A harmonised approach to electronic product information (ePI)

In 2017, the European Commission (EC) identified electronic product information (ePI) as a means of improving how EU citizens access information about medicines. They have now released a set of principles to harmonise this approach.

Currently, all medicines authorised in the EU are accompanied by product information (PI), consisting of a paper package leaflet inside the medicine box, and a summary of product characteristics (SmPC), which can be accessed online by health-care professionals (HCP). Some medicines have electronic package leaflets available, however the European Medicines Agency (EMA) says that these are not inter-operable with other electronic health systems.

Therefore, the EC, in collaboration with the EMA and Heads of Medicines Agency (HMA) have outlined the key principles of ePI. The document released defines ePI as “authorised, statutory product information for medicines (i.e. SmPC, PL and labelling) in a semi-structured format created using the common EU electronic standard. ePI is adapted for electronic handling and allows dissemination via the world wide web, e-platforms and print”.

ePI is a public-health priority because it will expand the dissemination of unbiased, up-to-date, regulator-approved PI for all medicines in the EU. ePI will support, among other functions:

  • provision of the latest information on a medicine’s safety, benefits and conditions of use;
  • better delivery of information so that the right information is available to the right HCP and patient / consumer at the point of need;
  • informed decision-making by patients / consumers and HCPs.”

ePI would support all official EU languages. However, the document also suggests that providing ePI would not be a legal obligation as it is not required under current EU legislation. It would not supersede package leaflets and information on the outer and inner packaging.

In summary, ePI would benefit patients by making updated PI available more quickly and allow for enhanced accessibility for patients with disabilities. A common electronic standard would benefit patients and also increase regulatory efficiency, all the while complying with existing legislation for PI.

For more detail on the key principles, click here.