GovWire

Guidance: VMD Information Hub

Veterinary Medicines Directorate

March 27
18:47 2024

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.

Draft guidance for upcoming changes to legislation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 We have published the draft guidance to aid you in your consideration of the upcoming changes to the Veterinary Medicines Regulations 2013 (VMR) in respect of Great Britain.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 Regulations 2024 and the draft guidance set out below do not apply until the instrument comes into force.

When the instrument comes into force, the below draft guidance will be removed from this page and the final guidance on our usual webpages will go live.

We appreciate your feedback on the draft guidance, for example where you consider information to be missing or where something is not clear.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These draft guidance documents for the pharmaceutical industry reflect the changes related to marketing authorisations for veterinary medicines and registrations for homeopathic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.

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These draft guidance documents for the pharmaceutical industry reflect the changes related to variations to marketing authorisations and registrations of homeopathic remedies and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These draft guidance documents for the pharmaceutical industry, especially holders of (specific) manufacturing authorisations and manufacturers, importers or distributors of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.

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