Veterinary Medicines Directorate
VMD Information Hub
This is the Hub for all the Veterinary Medicines Directorates 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. 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, 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 the Windsor Framework.
As per the agreement in December 2022, the cliff edge on vet meds has been removed, protecting the supply of veterinary medicines in Northern Ireland through to 2025 whilst we work through a sustainable, long-term solution. 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 clear that a solution must guarantee the existing and long-established flows of trade between Great Britain and Northern Ireland on which so many people and businesses rely.
European Commission Statement 19 December 2022
On 19 December 2022, the European Commission issued the following statement by Vice-President Maro ef?ovi? 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 niprotocol@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 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.
Legal controls on veterinary medicines
The Veterinary Medicines Regulations (VMR) 2013 (Statutor