Guidance

Fees applied to veterinary medicine authorisation applications in Northern Ireland

Definitive fees charged for applications under Schedule 7 of the Veterinary Medicines Regulations 2013.

From:
Veterinary Medicines Directorate
Published
16 May 2024

Applies to Northern Ireland

Documents

Parallel submission administrative reductions

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New marketing authorisation - pharmaceutical

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New marketing authorisations - immunological or biosimilar

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Exceptional marketing authorisation - pharmaceutical

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Exceptional marketing authorisation - immunological

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Manufacturers authorisation and Inspections

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Wholesale Dealer’s authorisation

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Variations to Marketing Authorisations (MAs) or Veterinary Homeopathic Remedies (VHRs)

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Grouped variation applications

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Animal Test Certificates

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Feedingstuffs

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General

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Details

Definitive fees charged for applications in Northern Ireland are set out in this document.

Due to the complexity involved for fees specific to Northern Ireland, you can use the fees calculator to help you work out what the fee will be for a new marketing authorisation or variation. However, not all selections available within the calculator are valid. For example, UK can no longer be a lead assessment authority (RMS).

The fees listed below are Pounds Sterling (£).

MA Parallel submission administrative reductions

  1. New GB MA and national only NI

  2. New GB MA and decentralised procedure MA with NI as CMS

  3. Variations: GB MA and national NI MA

  4. Variations: GB MA and mutually recognised NI MA

  5. Provision of advice

New marketing authorisation - pharmaceutical

  1. Full national pharmaceutical applications

  2. Bibliographic national pharmaceutical applications

  3. Pharmacologically-equivalent product – national MAs - UK authorised reference product

  4. Pharmacologically‐equivalent product – mutually recognised MAs ‐ EU authorised reference product (NI only)

  5. Decentralised or Mutual Recognition (NI CMS)

New marketing authorisations - immunological or biosimilar

  1. Full national immunological or biosimilar applications

  2. Decentralised or Mutual Recognition (NI CMS)

Exceptional marketing authorisation - pharmaceutical

  1. Provisional exceptional marketing authorisation pharmaceutical

  2. Limited exceptional pharmaceutical marketing authorisation

Exceptional marketing authorisation - immunological

  1. Provisional exceptional marketing authorisation Immunological

  2. Limited exceptional Immunological authorisation

  3. Parallel Import

Manufacturers authorisation

  1. Manufacturers authorisation

  2. Manufacturing site inspections

Wholesale Dealer’s authorisation

  1. Wholesale Dealer’s authorisation

Variations to Marketing Authorisations (MAs) or Veterinary Homeopathic Remedies (VHRs)

  1. Single variation applications

  2. National

  3. Mutually recognised NI MAs

Grouped variation applications

  1. National

  2. Mutually recognised NI MAs

  3. Workshare variation applications

  4. Veterinary homeopathic remedy

Animal Test Certificates

  1. Animal Test Certificates

Feedingstuffs

  1. Feedingstuffs

General

1.Renewal of an Exceptional marketing authorisation

  1. Annual fees for marketing authorisations

  2. Specific batch control

  3. Test sites, Blood Banks, Stem Cells

  4. Testing of samples

  5. Inspection improvement notices

  6. Approval of premises for supply by Suitably Qualified Persons

  7. Immunological site inspections

  8. Pharmaceutical site inspections

  9. Veterinary surgeon’s practice inspection

  10. Special Import and Export certificates

  11. Appeal to the Veterinary Products Committee

  12. Referral to an appointed person

  13. Non-payment of fees

Published 16 May 2024

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