FOI release

FOI ATI1144 - Product authorisation and classification

Published 5 February 2026

1. ATI1144 Request

Request for all documents relating to product authorisation and classification that contain the research findings, data and evidence used to inform the VMD risk benefit analysis and conclusions relating to spot on pet treatments containing fipronil.

Specifically, those providing evidence of the human health benefits of routine, monthly prophylactic use of these treatments. This to include documents providing data that compares the human health risk and benefits for pet owners that treat their pets every month for fleas and ticks prophylactically with those that only treat if fleas and/or tricks are shown to be present on their pets or don’t treat at all.

2. Our reply

The proprietary data from trials carried out during the development of a product are commercially sensitive information. We judge that the Section 43 exemption of the Freedom of Information Act, information that constitutes a trade secret or would, or would be likely to, prejudice commercial interests, applies in this case. After careful consideration we conclude that the public interest in withholding the information strongly outweighs that for disclosure.

The information that we can provide can be found on the Product Information Database (Check if an animal medicine is licensed - GOV.UK) which includes a Public Assessment Report for each product. A public assessment report is a public document that provides a scientific summary of how a veterinary medicine was evaluated for approval in the UK. It includes the grounds for the decision on whether to grant or refuse a marketing authorisation, based on the applicant’s submitted data on quality, safety, and efficacy.

Nonetheless, the following general information may be helpful in understanding the current situation:

Veterinary Medicinal Products (VMPs) undergo a thorough assessment by the Veterinary Medicines Directorate (VMD) before they are authorised for marketing in the UK. This includes a product-specific user risk assessment that considers all those that may come into contact with the medicine, including adults and children. This assessment considers the identified hazards of the medicine, the likely exposure to adults and children when VMPs are used as recommended and concludes on the likely risks to humans. The identified risks are mitigated using appropriate packaging and user safety warnings on the product information supplied with the medicines. Once authorised for marketing, pharmacovigilance reporting provides further data from use of these medicines in real-world situations, and these data are used to consider any changes required to reduce identified risks, such as updating the user safety warnings. All VMPs are authorised based on a Benefit:Risk assessment, which accounts for the therapeutic benefits to the treated animals, the potential for reduction of zoonotic diseases in humans, and the possible risks identified to humans and animals. The benefits must outweigh the risks before a product can be authorised and may be removed from the market if shown that this is not the case after authorisation.

It should be noted that there is no requirement for pharmaceutical companies to provide data to compare different treatment regimens with regard to human safety. The requirement is to address reasonable worst-case exposure scenarios, in line with guidelines EMA/CVMP/SWP/721059/2014 and EMA/CVMP/543/03-Rev.1, published by the European Medicines Agency (EMA). Treatment schedules are the remit of the prescribing vet, in the case where a prescription is required. Where a prescription is not required, there is no recommendation on the product literature to treat each and every month; it advises that the minimum time between treatments is 4 weeks, and so it is up to pet owners to treat their pets as needed.