VMD Information Hub

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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 related information. To register email postmaster@vmd.gov.uk.

New legislation now in force

The Veterinary Medicines (Amendment etc.) Regulations 2024, which amend the Veterinary Medicines Regulations 2013 in respect of Great Britain, are now in force.

You can find the legislation here: The Veterinary Medicines (Amendment etc.) Regulations 2024 (legislation.gov.uk).

The Regulations contain transitional provisions for certain requirements, set out in Part 10, for which we have created an explainer which you can find in the table below.

We have published updated guidance documents to reflect the amendments introduced by the new Regulations, which can be found on our collection page with Veterinary medicines guidance. The draft guidance previously published on this page has now been removed to avoid confusion.

If you have any questions about the new Regulations or feedback on the guidance, please contact us at vmr@vmd.gov.uk.

Authorisation requirements

As a result of the mitigations put in place in February 2021 (set out below), many of the changes introduced by the amended Regulations to veterinary medicine approval processes are already implemented.

From 17 May 2024, the following additional changes relevant to Marketing Authorisation Holders take effect:

Renewals

Marketing Authorisations are no longer subject to renewal and are valid indefinitely. For those Marketing Authorisations that were due to be renewed after 17 May further renewal applications will not be required. Exceptional MAs continue to be required to be reassessed annually.

Marketing Authorisations for Parallel Import (MAPI)

MAPIs are no longer provided for in the amended Regulations. Existing authorisations remain in effect for the UK, however applications for new MAPIs will not be accepted.

Authorisation application fees

For applications validated after 17 May the amended fees set out in GB and NI will apply. For all applications you will be invoiced based on the legislation in force on the date of invoicing.

Labelling for authorised veterinary medicines

From 29 April new labelling requirements are in effect. More information can be found in the Product Information Template guidance.

Reporting supply issues

From 17 May, MA holders are obliged to report any identified supply problems as soon as reasonably practical. To do so, email a completed supply issue report form to supply@vmd.gov.uk.

Information Hub explainers

Explainer subject	Summary
Fee changes in the VMR	Explainer for the pharmaceutical industry on the implementation of the Veterinary Medicines Regulations relating to fees for applications and authorisations for veterinary medicines
Pharmacovigilance	Explainer for the pharmaceutical industry on the implementation of the Veterinary Medicines (Amendment etc.) Regulations 2024 relating to pharmacovigilance.
Mitigation explainer: Labelling text - Product Information Templates for Veterinary Medicines (SPC and QRD Text)	Explainer on product information templates to be used by applicants and Marketing Authorisation Holders (MAHs) of veterinary medicines.
Explainer: transitional provisions in new Regulations	Explainer for businesses and persons regulated by the Veterinary Medicines Regulations 2013, as amended, on the transitional provisions included in the amending legislation: the Veterinary Medicines (Amendment etc.) Regulations 2024.

Northern Ireland update

The Windsor Framework

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

On 31 January 2024, the government published a Command Paper. This paper sets out a range of measures that would bind Northern Ireland’s political and constitutional place in the Union, strengthen the operation of the UK internal market, and support ever greater opportunities for trade within it. The paper is a response to the deeply held concerns that have been expressed in regard to the Windsor Framework.

As per the agreement in December 2022, and recognising the overwhelming reliance of Northern Ireland on veterinary medicines supplied from Great Britain, we have put in place a grace period 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 continuing to work at pace on practical, long-term solutions - as we have always been clear, the only sustainable solution is one 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 statement by Vice-President Maroš Šefčovič 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 windsorframework@vmd.gov.uk 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 solution.

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 has not been 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 the Cascade 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 Special Import Certificate 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 Windsor Framework continue with the EU.

Legal controls on veterinary medicines

The Veterinary Medicines Regulations (VMR) 2013 (Statutory Instrument 2013/2033), as amended, remain in force for the regulation of veterinary medicines in the UK.

The Windsor Framework provides for Northern Ireland to remain subject to EU legislation. To ensure effective implementation of the Windsor Framework, the VMR were amended to provide, in effect, two sets of Regulations having effect in GB and Northern Ireland, respectively. In line with our announcement on standstill arrangements, above, while discussions with the Commission are ongoing the VMR continue to apply in Northern Ireland.

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

See Veterinary Medicines legislation guidance 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 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

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 launched a consultation in 2023 which 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.

Windsor Framework

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.

VMD Information Hub