If not yet done, please complete the conversion of your account to email authentication as soon as possible, by visiting My Account portal to login and follow the detailed instructions.
A reflection paper, currently open for public consultation, outlines considerations for linking to ePI by scanning a code on the medicine package. Comments can be submitted before end June 2025.
EMA has introduced email address authentication for EMA applications to improve security and usability of EMA applications by removing the need for users to remember their EMA username and password.
The ePI Pilot Report is now available, marking a significant step toward harmonised electronic Product Information in Europe. Highlighting key recommendations and progress, the report builds on the successful publication of 23 ePIs under the EU ePI Common Standard as part of the ePI pilot. The ePI aims to advance digital access to accurate medicines information.
All new self-registered users are automatically set by default to email authentication.
All users not converted are requested to opt-in before 20 January 2025.
Starting from 20 January 2025 the EMA will initiate the conversion of all users that didn’t opt-in to the email authentication:
- 20 January: Non regulatory users without specific application roles;
- 3 February: Non regulatory users with application roles;
- 3 March: Regulatory users (European Medicines regulatory Network);
- 31 March: all users are converted.
How to opt in: Users are required to opt-in to email authentication in EMA Account Management by following the enclosed detailed instructions. Once converted to email authentication, users can use email address to authenticate into EMA systems, as shown in figure below.
Useful links:
- Public system demo (Q3 2024) - Presentation and recording;
- "EMA Account Management - What's new" webinar recording
Contact: EMA Service Desk; If you are unable to access Service Desk, please send an email to servicenow@ema.europa.eu indicating your name, surname and your unique username.
The ePI pilot, launched in July 2023 has concluded after the publication of 23 ePIs in the course of live regulatory procedures for centrally and nationally authorised medicines.
2024/09/02 - Two new ePI NCA SMEs appointed
In a significant step harnessing the collaboration and expertise within the European Medicines Regulatory Network, two new subject matter experts have been appointed to the ePI team. One expert from AIFA in Italy and one from BfArM in Germany will join the current SMEs from Denmark and Sweden.
2024/07/22 - FHIR Implementation Guide for ePI - Now Live
The European Medicines Regulatory Network has published a FHIR Implementation Guide. The guide offers technical details on the FHIR standard, enabling medicine information providers to create harmonised ePI according to the EU ePI Common Standard. Harmonised ePI will help deliver up-to-date medicines information to patients and healthcare professionals across Europe in an accessible electronic format.
ePI refers to the authorised, statutory product information for medicines adapted for handling in an electronic format for dissemination via the web, e-platforms and in print. Generally, product information includes the summary of product characteristics, package leaflet and labelling.
The EU ePI Common Standard has been adopted by the European Medicines Regulatory Network. It is based on FHIR - https://www.hl7.org/fhir/overview.htmlFast Healthcare Interoperability Resources, an international set of guidelines for exchanging electronic healthcare data.
This Guide contributes to the European Medicines Regulatory Network commitment to deliver medicines information to patients and healthcare professionals in a harmonised electronic format, accessible to all.
2024/05/31 - Sweden and the Netherlands complete their ePI pilots
The Dutch Medicines Agency (Medicines Evaluation Board) and the Swedish Medicines Agency (Medical Products Agency) have now published electronic product information, ePI, for their regulatory procedures in scope for the one-year pilot initiative by European Medicines Regulatory Network (a total of 5 procedures for each authority). The published ePIs can be viewed at the PLM Portal and ePI data can be accessed via a public application programming interface.
The pilot aims to create and test ePI in regulatory procedures and is an important step towards providing medicines information for patients and healthcare professionals in an accessible, electronic, format.
Pilot procedures are still ongoing at EMA and the national authorities in Denmark. The pilot will conclude in July 2024 and the outcomes will inform progress towards implementation of ePI.
More information on the pilot is available at EMA, MEB and MPA websites.
EMA has updated the format and look of the landing page of the PLM Portal.
The new format aims to better reflect the different services available through the PLM Portal. The electronic Applications Forms (eAF) are now joined by the Product management Service (PMS) user interface and the electronic Product Information (ePI) submissions. The aim is also to make it easier to navigate to news and release notes for each service.
Furthermore, the new look is an initial response to the need for a more unified user experience. This is a need born out of the EMA PLM Value Stream’s ongoing investigation into opportunities to improve that user experience.
Share your thoughts on the new look on the PLM Forum.
2024/04/17 - Spain completes the ePI pilot
The Spanish Medicines Agency (Agencia Española de Medicamentos y Productos Sanitarios) has published electronic product information, ePI, for all regulatory procedures in scope for a one-year pilot initiative by European Medicines Regulatory Network. The pilot is to create and test ePI in regulatory procedures. This is a step towards providing information for patients and healthcare professionals in an accessible, electronic, format for medicines.
ePI refers to the authorised, statutory product information for medicines handling in an electronic format for dissemination via the web, e-platforms and in print. Product information includes the summary of product characteristics, the package leaflet and labelling. However the ePI format offers advantages such as improved accessibility, searchability and multilingual capabilities. ePI can also integrate with electronic healthcare systems, enabling healthcare professionals and patients to access accurate and up-to-date product information more conveniently.
The creation and testing of ePI in real regulatory procedures is being explored through a one-year pilot initiative by European Medicines Regulatory Network (EMRN). EMRN includes HMA (Heads of Medicines Agency), EMA and the European Commission (EC). The ePI initiative is an action under the Pharmaceutical Strategy for Europe supported by the EU funding programme EU4Health.
The pilot has published ePI for selected human medicines harmonised across the European Union (EU) for the first time in November 2023. ePI can be viewed at the PLM Portal and ePI data can be accessed via a public application programming interface.
Pilot procedures are still ongoing at EMA and the national authorities in Denmark, the Netherlands, and Sweden. The pilot will conclude in July 2024 and the outcomes will inform the path towards full implementation.
The Heads of Medicines Agencies (HMA), the European Commission (EC) and EMA have published for the first time electronic product information (ePI) for selected human medicines harmonised across the European Union (EU).
The product information of a medicine includes its summary of product characteristics, labelling and package leaflet. These documents accompany every medicine authorised in the EU and explain how they should be prescribed and used. They can all be found, often as a PDF document, on the websites of EU regulators, with a printed package leaflet also provided in the medicine’s box. Digital platforms open 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 ePIs in real regulatory procedures is being explored through a one-year pilot initiative by HMA, EMA and the EC to enable the transition to the electronic system for medicines evaluated both nationally and at European level. The ePI initiative is an action under the Pharmaceutical Strategy for Europe supported by the EU funding programme EU4Health
The published ePIs are for medicines evaluated by EMA or by national authorities in Denmark, the Netherlands, Spain and Sweden. Companies participating in the pilot create and submit the ePI as part of their regulatory application. The pilot, which involves 25 medicines, will conclude in July 2024, and the outcomes will inform how to integrate the ePIs into common practice and expand their use across the EU.
The ePIs can be viewed at the Product Lifecycle Management Portal in English for centrally approved medicines and in the local language for nationally approved ones. Testing is ongoing to allow access to ePIs in all EU languages.
In addition, ePI data can be accessed via 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 EU ePI Common Standard adopted by the European medicines regulatory network to provide a consistent structure throughout all Member States and ensure the information works across different e-health platforms. This should facilitate the use of product information to meet individual needs and access requirements. Future developments could include functionalities such as automatic update notifications, access to supportive videos or audio content and online adverse-reaction reporting tools.