VMD Information Hub

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 receive email alerts for 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 related information. EmailTo vedmedtrade@vmd.gov.ukregister toemail register.postmaster@vmd.gov.uk.

Information Hub explainers

Explainer subject	Summary
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, manufacturers, 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.
Mitigation explainer: Pharmacovigilance	Explainer for the pharmaceutical industry on Pharmacovigilance requirements 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)
Mitigation explainer: Labelling text	Explainer for the pharmaceutical industry on labelling text 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).
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).
Mitigation explainer: Renewals	Explainer for the pharmaceutical industry on Renewal requirements 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).

Northern Ireland update

The Windsor Framework

On 27 February 2023, the government announced the agreement in principle reached by the UK and EU regarding regarding the Windsor Framework.

AsOn per31 January 2024, the agreementgovernment published a Command Paper. This paper sets out a range of measures that would bind Northern Ireland’s political and constitutional place in Decemberthe 2022,Union, strengthen the cliffoperation edgeof onthe vetUK medsinternal hasmarket, and support ever greater opportunities for trade within it. The paper is a response to the deeply held concerns that have been removed,expressed protectingin regard to the supplyWindsor ofFramework veterinaryand medicinesthe original Northern Ireland Protocol.

As per the agreement in December 2022, and recognising the overwhelming reliance of Northern Ireland throughon toveterinary 2025medicines whilstsupplied from Great Britain, we workhave throughput in place a sustainable,grace long-termperiod solution.arrangement until the end of 2025 which supports the continuity of supply of veterinary medicines using those supply routes.

During this time, veterinary medicines authorised or approved in the UK, or which are moved via Great Britain, can continue to be placed on the market in Northern Ireland. This safeguards those supplies while providing time to establish a long-term solution which maintains the uninterrupted flow of veterinary medicines into Northern Ireland from Great Britain as is the case now.

The Government is clearcontinuing thatto awork at pace on practical, long-term solutions - as we have always been clear, the only sustainable solution mustis guaranteeone which guarantees the existing and long-established flows of trade between Great Britain and Northern Ireland on which so many people and businesses rely. To that end, the Government’s priority will be to pursue those solutions through technical discussions with the European Union.

European Commission Statement 19 December 2022

On 19 December 2022, the European Commission issued the following following statement by Vice-President Maroš Šefčovič which which provides for a three-year extension to the grace period for veterinary medicines until 31 December 2025.

These arrangements will mean that the current processes for moving veterinary medicines between Great Britain and Northern Ireland will continue to be implemented as they have been up to this point. The status quo remains until 31 December 2025.

We welcome this extension to the veterinary medicine grace period from the Commission and are looking forward to further discussions on veterinary medicines. We will continue to work for a long-term, sustainable solution to the supply of veterinary medicines.

We welcome your feedback, please send your comments to to niprotocol@vmd.gov.uk and and encourage you to continue lobbying the European Commission both on defining the issues faced by veterinary medicines and the need for a sustainable, permanent solutionsolution.

EU Regulation 2019/6 and EU Regulation 2019/4 will not be implemented in Northern Ireland – January 2022

In line with the Government announcement on maintaining standstill arrangements in September 2021, below, and while discussions on veterinary medicines continue, EU Regulation 2019/6 and EU Regulation 2019/4 willhas not bebeen implemented in Northern Ireland from 28 January 2022, except for areas previously agreed in relation to the operational aspects concerning applications for new marketing authorisations and associated life-cycle management (variations, renewals, QRD text and pharmacovigilance).

EU Regulation 2019/6 does not apply to vets and veterinary medicines in Northern Ireland, specifically Articles 110, 112, 113 and 114, from 28 January 2022, while discussions on veterinary medicines in relation to the Northern Ireland Protocol continue with the EU.

The current order of of the Cascade remains remains in effect, and vets should follow this in cases where there is no suitable veterinary medicine available in Northern Ireland. Therefore, vets may continue to import under the Cascade immunological veterinary medicines authorised in third countries (including those authorised in GB), subject to a a Special Import Certificate granted granted by the VMD.

We will keep stakeholders updated with the progress on discussions with the EU and ensure that should the situation change, sufficient notice is provided.

For information, Articles 112, 113 and 114 of EU Regulation 2019/6 set out the cascade for non-food-producing, food-producing terrestrial, and food-producing aquatic species, respectively.

Under Article 110, the import and use of an immunological veterinary medicine that is not authorised in the EU is restricted to specific conditions. The EU regulation requires that an immunological product from a third country may only be imported and used if there is no suitable medicine available under the preceding tiers of the cascade, and when one of the following conditions are met:

• In the event of an outbreak of a listed disease referred to in Article 5 of EU 2016/429 or an emerging disease referred to in Article 6 of EU 2016/429, or;
• When an immunological veterinary medicine has been authorised but is no longer available in the Union for a disease listed in Article 5 or 6 of EU 2016/429, but which is already present in the Union

None of these articles will apply in Northern Ireland while discussions on veterinary medicines in relation to the Northern Ireland Protocol continue with the EU.

Legal controls on veterinary medicines

The The Veterinary Medicines Regulations (VMR) (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. In line with our announcement on standstill arrangements, above, while negotiations with the Commission are ongoing the VMR continue to apply in Northern Ireland.

Whilst the GB and Northern Ireland VMR will remain similar, we have given details on the differences within our guidance pages.

See See Veterinary Medicines Regulations guidance for for a full list of current UK and EU regulations that apply.

The EU and UK Trade and Cooperation Agreement

Good Manufacturing Practice certificates mutual recognition

The The Trade and Cooperation Agreement (TCA) (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 our Manufacturing and distribution explainer for for further guidance.

Batch (QC) testing not included in the agreement

Although mutual recognition of batch (QC) testing was not included in the TCA, since EU Exit we have adopted a transitional approach to the batch testing and release of imported products, as described in the Information Hub explainer.

We intendlaunched to launch a consultation in 2023 which will set out our proposals for batch testing and batch release of products to be marketed in Great Britain. We will aim to make any necessary changes to batch testing and release at the same time as the other changes to the VMR.

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 the Government’s commitment for Northern Ireland businesses to have unfettered access to 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 See Veterinary medicines unfettered access from Northern Ireland for for more information.