Research and analysis

Further information on Post authorisation monitoring - Pharmacovigilance

Published 16 February 2026

1. Post authorisation monitoring

The VMD assesses the safety, quality and efficacy of veterinary medicines before and after authorisation to ensure that the benefit-risk balance remains positive.  The VMD’s Pharmacovigilance team monitors all reports of adverse events (both adverse reactions and lack of efficacy reports) from authorised veterinary medicinal products that are submitted to the VMD from veterinary professionals and animal owners. The Veterinary Medicines Regulations also requires Marketing Authorisation Holders (MAHs) to monitor and report on the benefit-risk of their veterinary medicines on a continuous basis, including reporting adverse events within 30 days of awareness. All reports received by the VMD are evaluated and where appropriate, actions based on available data may be taken – for example adding additional warnings on the packaging or changing the way a product is used.  

We would like to reassure veterinary professionals and dog owners that we are constantly reviewing adverse event report data to ensure that the overall benefits of each UK licensed veterinary medicine product outweighs the risk posed by their potential adverse events.

As with any veterinary medicinal product marketed in the UK, all strengths of Librela Solution for Injection for Dogs have been subject to continuous monitoring since it was first authorised, in November 2020.

2. Safety information on product literature

All medicines whether for human or animal use come with risk, and the benefits of use in wider populations need to outweigh the potential risks. The VMD does not publish specific adverse event data, however information on adverse events that have been known to occur following administration of a particular product are summarised in sections 3.6/4.6 of the Summary of Product Characteristics (SPC).  

3. About the SPC

The SPC is a document describing the properties and the officially approved conditions of use of a medicine. The SPC and associated product information are updated as new information is available, and the latest version of an SPC can be found on our publicly available Product Information Database.

The SPC and associated product information for Librela Solution for Injection for Dogs (all strengths), including a list of Post Authorisation Assessments that have occurred since the products were first authorised, can be found on this database.

It is important for veterinary professionals to ensure that this information is reviewed and discussed with the animal owner prior to administering the product in line with Section 11 of the RCVS Supporting Guidance for the Code of Professional Conduct for Veterinary Surgeons.

A rolling 6-month list of SPC changes for veterinary medicines can be found on the monthly medicines update page.

4. Jurisdictions

There may be differences in the data that appears on product information in different jurisdictions. Each jurisdiction follows specific legislation and guidelines which regulate the safety information to be included on the veterinary medicine label and information leaflet during the authorisation process and the procedures to change this label as necessary, once the medicine is placed on the market and following analysis of post-marketing pharmacovigilance data.

The current Veterinary Medicines Regulations can be found here: The Veterinary Medicines Regulation 2013 (legislation.gov.uk). The GB legislation is similar to that of comparative European countries.  

We do not comment on the regulatory decisions made by other jurisdictions or their regulatory processes.

5. How to report

Reporting adverse events is critical to increasing the volume of data available for ongoing monitoring to protect animal health, public health and the environment. We strongly encourage reporting of all adverse events by both veterinary professionals and animal owners, whether serious or non-serious.

To report an adverse event, we would advise veterinary professionals to contact the Marketing Authorisation Holder (MAH) (pharmaceutical company) for the product. and for animal owners to contact their veterinary practice and/or the MAH for the product.

The contact details for Zoetis UK Limited can be found in the product information that comes with Librela, and on the Product Information Database or at Contact us - Zoetis.

Ensure that alongside detailed information regarding the event, the relevant medical history, all concomitant medications, start date (and end date if applicable) of administration of Librela with dosage information, including frequency of dosing (and/or number of doses) are provided. We also recommend submitting detailed descriptions of imaging findings.

For orthopaedic cases, submission of an adverse event case to the MAH alongside provision of both pre-Librela imaging and imaging showing the adverse event is preferred; this enables the best quality data to be obtained.

6. Reporting to the VMD

Our online reporting form previously found on our Gov.uk website is unavailable. We apologise for any inconvenience caused. 

The VMD is developing an advanced online adverse event reporting portal, with implementation targeted for early 2026. This system will integrate with existing pharmacovigilance processes to provide more comprehensive safety oversight, and an enhanced and efficient process. Future updates on the new reporting portal will be published on our Gov.uk website.

7. Further information

• The VMD does not give individual clinical advice, as the specific treatment of an animal is best determined by the veterinary professional under whose care they fall. For advice on specific cases, general product advice or when considering off-label use, we advise veterinary professionals to contact the MAH.
• The VMD cannot help with complaints or concerns regarding the conduct of veterinary surgeons, including the way an animal has been treated using veterinary medicines. These concerns should be addressed to the Royal College of Veterinary Surgeons (RCVS).
• Pharmacovigilance updates are published on the gov.uk page, Urgent safety updates for veterinary medicines. This also includes any updates involving non-veterinary medicines used in animals. To receive these pharmacovigilance updates via email, please click on the ‘Get emails about this page’ button. In addition, changes to authorisations most relevant to vets are published monthly in the Vet Record (the official journal of the British Veterinary Association).