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The Veterinary Medicines Regulations 2009

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This is the original version (as it was originally made).

Application for a marketing authorisation for an immunological product

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9.  The fee for a national application for a marketing authorisation relating to an immunological product, a decentralised application where the United Kingdom is the concerned member State or the mutual recognition of a product authorised in another member State is in accordance with the following table.

Fees for specified immunological applications
MenuNational application for a marketing authorisation(£)Decentralised application where the UK is a concerned member State or recognition of a product authorised in another member State (£)

1. Immunological product other than in paragraph 2:

Base fee:

11,7755,785
The following fees are in addition to the base fee.
  • Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom, and for each new combination of active ingredients:

7,4052,490
  • Additional fee for each adjuvant or preservative not previously included in a veterinary medicinal product authorised in the United Kingdom and for each new combination of adjuvants or preservatives:

1,345675
  • More than one antigenic component – fee for each additional component:

1,350405
  • More than one species – fee for each additional species

5,3801,615
  • More than one route of administration – fee for each additional route of administration

5,3801,615
  • Simultaneous application - fee for each additional product in the application

2,8951,685

2. Immunological product that is identical to a product already authorised in the United Kingdom but with a lesser number of antigens and that only contains antigens contained in that product

10,4305,380

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