Mitigation explainer: Variations
Explainer for the pharmaceutical industry on variation related mitigations to bridge the gap between the implementation of the EU Regulation on veterinary medicines and the revised Veterinary Medicines Regulations as they have an effect in Great Britain (GB VMR).
Documents
Details
Mitigations for Veterinary Medicines Regulations
EU Regulation 2019/6 will apply in the EU from 28 January 2022. We played an active role in developing and negotiating the Regulation when we were part of the EU and therefore agree with much of its content.
The GB Veterinary Medicines Regulation (VMR) is under review and will undergo a formal public consultation. Until such time that the revised GB VMR come into force, there will be what we call an “airgap” between both sets of legislation covering EU (NI) and GB.
We recognise that industry is set up to cover the region of Europe, which includes the UK, and its regulatory requirements. As an interim measure we have considered areas where we may bridge this gap between the EU Legislation and the current VMR, as they have an effect in GB, whilst still respecting both sets of legislation to reduce burdens to the industry and help facilitate the continued availability of veterinary medicines in NI and GB.
IMPORTANT: This is an interim measure and does not pre-empt or prejudice the outcome of the formal consultation on the GB VMR as we will take account of views from a wide range of stakeholders.
Mitigation for new variation applications
Variations Not Requiring Assessment (VNRA) and Variations Requiring Assessment (VRA)
For new GB and/or Northern Ireland Marketing Authorisation (MA) variation national applications validated on or after the 28 January 2022, we will follow the new EU 2019/6 variation regime:
- VNRA: similar to current Type 1A
- VRA: broken down into sub-categories - reduced timetable similar to Type IB, and standard or extended timetable similar to Type II.
You cannot include a VNRA (Type IA) in a national or European grouped variation and the workshare procedure is no longer available to GB and/or NI national applications.
For Northern Ireland MA authorised via a European procedure, VNRA should be submitted via the Union Product Database. Further guidance is available from the EMA.
Variation-Extension applications
For changes previously known as Variation-Extensions, you can:
1) Change an existing MA via a VRA application (categories I.I.1.a) – f), I.II.1.a) – e), and I.III.1.a). The timetable will be equivalent to the VRA ‘Extended’ timetable, which is 60 days but can be increased to 90 days for complex assessments. If the changes will result in new packaging, for example addition of a new pharmaceutical form, then you cannot apply via a VRA application and will need to apply for and create a new stand-alone MA.
2) Create a new stand-alone MA via a new-extension application. This procedure will result in a new MA and the original ‘parent’ product will remain unchanged. The national complex MA assessment timetable will apply (210 days).
Application Forms
UK template for GB-national only
VRA and VNRA electronic application forms will be made available on VMDS in due course. In the interim, simple application forms will be made available on Variations to a veterinary MA guidance from 28 January 2022 and you will need to submit these via VMDS. Copies of these forms are available on this page to enable you to familiarise yourself with the information required.
Applications validated before 28 January 2022
Applications validated before 28 January 2022 will conclude using their original Type IA, IB, II or Variation-Extension procedures and timetables.
Fees
The fees applied to animal medicine authorisation applications remain unchanged. The new variation regime introduces new terminology for variation types and procedures. These are:
| Schedule 7 | Equivalent New Variation Regime |
|---|---|
| Type IA | VNRA |
| Type IB | VRA – Reduced |
| Type II | VRA – Standard/Extended |
Contact us
For all enquiries email: postmaster@vmd.gov.uk
Last updated 5 July 2022 + show all updates
-
Update to new variation applications and VRA and VNRA forms.
-
First published.