Costanza Vignoli -

The European Medicines Agency (EMA) and its European medicines regulatory network partners are working to enable the use of electronic Product Information (ePI) for human medicines in the European Union (EU), which will not imply any changes to the PI content.

Transitioning to ePI will offer advantages such as improved accessibility, searchability and multilingual capabilities. Moreover, ePI can also integrate with electronic healthcare systems, enabling healthcare professionals and patients to access accurate and up-to-date product information more conveniently.

At the moment, EMA and a group of EU National Competent Authorities (participating countries include Denmark, the Netherlands, Spain and Sweden.) are planning to test the use of ePI in a one-year pilot project from July 2023.

Timelines and processes for the ePI implementation will be flexible and amenable to the available resources and priorities at national level. A roadmap will be proposed by Heads of Medicines Agency (HMA) and EMA to define the steps for development.

Regulatory Pharma Net provides full regulatory assistance during the whole product lifecycle and is ready to support companies on all regulatory needs and to guide them through any new EMA requirement/procedure.

Comments are closed for this post.