EMA publishes guidance on voluntary electronic product information submissions for EU MAAs

The European Medicines Agency released new guidance detailing how companies should provide electronic product information (ePI) when filing marketing authorization applications under the EU's centralized procedure.

The guidance notes that ePI submission is currently voluntary, pending full implementation of the EU pharmaceutical legislation that will later make it mandatory.

Companies are encouraged to follow the recommendations to prepare for the upcoming requirement, which aims to streamline product information access across the European market.