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 receiveemail alertsfor 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 The draft guidance previously published on this page has now been removed to avoid confusion.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 | The VMR 2013 (as amended) Pharmacovigilance Implementation Explainer will be published soon. |
| 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 regardingthe Windsor Framework.
On 31 January 2024, the government published a Command Paper. This paper sets out a range of measures that would bind Northern Irelands 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 Governments 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 followingstatement 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 towindsorframework@vmd.gov.ukand 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 an