Periodic Safety Update Report
Periodic safety update reports (PSURs) provide an overview of the worldwide safety experience of a medicine during a defined period. They are prepared for each authorized veterinary medicine by the marketing authorization holder (MAH). We use the information in PSURs to continuously assess the benefit-risk balance of the veterinary medicine after they have been authorized for use.
In accordance with EU legislation (Directive 2001/82/EC as amended), a PSUR should include information on all adverse events (AEs) that occurred after use of the veterinary medicine during the reporting period. Detailed information on the content and structure of PSURs can be found in Volume 9B of the Rules Governing Medicinal Products in the European Union.