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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 thefees calculatorto 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 Dealers authorisation

1. Wholesale Dealers authorisation

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

1. Single variation applications

2. National

3. Mutually recognised NI MAs

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