Urgent and clinically significant safety updates for veterinary medicines
Source: gov.uk (2025-12-01)

Urgent and clinically significant safety updates arising from pharmacovigilance data, including reported adverse events, for veterinary medicines authorised in the UK.

Reporting an adverse event

An adverse event is any observation in animals, whether or not considered to be product-related, that is unfavourable and unintended and that occurs after any use of a veterinary medicine, whether off-label or on-label use. This include events related to a suspected lack of expected efficacy according to approved labelling or noxious reactions in humans after being exposed to a veterinary medicine.

If anyone becomes aware of an adverse event involving a veterinary medicine they can report this to the Marketing Authorisation Holder (MAH or pharmaceutical company).

The MAH for a UK-authorised medicine can be found on the product leaflet or by searching for the product on the Product Information Database (https://www.vmd.defra.gov.uk/ProductInformationDatabase/search).

To report a suspected adverse event to a human medicine or a product that you know is not an authorised veterinary medicine, please request a form from xxx@xxx.xx (mailto:xxx@xxx.xx), stating within your email that you are requesting the form in order to report an adverse event to a human medicine or to a product that you know is not an authorised veterinary medicinal product, as applicable.

The VMD’s pharmacovigilance team continuously monitors all adverse event reports that are submitted to the VMD and reports submitted directly to the MAH.

List of urgent and/or clinically significant safety updates

Urgent and/or clinically significant safety updates published by the VMD in the last 12 months.

SPC changes listed on this page may have been made as a result of routine rather than urgent pharmacovigilance processes. They include additions of Medically Important Terms (MITs), however. SPC changes involving non-MITs assessed as having a significant beneficial clinical impact may also be included. More detail can be found in our adverse event reporting guidance (https://www.gov.uk/government/publications/pharmacovigilance-of-veterinary-medicines-in-great-britain/adverse-event-reporting).

Other pharmacovigilance updates

Other pharmacovigilance updates from the VMD published in the last 12 months.

Additional information

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Further guidance on what veterinary pharmacovigilance is and who is responsible can be found in the guidance documents on gov.uk (https://www.gov.uk/government/publications/pharmacovigilance-of-veterinary-medicines-in-great-britain).

You will find the Summary of Product Characteristics (SPC) for all veterinary medicinal products authorised for marketing in the UK on our Product Information Database (https://www.vmd.defra.gov.uk/ProductInformationDatabase/)

No medicine is 100% risk free, the SPC includes information on what adverse events have been known to occur following administration of a particular product, these can be found in the section ‘Adverse events’ (3.6) or ‘Adverse reactions’ (4.6).

A rolling 6-month list of SPC changes for veterinary medicinal products is published on the Veterinary Practice and Supply page under the Medicine Updates section of VMD Connect (https://www.vmdconnect.uk/medicines-update).

Additional updates on veterinary pharmacovigilance in the UK can also be found on the adverse events page (https://www.vmdconnect.uk/adverse-events) of VMD Connect.

Explanation on the Calculation of adverse event incidence for veterinary medicines (https://www.gov.uk/guidance/calculation-of-adverse-event-incidence-for-veterinary-medicines)

Contact

If you have any questions regarding pharmacovigilance you can e-mail xxx@xxx.xx (mailto:xxx@xxx.xx)