Select Page

Following the European Medicines Agency (EMA) and the European Commission and Heads of Medicines Agencies’ (HMA) release of principles outlining a standardized approach to electronic product information (ePI) last year, the EMA is holding a stakeholder consultation to launch a draft on EU common standard for electronic product information (ePI) this week. The common standard would provide guidance for ePI containing product information, as well as product characteristics (SmPC), labeling and package booklet. In order to discuss the standard and its future use, the EMA will be hosting a series of virtual workshops. The workshops will focus on the needs of users and enable the access, viewing and dissemination of product information in an electronic format.

Read more here

More on: