Table of Contents
2 - What are the Key Principles for ePI?
3 - What is the EU ePI Common Standard?
4 - How long does it take to create an ePI?
5 - How and when will ePI be implemented across EU Member States?
7 - How does ePI interact with SPOR and PMS?
8 - How will legacy product information be handled in the context of ePI?
9 - What is the objective of introducing ePI in the EU?
10 - How does ePI benefit patients and healthcare professionals?
11 - Is ePI legally binding product information?
12 - What are the prerequisites for creating an ePI?
13 - Will aligning PMS data (e.g. Module 3 composition) affect ePI?
14 - Can MAHs author and maintain ePI directly in the PLM portal, and are headings editable?
15 - Will track changes be available in the ePI editor?
16 - MAHs use external systems to create ePI and upload it to the PLM portal?
17 - When is ePI submitted during a variation, and must it be provided in FHIR?
18 - Will procedure numbers be included in the ePI?
19 - Will completion or submission of ePI become mandatory, and when?
20 - What language requirements apply to ePI?
21 - How are translations handled, and can multiple languages be managed at once?
22 - Will bulk upload functionality be available?
23 - How can an ePI be printed?
24 - Will QRD template changes be reflected in the FHIR Implementation Guide?
Acronym key and glossary terms
Questions and answers
1 - What is ePI?
Electronic product information (ePI) refers to the authorised, statutory product information for medicines (including the summary of product characteristics, package leaflet and labelling) created using the EU ePI Common Standard. ePI is adapted for handling in electronic format and dissemination via the web, e-platforms and in print. In certain procedures, Annex II of the marketing authorisation (manufacturer(s) responsible for batch release, conditions and requirements of the marketing authorisation, other conditions or restrictions as applicable) is provided electronically in the ePI.
2 - What are the Key Principles for ePI?
In 2020, EMA, the Heads of Medicines Agencies (HMA) and European Commission published key principles to guide the development and use of ePI for human medicines in the EU.
They outline how ePI:
Benefits public health
Creates efficiency gains for regulatory systems
Aligns with the existing legislative framework
Fits into the EU’s multilingual environment
Interacts with other ongoing digital initiatives at EU and global level
3 - What is the EU ePI Common Standard?
The EU ePI Common Standard is a standard developed and adopted by the EU Network Data Board on behalf of the European Medicines Regulatory Network. It can enable user-friendly, multilingual ePI linked to SPOR master data system.
4 - How long does it take to create an ePI?
The time needed to create an ePI using the editor in the PLM portal was measured during the ePI pilot. During the pilot, the average time taken to create a new ePI was 5.2 hours. Since it can be assumed that the majority of the effort of ePI creation is for the first-time creation of the ePI, and updating ePI in subsequent variations is expected to be less laborious, the effort required in the pilot is considered acceptable.
5 - How and when will ePI be implemented across EU Member States?
According to the ePI roadmap, implementation will follow a phased approach. Member States will adopt ePI based on their national priorities, readiness and available resources, meaning some may start earlier than others. EMA, the ePI team and the EU network will support a managed, orderly and harmonised rollout across the EU, ensuring consistent application of the EU ePI Common Standard.
6 - Which medicines are currently in scope for ePI, and does it also cover veterinary medicinal products?
The current scope of ePI covers human medicines authorised in the EU and EEA, starting with centrally authorised products and progressively including nationally authorised medicines depending on national implementation priorities. While the EU ePI Common Standard is designed for human medicines, it can also be applied in the future to the product information of veterinary medicinal products.
7 - How does ePI interact with SPOR and PMS?
ePI is linked to products in PMS, which enables leveraging of both ePI and PMS data for a product. SPOR supplies some master data used in ePI, including information on marketing authorisation holders and competent authorities through OMS. The use of SPOR data within ePI will continue to grow as the system further develops.
