FOI2026/00267 – Annual benefit-risk reports (BRRs) from MAHs
Published 22 May 2026
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Your request
Please provide the annual completed benefit-risk reports (BRRs) provided by the Marketing Authorisation Holders (MAHs) for all spot-on pet treatments containing fipronil and imidacloprid. These to cover the last seven years from 2018 to 2025/26.
Our reply
Benefit-risk reports in the form you have requested only came into effect with the introduction of the new Veterinary Medicines Regulations (VMRs) from May 2024.
Prior to these changes, Marketing Authorisation Holders (MAHs) were not required to submit BRRs; instead, they were required to submit Periodic Safety Update Reports (PSURs), produced under the previous regulatory framework. As such, we do not hold BRRs for the years before the new VMRs came into force. For the period 2018 up to the introduction of BRRs, we hold PSURs rather than BRRs.
Your request covers 7 years of data (2018–2025/26) and applies to all spot-on products containing fipronil and/or imidacloprid. There are currently 681 authorised products across these categories, many of which are essentially similar in composition and regulatory characteristics. Providing all BRRs and all PSURs for earlier years would therefore require the retrieval, review, redaction (commercial sensitivity) and preparation of a very large number of documents.
Carrying out this volume of work would exceed the appropriate time limit set under Section 12 of the Freedom of Information Act, and we are therefore refusing the request on the basis that compliance would exceed the cost/time threshold.
We estimate that the cost of determining whether we hold the information, locating, retrieving and extracting it would exceed the appropriate limit. For central government bodies, this limit is £600, calculated at a flat rate of £25 per hour (24 staff hours). In this case, due to the number of products involved and the volume of reports (37 BRRs and around 550 PSURs), we estimate that complying with your request in full would exceed that limit.
How we can help you refine your request
To assist you in receiving meaningful information within the permitted time, we would be able to provide only the Benefit–Risk Statement of each of the 37 BRRs we have, which contains:
- the product information (product group code and, where applicable, product name)
- the period covered by the report
- whether any signals were submitted during the reporting period
- whether the MAH considers the benefit–risk balance to remain positive
To proceed
If you choose the narrowing option outlined above, we will be able to continue processing your request under new FOI reference number.
If you decide not to refine your request in this way, you may instead submit a new, narrower FOI request that limits the scope to a smaller set of products, years, or specific information fields. This new request would allow us to consider the revised scope afresh and determine whether it can be completed within the FOIA cost and time thresholds.