This article is for information only and reflects is based on questions frequently asked during the Quarterly System Demos up to and including the Q4 2025 session held on 16 December 2025, as well as from other ePI engagement activities. Nothing in this article should be taken as an explicit commitment on behalf of the EMA, or the ePI product teams.
For convenience, many technical terms are explained in the table of abbreviations at the beginning of this article.
For general inquiries, please contact the ePI team via ePI@ema.europa.eu. For questions or comments around the content of this article, please raise a ticket via the EMA Service Desk.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Will completion or submission of ePI become mandatory, and when?
Timelines for mandatory ePI submission are according to the upcoming, revised EU Pharmaceutical Legislation.
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.
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.
Will bulk upload functionality be available?
Yes in future. A stepwise development approach is planned to support uploading multiple FHIR files.
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.
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.
Known issues in ePI
Here you can find the issues in the PLM Portal - ePI that the ePI team is aware of and details of workarounds where available. Should you encounter one of the issues below, it is not necessary to open a Service Desk ticket, as the team is already working on these issues. If your issue is not listed, please open a Service Desk ticket.
Issue Name
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Incorrect formatting of pasted bulleted lists
When bulleted lists are pasted into the editor, the bullet type changes and/or the bulleted text is not correctly justified
Copy and paste bulleted list into the editor window using CtrlC-CtrlV.
Bulleted list appears in the editor window with the exact same formatting as in Word.
Bullet type changes and/or the second and following lines of the bullet text are not correctly justified to the first line.
Paste the list as unformatted text. Then, in the editor, click on 'Bullet list' at the top of the editor window. The bullet type may not be identical to the QRD template, this will be tolerated for ePI.
ePI will only allow bullet types supported by html, namely disc, circle and square. Any of these three bullet types can be used in ePI.
Incorrect justification of bullet text is a current limitation of the text editor.
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Short underline appearing in blank line
In pasted text, short underlines, that were not present in the original text, appear in otherwise empty lines. While these lines appear empty in the source Word document, in fact they are formatted as underline + italic or as underline + bold.
Copy and paste text into the editor window using CtrlC-CtrlV.
Text appears in the editor window with the exact same formatting as in Word.
A short underline appears in an otherwise blank line.
This issue can be overcome in 2 ways: 1. In the empty line in the Word document, remove the underline, bold or italic styling, alternatively 2. in the editor window, manually remove the unwanted underline.
Including underline on blank lines is a current limitation of the text editor.
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Line spacing too wide in pasted text
In pasted text with single line spacing, line spacing in some paragraphs of the text appears wider in the editor.
Copy and paste paragraphs of text into the editor window using CtrlC-CtrlV.
Text appears in the editor window with the exact same line spacing as in Word.
In some cases, paragraphs appear to have wider line spacing and are not consistent with surrounding paragraphs.
Prior to pasting the text, ensure all paragraphs in Word have the same Style associated with them.
As this issue relates to the styling of the Word document, it will need to be resolved in Word prior to pasting. The ePI team will report here in case this changes.
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Subscript and superscript create uneven line spacing
In pasted text with subscript and/or superscript the line spacing is uneven in the editor.
Copy and paste text containing subscripts/superscripts into the editor window using CtrlC-CtrlV.
Text appears in the editor window with the exact same line spacing as in Word.
Line spacing is uneven to accommodate subscript/superscript.
Uneven line spacing is tolerated in ePI.
The ePI team will work on this issue in future improvements to the editor.
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Sub-sections can only be re-ordered in the editor and not directly in FHIR
Blank sub-sections can be added in documents to include sub-sections that are not in the QRD template. These sub-sections can only be re-ordered manually, using the editor of the ePI portal. If a user implements a new order of sub-sections directly in FHIR (so outside the ePI portal), the new order is not kept after the FHIR is uploaded in the ePI portal.
At the "Manage ePI" page, select the language you wish to import and click on "Upload FHIR". From your local area, select a FHIR file whose sub-sections have been previously reordered in a FHIR/xml editor and click "OK".
The order of the blank sub-sections in the portal is updated to reflect the order of the imported FHIR file.
The blank sub-sections have not been re-ordered as desired.
User can re-order blank sub-sections manually, using the editor of the ePI portal (click on the ellipsis to the right of the sub-section name, and select "Move up"/"Move down".
The ePI team will work on this issue in future improvements to the Upload FHIR functionality.
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Title pages of exported Word documents are not in the correct language.
In the exported Word document, the names of product information documents on the title pages (e.g. Summary of Product Characteristics, Labelling, Package Leaflet) appear in English and not in the expected language.
At the "Manage ePI" page, select the language you wish to export and click on "Export". In the "Export" window, select the format "Word (all ePI documents in one file with title pages)". Then click "Export".
The document names on the title pages: "Summary of Product Characteristics", "Annex II" "Labelling", "Package Leaflet" are in the language of the template in the exported Word document.
The names of the documents are in English.
Manually change the names of the product information documents in the exported Word documents.
The ePI team will work on this issue in future improvements.
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Reordering blank sub-sections will affect the order of non-mandatory sub-sections later on
It is currently possible to add blank sub-sections in order to include sub-sections that are not in the QRD template. Once added, these sub-sections can then be reordered in the editor. If a user moves up a blank sub-section and then within the same parent section inserts one or several non-mandatory sub-sections, the latter are not inserted in the correct order in the tree view (as per the order in the QRD template).
In the editor, navigate to a parent section where several non-mandatory sections can be added according to QRD rules (e.g. section 4.6 of the SmPC or section 2 of the package leaflet).
Click on the ellipsis menu to the right of the parent section name. Add both a blank sub-section and a non-mandatory (pre-defined) sub-section.
