MEB starts pilot project to test electronic product information

The Medicines Evaluation Board (MEB) is starting a pilot project to generate an electronic format for medicinal product information (ePI). The aim of ePI is to improve the access to and user-friendliness of medicinal information,  such as the patient information leaflet, for patients and healthcare providers. Because the information will be electronic, the product information can be adjusted immediately when necessary, and even adapted to the individual needs of the user. The pilot is a collaboration between the MEB, the European Medicines Agency (EMA) and other medicines authorities.

Objective of the pilot project

During the ePI pilot project, the participating companies create the product information in electronic format. The MEB assesses the product information. Following approval, the ePI will become available for publication on websites, apps and healthcare information systems.

In. Prof. Dr. Ton de Boer, MEB chair:

The patient information leaflet provides patients with essential information on how to use their medicine. In today’s digital age, traditional print and PDF formats for medicinal product information are becoming less effective. Electronic product  information is more suited to the individual needs of the patient, gives healthcare providers up-to-date information faster and can therefore lead to better health outcomes.

Application of electronic product information

ePI enables new applications of medicinal product information. Information for healthcare providers and patients can be adjusted more quickly. It will become possible to rapidly update the ePI with the latest authorised information. ePI can also adapt the product information to individual needs, for instance by emphasising certain information such as side effects and interaction between medicines.

ePI will also facilitate the creation of product information that is more accessible to medicine users with print impairments. For example, blind and partially sighted people can have the text read aloud much more easily because of the electronic structure of ePI.

In order to ensure a smooth integration of ePI with the Dutch health information system, the MEB is conducting exploratory discussions with various healthcare parties in the Netherlands. This process involves examining the position of ePI within the Dutch healthcare data infrastructure and analysing data exchange scenarios to determine where ePI provides added value.

MEB and the medicines authorities 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.