Pilot Report on the Electronic Product Information (ePI)

Experience gained from creation of Electronic Product Information (ePI) during a pilot has recently been published in form of a report. The report outlines the outcomes of the pilot and derives learnings and recommendations that will inform the next steps towards introduction of ePI for EU medicines.

Background

The pilot, which involved EMA and the national authorities of Denmark (DKMA), Netherlands (MEB), Spain (AEMPS), and Sweden (MPA), together with industry, resulted in the publication of 23 ePIs from real regulatory procedures, of both centrally and nationally authorized medicines. The ePIs can be viewed at the Product Lifecycle Management (PLM) Portal.

The PI of a medicine includes its summary of product characteristics (SmPC), the labelling and the package leaflet (PL). These documents accompany every medicine authorized 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 EU regulators, with a printed PL usually also provided in the medicine’s box.

The introduction of product information in an electronic format (ePI) compatible with digital platforms opens new possibilities for patients and healthcare professionals to access and interact with vital, up-to-date information about their medicines.

Patient access to the electronic Package Leaflet (ePL)

A pre-requisite for successful adoption of harmonized ePI across the EU will be robust systems in place ensuring that the patient can easily access the electronic package leaflet (ePL) for their medicine. This will involve the following:

• Easy access to the ePL: A user-friendly solution, not requiring high levels of digital literacy, to link the patient from the medicine box in their hand to the ePL.
• Availability of a printed copy of the package leaflet: Provision of a printed PL in case the patient prefers to read the information on a paper copy.  

Implementation

Following ePI implementation, it will continually improve in several directions, including but not limited to:

• Extending the digital workflow Implementation towards a smoother and more coherent process of data management, including data capture, analysis, storage and dissemination.
• Developing advanced PLM portal functionalities and new features.
• Potentially widen the scope to incorporate future product types (e.g., parallel traded medicines, veterinary medicines).

For more information please see Successful pilot paves the way for implementation of ePI published on the EMA website.