Click on the ellipsis menu to the right of the blank sub-section name and select "Move up" once or several times. Add the remaining available non-mandatory sub-sections.
The order of the non-mandatory sub-sections in the editor is as per the QRD template.
The non-mandatory sub-sections are in a different order than in the QRD template. If the user removes and adds the non-mandatory sub-sections again, they will still be listed in the wrong order. The ellipsis menu will also display them in the wrong order afterwards.
User should first add the non-mandatory sub-sections. If additional blank sub-sections are needed, they should be added afterwards.
The ePI team will work on this issue in future improvements.
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ePI editing and publishing not possible for Irish national products (NAPs) and MRP/DCP products with Ireland as Concerned Member State (CMS).
Applicants are not able to access the editor of ePIs for Irish national products (NAPs) and for Mutual Recognition/Decentralised (MRP/DCP) products where Ireland is a Concerned Member State (CMS).
In addition, the Irish medicines regulator is not able to publish these ePIs.
Accessing the editor for NAPs(only for applicants):
On the “Create New ePI” page, select the following options: “Domain: Human”, “Authorisation type: NAP”, “Medicines Reg. Agency: Ireland”. Type the name of the medicine and select the relevant marketing authorisation holder. Click on “Save and Next”.
At the “Add Co-author” page, click on Next.
At “Manage ePI” page, select EN, then click on ”Go to Editor”.
Accessing the editor for MRP/DCP products(only for applicants)
On the “Create New ePI” page, select the following options: “Domain: Human”, “Authorisation type: MRP/DCP”,“Medicines Reg. Agency: Ireland”. Answer “No” to the question “Is this the reference member state?”. Type the name of the medicine and select the relevant marketing authorisation holder. Click on “Save and Next”.
At the “Add Co-author” page, click on "Next".
At “Manage ePI” page, select EN, then click on ”Go to Editor”.
Publishing the Irish NAPs and MRP/DCP products with Ireland as CMS (only for Irish medicines agency users):
On the “ePI list” page, navigate to the Submission tab, locate an ePI that is either an Irish NAP or an MRP/DCP product with Ireland as CMS. Ensure it has been approved. Approved ePI are marked with a green bar to the left of their EPI ID. Click on the Action dropdown menu on the right-hand side. Select 'Publish'.
The applicant sees the editor with its tree navigation menu and is able to insert text.
The regulator sees a pop-up window to confirm that the user wants to publish the selected ePI. Once published, the ePI is publicly available.
The applicant sees a spinning wheel and an error message in the background. The editor is not accessible.
The regulator sees a red modal with an error message. The ePI is not published.
There is no workaround at the moment.
The ePI team is working to resolve the issue.
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Export to FHIR not working - RESOLVED
It is not possible to export to FHIR from the "Manage ePI" page.
At the "Manage ePI" page, select the language you wish to export and click on "Export". In the "Export" window, select to export in FHIR format. Click "Export".
The ePI is exported to your local downloads folder.
User sees an error message and no FHIR file is downloaded.
It is possible to export to FHIR the ePIs available on the "Published ePIs" page. There is no workaround to export to FHIR the ePIs that are not published.
The ePI team is working to resolve the issue.
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Irrelevant organisations listed in the "Medicines Regulatory Agency" lookup on "Create New" page
When creating an ePI for a nationally-authorised medicine (NAP) or for a medicine authorised via the decentralised (DCP) or mutual recognition procedures (MRP), user has to indicate the national competent authority to whom the ePI will be submitted. The authority that the user selects can only be one of the human medicines regulatory agencies listed on the EMA website.
At the moment, in addition to the correct medicines regulatory agencies, the “Medicines Regulatory Agency” lookup also displays regulatory agencies that are not responsible for medicines regulation.
At the "Create new" page, start creating a new ePI for a human NAP or MRP/DCP medicine.
Open the lookup for Medicines Regulatory Agency and in the "Search" inbox type one of the following countries: Austria, France, Spain, Bulgaria, or Germany.
Press ENTER.
The "Medicines Regulatory Agency" lookup displays the relevant medicines agency/agencies in the indicated country.
After selecting the medicine agency, the user navigates to the "Manage ePI" page and sees the relevant QRD templates loading (i.e. in the correct language(s)).
The “Medicines Regulatory Agency” lookup also displays regulatory agencies that are not responsible for medicines regulation.
In addition, if the user selects one of such agencies, no templates are loaded on the “Manage ePI” page.
User has to make sure that the correct medicines regulatory agency (as per the EMA website)is selected inthe “Medicines Regulatory Agency” lookup when the ePI is created. There is no workaround to change the medicines regulatory agency for an ePI once the ePI has been created.
The ePI team is working to resolve the issue.
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The character “&” is not escaped in the exported FHIR xml when “&” is included in the heading of a section
There are cases when “&” has to be included in the heading of sections: e.g. when “&” is part of the name of the medicine and therefore appears in the heading of several sections (such as 1, 2, 3, 5) of the package leaflet. In such cases, the “&” character is not escaped in the exported FHIR xml.
In the editor, add “&” in the heading of a section of the SmPC or package leaflet. Click "Save" and "Exit Editor".
At the "Manage ePI" page, select the language recently edited and click on "Export".
In the "Export" window, select to export in FHIR format. Click "Export".
Open the exported FHIR xml file with an xml editor and locate the section heading where “&” has been introduced.
The “&” in the heading has been escaped to & or &.
The “&” in the heading has not been escaped and appears as such.
In addition, if the user tries to import the same FHIR file back in the ePI portal, the Validation/Import fails.
The user can manually replace the “&” with either & or & directly in the FHIR file.
