FOI - Librela adverse events
Published 30 October 2025
© Crown copyright 2025
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/vmd-foieir-requests-july-2025/foi-librela-adverse-events
ATI1088 Request
Would it be possible to get a dataset for all adverse drug reports submitted for Bedinvetmab and some comparator drugs
Our reply
In relation to the request for the dataset for all adverse drug reports submitted for Bedinvetmab and some comparator drugs, we want to be as open as possible in answering requests. However, we believe that your request is potentially very broad and gathering the information together could involve a diversion of resources from our other work. We have refused this request as you currently frame it under Section 12(1) of the FOIA because we estimate that the cost of complying with the request would exceed the appropriate limit, which currently stands at £600.
But we do want to help you obtain the information you are looking for if we can. If you were to make a new request for a narrower category of information, it may be that we could comply with that request within the appropriate limit, although I cannot guarantee that this will be the case. In reframing your request, it would help to narrow the list by specifying a particular type of adverse events and/or narrow the timeframe. For example, you could request a list of adverse events coded to Preferred Term (PT) level as per VeDDRA (VeDDRA (Veterinary Dictionary for Drug Regulatory Activities) for bedinvetmab and a specified comparator product. The list of PTs is likely to include events that have occurred within reports where more than one product was used (including events which may have occurred before one or more veterinary medicinal products were administered), when the product was used off-label, that is using a medicine in a way that is not specified on the product’s label, or reports where, on further evaluation, there may have been other reasons for the adverse event(s) occurring.