Fees calculator: new and variation applications for animal medicines in northern ireland

Guidance 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.

Get emails about this page DOCUMENTS FEES CALCULATOR Ref: #1471837 PDF, 906 KB, 1 page This file may not be suitable for users of assistive technology. Request an accessible format. If you

use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email [email protected]. Please tell us what format you need.

It will help us if you say what assistive technology you use. DETAILS 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). Fees are charged as set out in Schedule 7 of the Veterinary Medicines Regulations. 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’ calculator hasn’t 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) – reduced * A Type II variation is now known as a Variation Requiring Assessment (VRA) – 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a VNRA (Type IA) in a national or European grouped variation * The workshare and grouped VNRA (Type IA) options are no longer applicable for national applications For advice on use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’ calculator, please email [email protected]. SIGN UP FOR EMAILS OR PRINT THIS PAGE Get emails about this page Print this page