Whitepaper: Monitoring Compliance with Safety Exchange Agreements
According to the new reforms, an economic operator can be a manufacturer, an authorised representative, an importer, or a distributor
According to the new reforms, an economic operator can be a manufacturer, an authorised representative, an importer, or a distributor
A Safety Data Exchange Agreement (SDEA) is a document that outlines the pharmacovigilance duties of two or more parties in a clear and concise manner. Typically, a SDEA will be between a marketing authorisation holder (MAH) and a thirdparty, such as a pharmacovigilance provider, distributor, medical information provider, manufacturer or co-marketing partner. It is sometimes otherwise known as a pharmacovigilance agreement (PVA).