food-producing animal:

6,2605,6205,3606,8702,200
Additional fee for each additional pack type:720720590740330
Reduced by—

  • if no quality data are assessed:

350350350450120

  • if no safety data are assessed:

18018012015060

  • if no efficacy data are assessed:

6060607060

  • if no ecotoxicity data are assessed:

6060——60
Additional fee for each additional active ingredient (food-producing animal):6,2105,8703,8804,9602,000
Reduced by—

  • if no quality data are assessed:

1,4001,4001,4001,790470

  • if no safety data are assessed:

2,6302,6301,5802,020820

  • if no efficacy data are assessed:

880700530670290

  • if no ecotoxicity data are assessed:

700580——230
Additional fee for each additional active ingredient (non-food-producing animal):4,1403,9403,1103,9601,430
Reduced by—

  • if no quality data are assessed:

1,4001,4001,4001,790470

  • if no safety data are assessed:

1,4001,4008801,120470

  • if no efficacy data are assessed:

880700530670290

  • if no ecotoxicity data are assessed:

6060——60
Additional fee if there is more than one target species, for each additional species (food-producing animal):3,8203,4302,3302,9801,240
Reduced by—

  • if no quality data are assessed:

18018018022060

  • if no safety data are assessed:

1,4001,4008801,120470

  • if no efficacy data are assessed:

1,7501,4001,0501,350530

  • if no ecotoxicity data are assessed:

120120——60
Additional fee if there is more than one target species, for each additional species (non-food-producing animal):2,4002,0101,4901,900780
Reduced by—

  • if no quality data are assessed:

18018018022060

  • if no safety data are assessed:

18018012015060

  • if no efficacy data are assessed:

1,7501,4001,0501,350530

  • if no ecotoxicity data are assessed:

6060——60
Additional fee for each additional recommended route of administration (food-producing animal):2,5902,3901,5601,980910
Reduced by—

  • if no safety data are assessed:

1,4001,4008801,120470

  • if no efficacy data are assessed:

880700530670290

  • if no ecotoxicity data are assessed:

6060——60
Additional fee for each additional recommended route of administration (non- food-producing animal):1,170970720910390
Reduced by—

  • if no safety data are assessed:

18018012015060

  • if no efficacy data are assessed:

880700530670290
Simultaneous applications: fee for each additional product in the application:2,7802,7802,7803,5601,610

Commencement Information

I1Sch. 7 para. 6 in force at 1.10.2006, see reg. 1