First publications of electronic medicines information (ePI)
The Heads of Medicines Agencies (HMAs), the European Commission (EC) and the European Medicines Agency (EMA) have published for the first time electronic medicines information (ePI) for selected harmonized medicinal products for human use across the European Union (EU).
The information on the medicinal product includes :
- Fact sheet
- Package leaflet
All these documents are available, in PDF format, on the websites of the EU regulatory authorities. The package leaflet can also be consulted physically, inside the carton, together with each medicine.
Digital platforms open up 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 ePI in real regulatory procedures is being explored through a year-long pilot initiative by the HMA, EMA and EC to enable the transition to the electronic system for assessed medicines at both national and European level. This initiative is an action under the Pharmaceutical Strategy for Europe supported by the EU funding program EU4Health.
The ePIs can be found on the product lifecycle management portal at the following link, https://plm-portal.ema.europa.eu/ePIAll/. These ePIs are in English for centrally approved medicines and in the local language for nationally approved medicines. Tests are underway to allow access to the ePIs in all EU languages.
In addition, ePI data can be accessed through a public application programming interface where developers can explore the potential of this new format within existing digital platforms
These ePIs were created following the common EU ePI standard adopted by the European medicines regulatory network to provide a consistent structure across Member States and ensure that the information works across different eHealth platforms. This should facilitate the use of product information to meet individual needs and access requirements. In the future, functionalities such as automatic notifications of updates, access to supporting video or audio content, and online adverse reaction reporting tools could be included.