Fees calculator: new and variation applications for animal medicines in Northern Ireland
Fees are charged for new marketing authorisation (MA) applications and variations to MAs.
Documents
Details
Due to the complexity involved for fees specific to Northern Ireland, you can use the聽fees calculator聽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).
Fees are charged as set out in . A breakdown of fees relating to veterinary medicines (to include parallel submission administrative reductions) is available on Fees applied to animal medicine authorisation applications.
The fees calculator is a tool to help you work out how much your application for a new Marketing Authorisation (MA) or a variation to an existing MA is likely to cost.
This file may be opened in Firefox, Internet Explorer or Google Chrome. You may find it difficult to open this file if Microsoft Edge is set as your default browser.
It is an interactive form, as you answer one question the next relevant question will appear.
From 28th Jan 2022
The terms used for variations are changing on 28 January 2022. The fees鈥� calculator hasn鈥檛 been updated yet to reflect these new terms, so we have included some guidance below.
We also strongly encourage you to read the revised variation guidance before submitting a variation application.
- A Type IA variation is now known as a Variation Not Requiring Assessment (VNRA)
- A Type IB variation is now known as a Variation Requiring Assessment (VRA) 鈥� reduced
- A Type II variation is now known as a Variation Requiring Assessment (VRA) 鈥� standard / extended
- You cannot include a VNRA (Type IA) in a national or European grouped variation
- The workshare and grouped VNRA (Type IA) options are no longer applicable for national applications
For advice on use of the fees鈥� calculator, please email [email protected].