Paediatric Medicines Under the EU Legislative Reform
Published Oct 01, 2026
Changes to Electronic Product Information (ePI) in the EU under the EU Pharmaceutical Reform
Published 13th July 2026
The European regulatory framework for medicinal products is undergoing revision to reflect advances in scientific innovation, address unmet medical needs, and respond to the increasing complexity of modern pharmaceutical development. As part of this update, the recently agreed pharmaceutical legislation introduces changes to electronic Product Information (ePI).
Under the pharmaceutical reform, the European Union (EU) is steadily moving towards the digitisation of medicines information through the introduction of ePI. The changes towards ePI represents a fundamental shift in how authorised product information is created, maintained, and accessed across the EU medicines regulatory system.
electronic Product Information (ePI)
A medicine’s product information (PI) which includes the Summary of Product Characteristics (SmPC, intended for healthcare professionals [HCPs]), labelling (outer and inner packaging information) and package leaflet (PL, for patients/consumers and generally included as a printed copy in the medicines package (1)), is a pivotal source of regulated and scientifically validated information that assists HCPs in prescribing and dispensing the medicine and informs patients and consumers about its safe use (2).
e-labelling is the digital version of traditional printed product information, whereas the ePI is dynamic structured content that can be searched in real time and the end goal as this will facilitate integration of the information with e-health systems.
ePI initiative supports digital transformation of healthcare across the EU. The content remains legally identical to the approved product information but is formatted to enable digital handling, reuse, and dissemination via web platforms and e‑health systems.
Why is the EU moving towards ePI?
The move to ePI aligns with several EU policy objectives, including the European Commission’s Pharmaceutical Strategy for Europe, the EMA Regulatory Science Strategy, and broader digital‑health initiatives. Traditional paper leaflets and PDF documents can be difficult to search, slow to update, and not suited for digital healthcare environments.
ePI is intended to:
- Improve accessibility to up‑to‑date medicines information
- Enable multilingual delivery across the EU
- Support integration with electronic health records and prescribing systems
- Reduce the risk of patients and healthcare professionals relying on outdated information
Overview of the ePI pilot project
The ePI pilot was conducted by EMA in collaboration with national competent authorities from Denmark, the Netherlands, Spain, and Sweden, alongside industry participants. The pilot ran for one year (July 2023 – August 2024) and tested ePI creation and management during real regulatory procedures at both centralised and national levels. The pilot introduced the creation and management of ePI via the Product Lifecycle Management (PLM) Portal.
The PLM Portal and supporting guidance were generally considered usable by both regulators and industry, although the pilot identified areas where workflow efficiency and user guidance could be improved before large‑scale rollout.
The pilot reinforced that patient access to electronic package leaflets must be simple, intuitive, and inclusive. EMA has proposed solutions such as linking to ePI via 2D codes on outer packaging, while maintaining the availability of paper leaflets for those who need them.
Current ePI guidance and changes under the EU Pharmaceutical Reform
Based on the pilot, the EU pharmaceutical reform will bring in changes to the way product information is available, including:
- Patient Safety: The use of a user-friendly database for medicinal products which can be accessed by the public. The database can be used to search for product information including the electronic version of the packaging leaflet
- Flexibility: Member States have discretion on the adoption of measures enabling the exclusive use of ePI for either specific categories of medicines or all medicines. Where a PI is only available electronically, the paper version should be made available when requested (at no extra cost to the patient)
- Reporting Requirement: Where products are centrally authorised, the marketing authorisation holder should provide information concerning the Member States where the product is on the market
- Digital Access: Information must be easily accessible for patients by including a digitally readable element on the outer packaging e.g. QR codes, a data matrix code, or barcode
Examples of the different types of codes are represented below.
ePI implementation roadmap
The EMA’s had outlined a phased implementation approach beginning in 2026, with a gradual transition toward fully digitalised product information across the EU (see below). Voluntary adoption will start in late 2026 for vaccines, followed by oncology products in early 2027. All centrally authorised products will be able to voluntarily implement ePI within the second half of 2027. All ePI’s will be supported by a structured “hypercare” transition period. The roadmap for national competent authorities is still under discussion and will be rolled out late 2026/early 2027.
Early implementation will run alongside existing Word/PDF submissions, requiring applicants to author and upload ePI via the PLM portal as an additional step, without disrupting ongoing assessments. Over time, ePI is expected to become fully integrated into regulatory procedures, with multilingual capabilities and lifecycle maintenance for all variations.
Conclusion
The EU pharmaceutical reform introduces ePI, converting traditional documents into structured, readable formats that improve accessibility, searchability, and integration with digital systems. It establishes a harmonised EU approach with a central repository and multilingual access via the PLM Portal. Phased implementation will transition from voluntary to mandatory use, supporting fully digital regulatory processes and lifecycle management.
ePI is not just a regulatory update or an IT project – clear understanding of processes and governance is critical. MAH must ensure that their ePI is linked to correct data carrier identifiers (e.g. GTIN/NTIN/PPN), upload and maintain data via PLM portal, prepare for process changes to generate and maintain identifiers in advance of ePI publication and also prioritize accessibility, multilingual support, and non-promotional content.
DLRC can provide operational and submission support, including the authoring of compliant ePI and integration into regulatory workflows. During the transition phase, where ePI must be submitted alongside traditional formats via the PLM portal. For more information on upcoming changes with the EU pharmaceutical reform, reach out to learn more about DLRC’s EU Pharmaceutical Reform Insights Package. We can help you understand and prepare for the upcoming changes.
Contact us today at hello@dlrcgroup.com to discuss how DLRC’s award-winning consultants can help you throughout your product’s approval process.
