First electronic product information (ePI) published
The Medicines Evaluation Board (MEB), in collaboration with 4 other medicines agencies, has published the first electronic product information (ePI). The new electronic format aims to enhance the accessibility and usability of medicine information, including patient information leaflets, for both patients and healthcare professionals.
The product information of a medicine includes its summary of product characteristics, labelling and patient information leaflet. These documents accompany every medicine authorised in the EU and explain how they should be prescribed and used. They can be found, often as a PDF document, on the websites of medicines agencies with a printed patient information leaflet also provided in the medicine’s box. Digital platforms open new possibilities to share this information electronically, keep it constantly updated and make it more accessible to end-users such as healthcare professionals and patients.
The creation and testing of ePIs in real regulatory procedures is being explored through a one-year pilot initiative together with other medicines agencies in Europe. These ePIs were created following the EU ePI Common Standard, adopted by the European medicines regulatory network to provide a consistent structure throughout the EU and to ensure the information works across different e-health platforms.
Erol Hofmans, ePI project manager:
With the introduction of ePI, we are forging a vital connection between regulatory authorities and healthcare, while paving the way for a future where medicine information is more tailored to the specific needs of patients and healthcare professionals alike."
Objective of the pilot project
During the ePI pilot project, the participating companies create the product information in electronic format. The MEB assesses and publishes the product information.
MEB and the medicines agencies of Spain, Sweden and Denmark are conducting pilots for a small number of national regulatory procedures. The European Medicines Agency (EMA) is coordinating the project and is conducting a pilot for centralised procedures.
In the future, the ePI will become available for publication on websites, apps and healthcare information systems. The ePI data can already be accessed via a public application programming interface (API) where developers can explore the potential of the new format within existing digital platforms.