First electronic product information published for medicines
Four EU countries – including Denmark – have published the first versions of digital product information for selected medicines. A pilot initiative is right now testing the use of digital product information for medicines used by citizens and healthcare professionals throughout the EU.
All medicines are supplied with a package leaflet and summary of product characteristics – usually in paper form – to ensure patients and healthcare professionals have access to needed information about, for example, correct use and dose recommendations.
The first digital versions of this important information have now been made accessible to the public in a new EU standard format – thanks to a pilot initiative with participation from the drug regulatory authorities in Denmark, Sweden, the Netherlands and Spain and the European Medicines Agency (EMA) and a number of pharmaceutical companies.
The first digital versions of product information for medicines, the so-called ePI (electronic product information), are accessible through a designated portal on the EMA website (see link below) in the local languages in question. Medicines authorised by the EMA as well as medicines authorised by national drug regulatory authorities are included.
The documents can be exported in Word format, and a so-called API solution has been developed to enable the download of documents from the portal to apps.
The digital platform for product information for medicines makes it easier and quicker to update the information about medicinal products and makes it more accessible to patients and healthcare professionals.
Pilot concludes in 2024
The pilot covers a total of 25 different medicinal products and will conclude in July 2024. The pilot will hereafter await its evaluation outcome. The experience gained is to serve as the basis for general recommendations on how ePI documents can be integrated into licensing processes across the entire EU.
Links
Read the announcement from the EMA, the national competent authorities and the European Commission
Read more about electronic product information (ePI) (including details about the EU common format (EU ePI Common Standard))
Read about the key principles of electronic product information for medicines (ePI) in the EU
See the list of the first digital product information for medicines