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 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 vedmedtrade@vmd.gov.uk to register.

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, 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

Introduction of the Northern Ireland Protocol Bill

On 17 May 2022 the Foreign Secretary set out to the House of Commons that primary legislation would be brought forward to restore the balance inherent in the objectives of the Protocol - avoiding a hard border, protecting the integrity of the UK and safeguarding the EU Single Market.

The Northern Ireland Protocol Bill was introduced to Parliament on 13 June and a statement that summarises the legal position was published, that such legislation is lawful under international law. Also published was a problems and solutions document and the press release.

Veterinary medicines are covered under the ‘manufactured goods, medicines and agri-foods’ references within the regulation of goods section (clauses 7-11). Despite strong industry concern about the EU’s current position on imposing import requirements at the end of 2022, the EU has not proposed any long-term solutions for veterinary medicines. If we can’t reach a negotiated agreement with the EU on all veterinary medicines, we will use the Bill to ensure continuity of supply of veterinary medicines throughout the UK.

The Bill

The Bill will provide us with the powers to disapply elements of EU law under the Protocol, for example those relating to EU rules on veterinary medicines. The Bill also provides the power for Ministers to make new law in connection with the Protocol, which could be used to create a UK-wide veterinary regime. This would remove regulatory barriers and supply challenges that will arise should the grace period end at the end of 2022.

We would like to reach a negotiated arrangement with the EU on veterinary medicines and if we are able to do this, the Bill will provide us with the powers to implement this, if necessary. Alternatively the EU could adjust its own legislation, as they have done for human medicines. In either event, the Bill will enable us to provide a long-term fix to supply concerns.

Nothing is changing for now

In the short-term, there will be no changes as the Bill may take up to 12-months to go through the parliamentary approval process and gain Royal Assent. As always, we will keep you regularly updated with developments.

Future engagement and contingency measures

The Bill will allow us to go back to a single UK-wide regime which will simplify and address the supply and regulatory issues caused by the Protocol for NI. We will of course consult industry on this in due course.

If the Bill is not passed by the end of 2022 (and the end of the grace period), the UK will consider further measures to protect the supply of veterinary medicines in NI.

We welcome feedback on the proposals within the Bill to NIProtocol@vmd.gov.uk.

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

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 will not be 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 Northern Ireland Protocol continue with the EU.

Government statement 17 December 2021

On 17 December 2021 the EU Commission issued a statement noting the progress for human medicines. As stated in the UK Governments’ statement of the 6 September 2021, below, the grace period for veterinary medicines has been extended to beyond the end of 2021 to allow further time for UK-EU discussions. These arrangements will mean that the current processes for moving veterinary medicines between Great Britain and Northern Ireland will continue to be administered as they have been up to this point.

While we welcome this communication from the Commission, we are disappointed in the lack of progress made on veterinary medicines in the past 12 months but welcome further discussions in the New Year. We remain hopeful that a resolution will be found within the next year. As previously stated, 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 UK Government have also issued an announcement, which recognises the European Commission statement, but notes that further work is needed including on veterinary medicines. The position regarding medicines in the Command Paper, which was published in July, is maintained. This is the simple solution of removing medicines, including veterinary medicines, from the scope of the protocol.

Remarks can be found from the press conference from both Health Commissioner Stella Kyriakides and Commission VP Maros Sefcovic with a link to the [proposed EU human medicine legislative proposals]https://ec.europa.eu/info/strategy/relations-non-eu-countries/relations-united-kingdom/eu-uk-withdrawal-agreement/protocol-ireland-and-northern-ireland_en#october-2021-package (scroll down to the “documents” section of the webpage to find them).

Our Information Hub already contains guidance pages to reflect the arrangement to extend the grace period for veterinary medicines.

We welcome your feedback, please send your comments to niprotocol@vmd.gov.uk and would encourage you to continue to lobby the European Commission to find a solution for veterinary medicines.

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 niprotocol@vmd.gov.uk.

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. 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 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 2022, 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. However, 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 2022 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.