FOI2026/00516 - Librela Safety Assessments, Internal Communications and Meeting Records
Published 10 June 2026
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1. Your request
Under the Freedom of Information Act 2000, I request the following information relating to the veterinary medicinal product Librela (bedinvetmab) and communications between the Veterinary Medicines Directorate and Zoetis during the last twelve years.
Internal safety assessments
Please provide copies of:
a) Any internal risk assessments, safety evaluations, or pharmacovigilance reviews conducted by the Veterinary Medicines Directorate relating to Librela, Solensia, Lenivia, Portela. (Northern Ireland and/ or UK)
b) Any internal reports assessing adverse event data associated with Librela + Solensia.
Correspondence with the manufacturer
Please provide copies of:
a) Correspondence between the Veterinary Medicines Directorate and Zoetis relating to safety concerns, adverse events, or pharmacovigilance data for Librela, Solensia, Lenivia + Portela.
b) Communications relating to risk mitigation measures, label changes, warnings, or safety investigations.
Meeting records
Please provide:
a)Minutes, summaries, or records of meetings where Librela, Solenisa, Lenivia, Portela safety concerns or adverse event reports were discussed by the Veterinary Medicines Directorate.
b) Any records of meetings or teleconferences between the Veterinary Medicines Directorate and Zoetis where Librela, Solensia, Lenivia, Portela safety was discussed.
Adverse event data reviews
Please provide:
a) Documents summarising adverse event reports received by the Veterinary Medicines Directorate relating to Librela + Solensia including internal analyses or summaries prepared by the regulator.
b) Any risk-benefit reassessments conducted after significant adverse event reports.
External expert advice
Please provide:
a) Any external expert opinions, advisory reports, or independent assessments commissioned by the Veterinary Medicines Directorate relating to Librela, Solensia, Lenivia, Portela safety.
b) The names or affiliations of external organisations or experts consulted.
2. Our reply
We are refusing your request under section 14(1) of the Freedom of Information Act 2000, on the basis that the request is vexatious.
FOIA does not require public authorities to comply with a request where doing so would impose a disproportionate or unjustified burden, or where the request forms part of a pattern of requests that collectively create an excessive strain on resources. The ICO explains that vexatious requests are those that have “the potential to cause a disproportionate or unjustified level of disruption, irritation or distress” to a public authority, emphasising that the purpose of section 14 is to prevent public resources being “squandered on disproportionate use of FOIA”.
This request is part of a wider pattern of very broad and highly detailed requests submitted by the same requester group over an extended period, seeking extensive operational, regulatory and staff related data.
ICO guidance confirms that the context and history of previous related requests is relevant when deciding whether a request is vexatious, and that repeated or overlapping requests can demonstrate an unreasonable burden on the authority’s resources.
Where possible, we have provided relevant information that is already, or will be, publicly available or in response to previous FOIs requests. Given the limited additional public value that further disclosure would provide, and the disproportionate resource impact of processing an expansive request of this nature, maintaining the refusal under section 14(1) is appropriate and necessary to protect the organisation from unreasonable use of FOIA resources.
Given the volume and nature of previous requests on this subject, further requests of a similar nature are likely to be considered vexatious under Section 14(1). However, each request will be considered individually in line with FOIA.
2.1 Requests relating to the approval process and post authorisation surveillance
Attached is a copy of our response to previous FOI requests FOI2025/00333 and FOI2026/00108 which explains the approval process and post authorisation surveillance. You may also find this information useful: Further information on Post authorisation monitoring - Pharmacovigilance - GOV.UK.
2.2 Requests relating to reported suspected adverse events
We have answered many FOI requests of this nature. These will be published on our disclosure log: Transparency and freedom of information releases - GOV.UK in due course.
On 16 February 2026, we published an in-depth assessment of adverse event reports relating to Librela, covering death, arthritis progression, and human exposure. This sets out our findings and the evidence base for our current position in full, and we would encourage you to read this and a statement from our Director of Authorisations on this assessment: In-depth assessment of selected adverse events for ‘Librela Solution for Injection for Dogs’ - GOV.UK, Regulator completes in-depth assessment of osteoarthritis pain relief injections for dogs - GOV.UK.