This is the Hub for all the Veterinary Medicines Directorate's communications on current and future regulatory changes.
VMD Information Hub
This is the Hub for all the Veterinary Medicines Directorate’s communications on current and future regulatory changes.
You can sign up to receive email alerts for all our news and announcements through GOV.UK to make sure you get the latest information as soon as it becomes available. In addition to this we have a mailing list for those in your organisation only interested in receiving updates made to the Hub and other regulatory transition related information. Email email@example.com to register.
Northern Ireland update
Government statement 6 September 2021
To give certainty and stability to businesses while UK-EU discussions proceed, the Government has announced that it will maintain “standstill” arrangements. These arrangements will mean that the current processes for moving goods between Great Britain and Northern Ireland will continue to be administered as they have been up to this point.
This includes veterinary medicines and the deadline of the 31 December 2021 for third country importation requirements given on our Information Hub no longer applies. Instead, once discussions with the EU are concluded, the Government will ensure that reasonable notice is provided in the event that these arrangements are to change, to enable businesses to make appropriate preparations. The length of the notice period will depend on the outcome of discussions.
The European Commission have issued a statement in response, which recognises the UK announcement and states that they do not plan on opening any new infringements for now, wishing to engage constructively on the Protocol.
This is lawful and consistent with the Government’s good faith efforts to find a durable settlement on the Protocol.
We believe there is a shared understanding with the EU of the importance of providing stability to operators while those discussions proceed.
We will update guidance pages to reflect this arrangement in due course.
We welcome your feedback, please send your comments to firstname.lastname@example.org.
Information Hub explainers
|Application and authorisation||Explainer for the pharmaceutical industry on the implementation of the Veterinary Medicines Regulations relating to applications and authorisations for veterinary medicines|
|Manufacturing and distribution||Explainer for Marketing Authorisation holders, wholesale dealers, retailers (including veterinary surgeons) and feed business operators on the manufacture and movement of veterinary medicines.|
|Pharmacovigilance||Explainer for the pharmaceutical industry on the implementation of the Veterinary Medicines Regulations relating to Pharmacovigilance.|
Legal controls on veterinary medicines
The Veterinary Medicines Regulations (VMR) 2013 (Statutory Instrument (SI) 2013/2033), as amended, remains in force for the regulation of veterinary medicines in the UK.
The Northern Ireland Protocol (the Protocol) provides for Northern Ireland to remain subject to EU legislation. To ensure effective implementation of the Protocol, the VMR is amended to provide, in effect, 2 sets of Regulations having effect in GB and Northern Ireland, respectively.
Whilst the GB and Northern Ireland VMR will remain similar, we have given details on the differences within our guidance pages.
See Veterinary Medicines Regulations guidance for a full list of current UK and EU regulations that apply.
Future Veterinary Medicines Regulations
We have in place continued recognition of certain regulatory functions carried out in the EU for batches placed on to the market by 31 December 2022. These are described within our Information Hub explainers.
Many of the requirements from 2023 will form part of the new Veterinary Medicines Regulations. The proposed changes to the Regulations will be subject to formal, public consultation in 2021, when you will have an opportunity to comment.
The EU and UK Trade and Cooperation Agreement
Good Manufacturing Practice certificates mutual recognition
The Trade and Cooperation Agreement (TCA) between the EU and the UK sets out the conditions for the mutual recognition of Good Manufacturing Practice (GMP) certificates issued by their National Competent Authorities (NCAs) for medicinal products, including veterinary medicines. See our Manufacturing and distribution explainer for further guidance.
Batch (QC) testing not included in the agreement
Unfortunately, the European Commission would not engage with us on the inclusion of mutual recognition of batch (QC) testing in the agreement. Therefore, you should refer to the guidance given in our Manufacturing and distribution and Product Movement explainers .
To help ensure continuity of supply of veterinary medicines on the GB market, we will unilaterally recognise batch (QC) testing conducted in the EU/EEA until 31 December 2022. The arrangements for beyond 2022 will form part of the new Veterinary Medicines Regulations. The proposed changes to the Regulations will be subject to formal, public consultation during 2021 when you will have an opportunity to comment.
Northern Ireland Protocol
The Northern Ireland Protocol (‘the Protocol’) overall principles that guided the UK Government’s approach were set out in the 20 May Command Paper, The UK’s approach to the Northern Ireland Protocol.
Guidance providing support for businesses engaging in new processes under the Protocol is also available and you will be eligible for support under the Trader Support Service (TSS).
The VMD will continue to act as the UK Competent Authority and will conduct regulatory functions on behalf of Northern Ireland.
As part of the Government’s commitment for Northern Ireland businesses to have unfettered access to the rest of the UK market, marketing authorisation holders (MAHs) and authorised suppliers of qualifying veterinary medicines based in Northern Ireland will be able to move their products from Northern Ireland to the rest of the UK and place them on the market in Great Britain. See Veterinary medicines unfettered access from Northern Ireland for more information.