EU ePI transition: converting PILs to electronic product information
Your PILs are in Word. The EU wants them in FHIR.
Article 66 of the agreed directive text requires the package leaflet in paper and electronic form, to standards the Commission will set by implementing act. EMA's own ePI programme, built on the FHIR-based EU ePI Common Standard, runs separately and is already moving towards go-live. Most teams don't yet know what they have, let alone how to convert it.
From a Word file to structured ePI
The leaflet content stays the same, but every section becomes a coded, machine-readable element that regulators, pharmacies and patients can query electronically.
Every leaflet, in every language
ePI covers the product information for every product, document type and EU language in your portfolio, not a single conversion.
3,600
Documents in an illustrative 50-product portfolio: SmPC, package leaflet and labelling in 24 languages (50 × 3 × 24)
24
Official EU languages. A product authorised across the EU needs product information in each Member State's official languages
5 years
From entry into force before the electronic leaflet requirement reaches products that are already authorised
From paper PIL to living ePI
This is more than a formatting update. It changes how product information is authored, stored, updated and delivered.
Format
Paper PIL in every pack. SmPC and PIL as Word or PDF. No structured data format required.
Package leaflet in paper and electronically (Art. 66(1)). Formats and standards set by Commission implementing acts. EMA's ePI uses the FHIR-based EU ePI Common Standard.
Storage & access
Documents in company systems with inconsistent versioning. No central EU repository for structured product information.
EMA must make a system for electronic product information available within 18 months of entry into force (Art. 66(7)).
Updating content
PIL changes require a variation and then reprinting. Outdated leaflets stay in packs until stock runs out.
Electronic versions can reflect an approved change immediately, while paper follows the next print run. Existing stock may be used up under the transitional rules.
Paper and patient access
Paper insert only. No digital access. Patients cannot search, translate, or adjust text size.
Member States may allow electronic-only leaflets for some or all products after consulting stakeholders. Patients keep the right to a free printed copy (Art. 66(3)).
The agreed text is not yet published in the Official Journal. Application dates will be fixed by the published act.
Get your product information ready for ePI
Workbench answers ePI questions against the agreed text and EMA's guidance, and reads your current leaflets. Alerts tracks EMA's roadmap and national decisions, and Print ProofReader checks printed leaflets against the approved text.
What's up next?We have 140 product information documents in Word. What does the new directive require for electronic leaflets, and how do we get to FHIR-structured ePI in time?
- understanding your question…
ePI transition · current rules against the agreed text
- Based on the agreed text, which is not yet in the Official Journal. Dates count from entry into force.
1. Short answer
The leaflet must be provided in paper and electronic form, to standards the Commission sets by implementing act. This applies to new applications 24 months after entry into force and to authorised products after five years.
2. What changes
3. What to do now
- Count your SmPCs, leaflets and labelling by product, market and language.
- Convert one product's leaflet to the EU ePI Common Standard as a pilot.
- Follow EMA's ePI roadmap for centralised products ahead of the directive dates.
Alerts
Watches EMA and the national authorities for ePI roadmap updates, submission guidance and decisions on electronic-only leaflets, and matches each one to the products it affects.
See AlertsPrint ProofReader
Compares printed leaflets and labelling against the approved text, so the paper leaflet that stays in the pack matches the approved wording after each change.
See Print ProofReaderWorkbench
Answers ePI questions against the agreed text and EMA's guidance, and reads your SmPCs and leaflets to say what moving them to the EU ePI Common Standard involves, with every point cited.
See WorkbenchA 30-minute live walkthrough of Atlas, Alerts and Workbench, on your own products and markets
EMA's ePI groundwork is already under way
EMA has piloted ePI and published its roadmap. The directive makes the electronic leaflet a legal requirement once it applies.
4
Member States in the EMA and national authority ePI pilot (Denmark, the Netherlands, Spain and Sweden), July 2023 to August 2024
EMA ePI pilot report, December 2024
18mo
For the Commission to adopt ePI standards and formats by implementing act, counted from entry into force
Art. 66(6), agreed directive text
6–12mo
Lead time we plan for when a packaging change needs artwork, validation and supplier sign-off, so packaging decisions can't wait for the final dates
Regunaut planning assumption
What teams are asking about ePI
What is ePI and when does it become mandatory?
Electronic product information is the authorised SmPC, package leaflet and labelling in a structured electronic format; EMA's version uses the FHIR-based EU ePI Common Standard. The agreed directive text provides for the electronic leaflet to apply to new MA applications 24 months after entry into force (once the implementing acts exist) and to products already authorised five years after entry into force. The calendar dates will be fixed by the published act. EMA's ePI go-live follows its own roadmap.
What is HL7 FHIR and why does it matter?
FHIR structures PIL content into machine-readable, tagged sections rather than free text in Word. This makes information searchable, translatable and interoperable with hospital and pharmacy systems.
How many documents do I need to convert?
A 50-product portfolio with three document types in up to 24 languages already means several thousand documents, before national variants.
What happens to the paper PIL?
The agreed text keeps the paper leaflet in the pack alongside the electronic version. Member States may decide, after consulting patients and healthcare professionals, to require only the electronic version for some or all products, with a free printed copy on request.
How does ePI interact with variation management?
Every approved variation affecting PIL content requires an ePI update. Without linking variation tracking to ePI records, digital product information falls out of sync with the approved MA.
Related reading
- To plan conversion, QRD alignment and approvals, see labelling review and ePI planning.
- Converted text can be checked line by line against the approved source with automated artwork proofreading.
- For a short definition, read the glossary entry on electronic product information (ePI).
- ePI is one of ten changes covered in our guide to the new EU pharmaceutical directive.
- Dates that depend on publication are tracked on the EU pharma package legislative timeline.
Sources
Article numbers refer to the Council's position at first reading of 28 September 2026 (ST 7106/2/26 REV 2 for the directive, ST 7105/2/26 REV 2 for the regulation), which reflects the political agreement of December 2025. Numbering may change in the act published in the Official Journal.
- European Medicines Agency: Electronic product information (ePI)
- Council of the EU: Directive on the Union code relating to medicinal products for human use, Council position at first reading, 28 September 2026 (ST 7106/2/26 REV 2), Articles 66 and 221
- European Medicines Agency: EMA welcomes political agreement on new EU pharmaceutical legislation (December 2025)
- EUR-Lex: Directive 2001/83/EC on the Community code relating to medicinal products for human use (current labelling and package leaflet rules)
- Council of the EU: 'Pharma package': Council and Parliament reach a deal (press release, 11 December 2025)
- Council of the EU: The pharma package, new EU rules on medicines (policy page)
- European Commission: Reform of the EU pharmaceutical legislation
- EUR-Lex: Procedure 2023/0132/COD, Directive on the Union code relating to medicinal products for human use (COM(2023) 192)
- EUR-Lex: Procedure 2023/0131/COD, Regulation on Union procedures for the authorisation and supervision of medicinal products (COM(2023) 193)
Know where your product information stands before ePI applies
The electronic leaflet reaches products already authorised five years after entry into force, and EMA's own ePI programme is already moving. Start with the products and languages that need the most conversion work.
Book an ePI walkthrough
30 minutes on your own portfolio: what the electronic leaflet rules mean for your product information, and where Alerts, Print ProofReader and Workbench fit.
Book a demoAsk Workbench yourself
Put your ePI questions to Workbench and get answers that cite the agreed text and EMA's ePI guidance.
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