Question to the Department for Environment, Food and Rural Affairs:
To ask His Majesty's Government what assessment they have made of the adequacy of safety advice provided to users of the spot-on pet treatments containing fipronil.
The adequacy of safety advice provided to users of spot‑on veterinary medicines is assessed as part of the statutory authorisation process for veterinary medicinal products. The Veterinary Medicines Directorate (VMD) conducts a comprehensive user‑risk assessment in accordance with established international guidance, including the Committee for Veterinary Medicinal Products (CVMP) guideline on user safety for veterinary medicinal products (EMA/CVMP/543/03‑Rev.1) and the CVMP guideline specifically addressing topically administered products (EMA/CVMP/SWP/721059/2014).
These assessments consider both direct and indirect routes of exposure, including contact with treated animals. Where the assessment identifies potential risks, appropriate risk‑mitigation measures are implemented. These are reflected in the product information, including the Summary of Product Characteristics and the package leaflet, and typically comprise clear instructions on correct application, advice to minimise human contact with the application site, and warnings intended to protect vulnerable household members, including children.
The adequacy of this safety advice is kept under continual review through the VMD’s pharmacovigilance system, which monitors reports relating to user safety and allows updates to product information where required. Publicly available assessment reports and product literature can be accessed via the Product Information Database on GOV.UK.