ADVERSE REACTIONS
 

Introduction

The Suspected Adverse Reaction Surveillance Scheme (SARSS) is a national surveillance scheme run by the Veterinary Medicines Directorate (VMD). The scheme aims to record and monitor reports of suspected adverse reactions to veterinary medicines in both animals (any species) and humans.

An animal suspected adverse reaction (SAR) is a harmful and unintended reaction which may be due to exposure to a veterinary medicine administered to an animal at its normal dose. In other words, it is any harmful side effect to a veterinary medicine. A reaction may occur in an animal undergoing treatment or in an untreated animal in the same household as a treated animal. A human SAR may occur in a person administering a veterinary medicinal product, or a person exposed to a recently treated animal. 

A Company which holds a marketing authorisation (the MA holder) is legally required to report serious adverse reactions within 15 days of receiving a report and non-serious adverse reactions in Periodic Safety Update Reports (PSURs) submitted at intervals specified in the Marketing Authorisation. Guidance for MA holders in the UK is provided in Veterinary Medicines Guidance Note 13 and via the VMD publication entitled MAVIS which is published quarterly.  Further guidance for MA holders is available from the EMEA (see the European Medicines Evaluation Agency (EMEA) website.)

If you would like to report a suspected adverse reaction, you can download the relevant form from the 'Forms' section of this website and send it in using our freepost address:

Department for Environment, Food and Rural Affairs (Defra)

Veterinary Medicines Directorate

FREEPOST KT 4503

Woodham Lane

New Haw

Addlestone

SURREY

KT15 3BR

If you cannot download a leaflet or form, or if you require further information on the scheme or adverse reaction reporting, please contact Denise Burge on 01932 338427.

More information on the scheme and on how to report a SAR can be found in the 'Publications' section of this website, notably the SARSS brochure.  You can also look up the Frequently Asked Questions Section.

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