Adverse Experience Reporting for Veterinary Medicines

What is an adverse experience?

An adverse experience is an unintended or unexpected effect on animals, human beings or the environment, including injury, sensitivity reactions or lack of efficacy associated with the clinical use of a veterinary chemical product.

A number of veterinary medicines have known side effects when used as directed. It is useful to records so that the true incidence of these side effects can be assessed. Furthermore, because of the enormous diversity amongst animal species and the relatively small number of veterinary medicines in the marketplace, it is occasionally necessary to use products in circumstances where there is limited information available on the dose rates and adverse reactions in "non-target species". Such products may have originally been intended for use in humans or other animal species. For this reason it is important to report all adverse experiences whether associated with label recommended dosing or not.

Who can report on an adverse experience?

Anyone. Members of the public, farmers, veterinarians, and other users of veterinary medicines are encouraged to report adverse experiences that have occurred with the use of or exposure to such products that have been used according to label or APVMA permit directions to both the APVMA and the product registrant.

About the Adverse Experience Reporting Program (AERP)

The APVMA’s Adverse Experience Reporting Program for veterinary medicines (AERP Vet) aims to ensure that products on the market remain safe, effective, are of acceptable quality and are used in the best possible way, and that instructions and warnings on labels are appropriate. Recording and investigating reports of adverse experiences is an important step in detecting unusual or rare conditions that were not evident in clinical or field trials and as a result, could not be assessed during the product registration process. The Program helps to ensure that products on the market

remain safe, effective and of acceptable quality,
are used in the best possible way, and
that instructions and warnings on the label are appropriate.

Key Documents

Contact

For adverse experiences with agricultural or veterinary chemicals
Phone: (02) 6210 4806 Fax: (02) 6210 4813 AERPCoordinator@apvma.gov.au