The current draft key principles for ePI are the result of the consultations held throughout 2018 between the EMA, the Heads of Medicines Agencies (HMA), the European Commission and stakeholder representatives.
The main objective of sharing electronic product information for human medicines is to better respond to patients’ and healthcare professionals’ needs by making product information readily available and up-to-date, in an additional format to the printed versions. This product information specifically includes the package leaflet for patients and the summary of product characteristics for healthcare professionals.
It is worth noting that ePI:
- will not supersede or negate the requirements of pharmaceutical legislation to include a package leaflet in the packaging of all medicines or to directly convey all information required on the outer or immediate packaging;
- does not involve any changes to the content of the PI;
- will not replace the paper format;
- and will not constitute a new legal obligation, since the current legislation does not require the use of an electronic version of the PI. In other words, the use of ePI in addition to the current inclusion of the package leaflet will be a recommended but not mandatory innovation.
The comments submitted will be taken into consideration in regards the final version of the above-mentioned key principles for ePI, with a view to EU-wide harmonization in the field of electronic product information for human medicines.