EMA Publishes Guidance for Submitting Electronic Product Information (ePI)

AI-generated NewsSnap summary based on source reporting.
Published: 2026-09-08
Category: health
Source: RAPS

The European Medicines Agency (EMA) has released new guidance for companies on how to submit electronic product information (ePI) as part of marketing authorization applications. This guidance is a step towards the digital transition of product information, though ePI submission remains voluntary until new pharmaceutical legislation fully takes effect.

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