VMD Information Hub
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 related information. To register email postmaster@vmd.gov.uk.
Draft guidance for upcoming changes to legislation
The guidance listed below is in draft and under review, and may be further developed. We have published the draft guidance to aid you in your consideration of the upcoming changes to the Veterinary Medicines Regulations 2013 (VMR) in respect of Great Britain.
The changes that will be made by the statutory instrument ‘The Veterinary Medicines (Amendment etc.) Regulations 2024’ and the draft guidance set out below do not apply until the instrument comes into force.
When the instrument comes into force, the below draft guidance will be removed from this page and the final guidance on our usual webpages will go live.
We appreciate your feedback on the draft guidance, for example where you consider information to be missing or where something is not clear. You can contact us on vmr@vmd.gov.uk if you have feedback or any questions.
If you require guidance on the current requirements under the Veterinary Medicines Regulations 2013, please review the veterinary medicines guidance on GOV.UK or see the Information Hub Explainers below.
Authorisation requirements
These draft guidance documents for the pharmaceutical industry reflect the changes related to marketing authorisations for veterinary medicines and registrations for homeopathic remedies. This includes changes related to applications for authorisations and registrations, labelling and packaging and animal test certificates.
- To follow: DRAFT labelling and packaging
Post-authorisation requirements
These draft guidance documents for the pharmaceutical industry reflect the changes related to variations to marketing authorisations and registrations of homeopathic remedies and post-authorisation monitoring (pharmacovigilance) of adverse events (which is also relevant to the holders of specific manufacturing authorisations).
Manufacturing
These draft guidance documents for the pharmaceutical industry, especially holders of (specific) manufacturing authorisations and manufacturers, importers or distributors of actives substances, and Feed Business Operators reflect the changes related to manufacturing (authorised) veterinary medicines, autogenous vaccines, products for administration under the cascade, active substances and medicated feedingstuffs, as well as authorisations for blood banks and stem cell centres.
Supply
These draft guidance documents for the pharmaceutical industry, wholesalers, distributors, prescribers and retailers reflect the changes related to the retail and wholesale supply of veterinary medicines, and advertising of veterinary medicines.
- To follow: DRAFT Known supply problems with animal medicines
Using medicines
These draft guidance documents for prescribers of veterinary medicines reflect the changes related to the prescribing of unauthorised veterinary medicines under the cascade and of antibiotic veterinary medicines.
Other
These draft guidance documents reflect the changes related to appeals against regulatory decisions by the VMD, fees set out in the Veterinary Medicines Regulations 2013 and the VMD’s Enforcement Policy.
Information Hub explainers - Still current following 11 March update
| 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 - 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. |
| 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 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 (SI) 2013/2033), as amended, remains 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 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.
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.
Last updated 19 April 2024 + show all updates
-
Revised Draft pdf added for Pharmacovigilance of Veterinary Medicines in GB with BRR template.
-
Updated Mitigation explainer: Labelling text - Product Information Templates
-
Draft Guidance attachments have been added for: * Marketing authorisations for veterinary medicines * Registrations for veterinary homeopathic remedies (VHR) * Technical annex * Variations to a veterinary marketing authorisation or homeopathic remedy * Exemption from authorisation for medicines for small pet animals * The cascade: prescribing unauthorised medicines
-
Updated to include Draft guidance reflecting changes to the VMR.
-
Removed references to Northern Ireland Protocol - now referred to as the Windsor Framework.
-
The Northern Ireland section under The Windsor Framework has been updated.
-
Updated to take into account of The Windsor Agreement.
-
European Commission Statement 19 December 2022 added: three-year extension to the grace period for veterinary medicines until 31 December 2025.
-
Northern Ireland update: Introduction of the Northern Ireland Protocol Bill
-
Updated to include information specifically for Vets in Northern Ireland. There is no change to the current cascade steps.
-
Update concerning Northern Ireland: EU Regulation 2019/6 and EU Regulation 2019/4 will not be implemented in Northern Ireland.
-
Northern Ireland update following Government statement 17 December
-
Explainer text added regarding the Government announcement about the 'standstill' arrangements for Northern Ireland.
-
Explainer text added regarding the Government announcement about maintaining the “standstill” arrangements.
-
links updated to expliners
-
Hub revamp - DM 1738370
-
End of Transition Period Information Hub launched
-
Recognition of MAH location, manufacturing sites and authorised personnel update
-
Added information on the Border Operating Model
-
Post-Transition period action deadlines extended
-
First published.