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e-PI: Electronic Product Information

Today Product information is available in pdf format. The epidemic has accelerated the digitalization of healthcare in Europe, and one aspect of digitalization is the use of electronic product information for human pharmaceuticals. ePI stands for electronic product information which refers to digital documentation or data that provides detailed information about a particular medicinal product. ePI will be electronic format structured information, not a simple document compared to pdf. The development of electronic product information (ePI) is intended to improve access to up-to-date product information on medicines when and where it is needed, facilitating the understanding of the benefits, risks, and instructions associated with a specific product by healthcare professionals, patients, and consumers. The EU product information for medicinal products consists of two main documents: the Summary of Product Characteristics (SmPC) and the Package Leaflet (PL), which are regulated regarding their content, structure, and layout. To be effective, ePI has to be actively referred to, read, understood, trusted, and remembered. The SmPC is primarily directed to Healthcare Professionals (HCPs), while the PL addresses patients and caregivers, requiring different language and layout principles to suit the reader.

The European Medicines Agency, in collaboration with Heads of Medicines Agencies and the European Commission, has developed key principles through stakeholder consultations to guide the development and use of ePI in the EU. Currently, ePI will be simple as it is a paper version. No additional information from master data and no extra resources in terms of software will be required. EMA portal is designed to upload or create ePI.

ePI will provide benefits to public health. Both patients and healthcare professionals will benefit from this change.

  • Creates efficiency gains for regulatory systems;
  • Aligns with the existing legislative framework and complements (or replaces) the paper package leaflet;
  • Fits into the EU’s multilingual environment. Patients would access product information in their mother language;
  • Interacts with other ongoing digital initiatives at EU and global level. ePI will be integrated into national healthcare systems, to have access to HCP. Eg. doctors during medicine electronic prescription would be immediately notified about product shortages;
  • Immediate implementation after variation with impact to product information update approval by National Competent Authority. The paper version of course will be accessible to patients much later in 3-6 months or even longer in case product stocks will circulate in the market;
  • ePI would prevent product recalls related to labeling in some cases. ePI will ensure that small editorial, but important mistakes would not result product recalls;
  • Increased accessibility to patients with diverse abilities;
  • Reduce product shortages by allowing redistribution of packs in different language;
  • Reduction in packaging/distribution waste arising from label changes and recall of batches.

These are only primary added values of ePI. Once the process will be fully launched, continuous improvement and integration will follow.

Now let’s look where we are and into important milestones related with ePI implementation. Pilot phase planned to start beginning in H2 of 2023. Pilot phase results will be ready and shared in Q1 of 2024. Later in 2024 ePI will be implemented for centralized approved products. Respectively version updates and control will follow. Speaking about national implementation at EU member states, it will be phased out and timeline will depend as per national guidelines.

For more information, do not hesitate to contact us.

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