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 to come into force on 17 May
The Parliamentary debates on the draft Regulations, which will amend the Veterinary Medicines Regulations 2013 in respect of Great Britain, took place in April. Both Houses have now approved the Veterinary Medicines (Amendment etc.) Regulations 2024.
The new Regulations were made by Lord Douglas-Miller on 25 April 2024 and will be in force from 17 May 2024. You can find the legislation at: The Veterinary Medicines (Amendment etc.) Regulations 2024 (legislation.gov.uk).
We will update our guidance documents to reflect the new Regulations shortly before or on 17 May. We will communicate this through our usual channels.
Draft guidance for upcoming changes to legislation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 We have published the draft guidance to aid you in your consideration of the upcoming changes to the Veterinary Medicines Regulations 2013 (VMR) in respect of Great Britain.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 Regulations 2024 and the draft guidance set out below do not apply until the instrument comes into force.
When the instrument comes into force, the below draft guidance will be removed from this page and the final guidance on our usual webpages will go live.
We appreciate your feedback on the draft guidance, for example where you consider information to be missing or where something is not clear.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
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.
Draft guidance
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.
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 vaccin