Overview of the pilot for the use of European Pharmacopoeia Medicinal Products and Electronic Information (ePI)

Table of Contents Executive summary........................................................................................................................................3Introduction...................................................................................................................................................5Methodology of the Survey............................................................................................................................6Results...........................................................................................................................................................7Some graphics about the main results of the survey...................................................................................7 Caveat:.The cut-off date for the results of the survey presented in this document is the end of Q2 2025. Since thatdate, there have been some development and evolution about the ePI pilots in Ireland, in Germany, … However, thesehave not been taken into accountin the presented results in order to have one single cut-off date for the statistical Executive summary In accordance with the current European legislation, a paper leaflet must be included in each pack of amedicinal product. This leaflet contains important information and guidance on the proper use of the The European pharmaceutical legislation is currently under review. The proposed revision includes theintroduction of electronic patient information (ePI) and creates the possibility for the future transition from The Inter Association Task Forceon ePI(IATF-ePI:AESGP,Efpia, Medicines for Europe) conducted a survey onthe status of ePI pilot projects across Europe. These pilotsare run by the national competent authorities,approved by the European Commission where necessary, and areconducted in collaboration with nationalstakeholders. Theyaim to prepare Member States, pharmaceuticalindustry, healthcare professionals (HCPs), The report provides an in-depth overview of ePI pilots in 31 European countries, highlighting the progressmade, challenges faced, and key insights gained from these initiatives. The findings underscore the potential The report emphasizes the importance of sharing knowledge and best practices from successful pilots tosupport countries that have yet to launch ePI initiatives. Insights from ongoing pilots demonstrate that ePI can This report showcases the progress made in implementing ePI across Europe and highlights the critical need KEY FINDINGS FROM THE REPORT: •ePI Pilots in Action: oFourteen countries, including Belgium, France, Portugal, and the Nordic region, are actively runningePI pilot projects.oSeven additional countries, such as Austria, Germany, and Cyprus, are in the planning stages oflaunching pilots. •Nordic Collaboration: oThe Nordic pilot (Finland, Denmark, Norway, Sweden, and Iceland) adopts a unique approach byallowing English-only outer packagingand labelling,while providing ePI in local languages. This •Positive Outcomes: oBelgium/Luxembourg: After a seven-year pilot, 97% of hospital pharmacists confirmed that theabsence of paper PILs caused no inconvenience in their daily practice, and 100% reported no issues for physicians.oPortugal: A survey of healthcare professionals after one year of piloting revealed strong support for ePI, •Countries Without Pilots:oTen countries, including Bulgaria, Hungary, and Italy, have not yet initiated ePI pilots, citing legal, Introduction Each pack of a medicinal product contains a paper leaflet. This leaflet contains important information andguidance on the proper use of the respective medicinal product,approved by the competent regulatoryauthorities.This is in accordance with the current European legislation,which states that apaper leaflet must The European pharmaceutical legislation is currently under review. The proposed revision includes theintroduction of electronicproductinformation(ePI)and creates the possibility for the future transition frompaper leaflets toePI. A gradual transition to theePI, driven by Member States' readiness, is proposed. EMA has conducted apilot exploring thesystem forcreation and testing ofePIs(standardizedelectronicproduct information) in real regulatory procedures. The report for this pilot is currently available.i Moreoverpilot projects (ePI pilots) have been set-upby the national competent authoritiesin several countries(and even including European approval where necessary), or are being planned in thenear future.This istoensure the readiness of Member States, the general population and the healthcare professionals, to phasing This report aims to provide an overview of whether, when, and under which conditions ePI pilots are conductedin 31 European countries. It should be noted that the pilot conducted in the Nordics (Finland, Denmark,Norway, Sweden, Iceland) is slightly different in its objective from the other planned or ongoing pilots inEurope. In the No