8 - How will legacy product information be handled in the context of ePI?
ePI can be created by the applicant in the context of a marketing authorisation application (for new medicines) or a post-authorisation procedure that affects the product information (for medicines already on the market). The rollout to ePI for legacy medicines is expected to happen in stages, during a transition period, allowing sufficient time to applicants to adopt ePI across their portfolios.
9 - What is the objective of introducing ePI in the EU?
The objective of ePI is to improve access to up-to-date medicinal product information for patients and healthcare professionals, while supporting regulatory efficiency through structured, interoperable and reusable product information data. ePI supports the digital transformation of the European Medicines Regulatory Network.
10 - How does ePI benefit patients and healthcare professionals?
ePI improves accessibility, usability and availability of authorised product information by enabling digital access through websites and other electronic platforms. Structured ePI also supports improved searchability, accessibility tools, and the potential for integration with digital health systems.
11 - Is ePI legally binding product information?
Yes. ePI represents the authorised product information in electronic format. The content of ePI reflects the approved Summary of Product Characteristics (SmPC), Package Leaflet (PL) and labelling as part of the marketing authorisation.
12 - What are the prerequisites for creating an ePI?
To create an ePI, a user must have an ePI role and be logged into the PLM portal (ePI Applicant roles and permissions are explained in the ePI registration guide). An ePI is created at the PLM portal using the editor or via FHIR import. Once created, the applicant selects the appropriate product from PMS to link to the ePI, ensuring that the electronic document is associated with the correct authorised product entry.
13 - Will aligning PMS data (e.g. Module 3 composition) affect ePI?
No impact is expected. Module 3 contains quality‑related information on the product’s composition, and reflecting this information consistently in PMS helps maintain accurate product master data. This does not affect how ePI is created or maintained.
14 - Can MAHs author and maintain ePI directly in the PLM portal, and are headings editable?
Yes. The ePI editor allows MAHs to draft and maintain product information, and headings may be updated where appropriate.
15 - Will track changes be available in the ePI editor?
Not at present. “Track changes” is not currently planned. It may be considered as a future enhancement. Users can rely on their usual document workflows and then create or import the final agreed text in ePI.
16 – Can MAHs use external systems to create ePI and upload it to the PLM portal?
Yes. MAHs may create FHIR ePI using external tools and upload it one language at a time. FHIR is the structured format used for EU ePI. EMA does not provide a Word‑to‑FHIR plugin and does not publish or endorse vendor lists.
17 - When is ePI submitted during a variation, and must it be provided in FHIR?
ePI is submitted before the beginning and/or the end of the procedure, after the final text has been agreed. Details will be provided in the procedural guidance to be published shortly. ePI may be produced in the editor or uploaded as a FHIR ePI. This submission is in addition to the Word/PDF product information required in eCTD, which remains the basis for regulatory assessment.
18 - Will procedure numbers be included in the ePI?
Yes. Procedure numbers identify which regulatory activities resulted in updates to the product information and help distinguish published and archived versions of the ePI.
19 - Will completion or submission of ePI become mandatory, and when?
Timelines for mandatory ePI submission are according to the upcoming, revised EU Pharmaceutical Legislation.
20 - What language requirements apply to ePI?
There are no new language requirements for ePI. The same languages required for the Word and PDF product information are to be submitted for ePI also.
21 - How are translations handled, and can multiple languages be managed at once?
Translations may be drafted in the editor or imported as FHIR files. At present, language versions must be imported one at a time, and translations cannot be generated automatically in the portal. Support for multi‑language import may be considered in future development.
22 - Will bulk upload functionality be available?
Yes in future. A stepwise development approach is planned to support uploading multiple FHIR files.
23 - How can an ePI be printed?
Use the “Export to Word” option at the PLM portal and print the exported file. The exported document, derived from the ePI, is for offline or paper use where appropriate. The exported Word file can also be used for submission of Word files to the regulator and for quality control purposes.
24 - Will QRD template changes be reflected in the FHIR Implementation Guide?
Yes. Updates to the QRD template will be reflected in future versions of the FHIR Implementation Guide so that the structure of ePI remains aligned with the approved QRD format.