The European Medicines Agency has released guidance for applicants detailing the process for submitting electronic product information (ePI) in centralised procedures. This document provides practical instructions on how ePI should be prepared, submitted and maintained throughout the product lifecycle.
Who is affected by EMA’s ePI guidance for centralised procedures?
This update is most relevant to Regulatory Affairs professionals in pharmaceutical and biotechnology companies managing centrally authorised medicinal products in the EU. It affects both large companies and SMEs involved in MAAs and post-authorisation activities, particularly those responsible for product information management across the product lifecycle.
Why EMA’s ePI guidance matters for centralised procedure applicants
This guidance provides greater clarity on how ePI should be prepared, submitted and maintained for centrally authorised medicinal products. While ePI remains voluntary, it signals EMA’s direction towards more structured and digital product information management, making it important for companies to assess their readiness and integrate ePI considerations into future regulatory planning.
What EMA’s ePI guidance means for sponsors submitting product information
EMA’s ePI guidance is currently voluntary, which gives sponsors time to prepare before it becomes a requirement. To get ready, we recommend the following actions:
- Identify products and upcoming regulatory procedures where ePI could be implemented during the current voluntary phase.
- Establish ownership and governance processes to ensure ePI remains aligned with approved product information throughout the product lifecycle.
- Assess whether current systems and digital capabilities can support efficient ePI creation, maintenance and submission and seek regulatory expert support where additional expertise is needed.
Josephine Ingemarsson
MSc, Senior Consultant Regulatory Affairs
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