The provision of the ePIL to citizens and to health professionals requires that these documents are existing and accessible.
This is today only partially true:
- The EMA database for centrally approved products is comprehensive but consists of single PDF documents that gather the summary of product characteristics, the labels and the patient information leaflet. These documents are large (hundreds of pages) and not usable by non-specialists.
- Standalone ePILs can be found on several national authorities’ portals, but only for nationally approved vaccines.
- The new EMA Product Lifecycle Management portal would provide the product information in a semi-structured way, allowing to recompose the ePIL. At the time of writing (May 2026) its content is limited to 19 medicinal products, including only one vaccine, but the EMA’s recently published ePI roadmap indicates that further vaccines could be incorporated on a voluntary basis from the last quarter of 2026.
The mechanisms described in this implementation for accessing the Patient Information Leaflet could be reused for a variety of other vaccine related documents, such as:
- Summary of Product Characteristics
- Pharmacovigilance alerts
- Synthetic disease related information (similar to the Vaccine Information Statements released by the US CDC).