From Leaflet to Living Data: What ePI Means for Pharmaceutical Translation in Europe

For decades, medicine information has been managed largely as a collection of documents: a Summary of Product Characteristics (SmPC) for healthcare professionals, a package leaflet for patients, and regulated text for labels and packaging.

That model is evolving. Europe is working towards electronic product information, or ePI: authorised medicine information prepared for electronic handling and distribution. The aim is practical: to make current information easier to find, read and use, whether the reader is checking a contraindication or how to take a medicine safely.

For pharmaceutical companies, ePI is not simply a new file format. It changes how approved information is structured, updated, translated and maintained through a product’s lifecycle. In a multilingual market such as Europe, language quality will be one foundation of its success.

What exactly is ePI?

EMA defines ePI as authorised statutory product information adapted for electronic handling and dissemination through websites, digital platforms and print. For human medicines, it includes the familiar components of regulated product information: the SmPC, the package leaflet and labelling; for centrally authorised products, the information package also includes Annex II.

the Summary of Product Characteristics (SmPC);
Annex II for centrally authorised products;
outer- and inner-packaging information; and
the package leaflet for patients and consumers.

What makes ePI different is its structure. It is not merely a PDF placed online. The EU ePI Common Standard is based on HL7 Fast Healthcare Interoperability Resources (FHIR), supporting consistent, machine-readable product information.

In practical terms, structured information can be more searchable, reusable and easier to connect with healthcare systems. A future patient-access model may, for example, use a code on a pack to reach current information in an available preferred language. These are implementation goals, not a statement that paper leaflets have already been replaced.

Where implementation stands

The transition is underway, but ePI is not yet universally mandatory across every EU procedure and market. EMA, the Heads of Medicines Agencies and the European Commission have developed a common approach over several years. A pilot involving centralised and national regulatory procedures ran from July 2023 to August 2024. It tested the creation and management of ePI through the Product Lifecycle Management (PLM) Portal and made selected ePIs publicly available through the portal and an API.

EMA published the March 2026 ePI roadmap as a draft. It proposes a phased rollout for centrally authorised products beginning around the end of 2026, initially on a voluntary basis. The proposed sequence starts with vaccines, then oncology products, before broader centrally authorised product coverage. English is planned as the initial implementation language, with multilingual implementation developing progressively. Nationally authorised products will require coordination with national competent authorities and national systems.

For companies, the sensible conclusion is neither to wait passively nor to assume that one date applies everywhere. Prepare content, terminology and internal processes while continuing to follow current EMA and national requirements for product information, QRD templates and linguistic review.

Why translation becomes more important

Europe’s pharmaceutical market has always depended on high-quality translation. ePI raises the stakes because translated text may be displayed through different systems, reused across channels and connected to other digital health information.

An unclear sentence in a leaflet is already a serious quality issue. In a structured environment, the same sentence may be distributed more widely and updated through connected outputs. Consistency, traceability and version control therefore matter alongside linguistic accuracy.

Pharmaceutical translators working with ePI must protect several layers at once:

Scientific meaning: indications, contraindications, dosage instructions, adverse reactions and warnings must remain medically precise.
Regulatory language: approved terminology, standard statements, headings and national conventions must be followed faithfully.
Patient understanding: patient-facing information must be clear and natural without altering approved meaning.
Digital structure: headings, lists, tables, identifiers, special characters and links between content elements must remain technically intact.

ePI localisation should not be treated as ordinary document translation followed by a quick formatting check. Linguistic review and technical validation are connected, but they are not the same task.

Practical multilingual challenges

One source must remain aligned with many languages

A change to a contraindication, storage condition or dosing instruction may affect the SmPC, package leaflet and labelling, as well as every approved language. Teams need to identify what changed, where the same information appears and which translations require revision.

Approved terminology must remain consistent

Product names, active substances, pharmaceutical forms, routes of administration and safety terminology should not vary between documents or updates. A validated termbase and well-maintained translation memory help, but both require human oversight. Previously translated content should not be reused simply because it looks similar.

Formatting carries meaning

In structured content, a heading is not merely larger text. Lists, tables, section levels and special characters can have a technical function. A translation may read well and still fail technical validation if the structure has been damaged.

Patient and professional language require different judgement

The SmPC serves healthcare professionals; the package leaflet communicates approved information to patients. Translators need the medical knowledge to preserve accuracy and the linguistic judgement to write appropriately for each audience.

Every update needs disciplined control

Product information changes throughout a medicine lifecycle. Safety variations, authority comments and company updates must be reflected correctly in affected languages. Without clear ownership and version control, even a small change can create inconsistencies.

How companies can prepare

Review approved source material

Confirm which versions of the SmPC, package leaflet and labelling are currently authorised. Resolve inconsistent product names, headings, phrases and formatting before structured conversion begins.

Build a product-specific terminology base

Record approved terminology for active substances, indications, dosage forms, adverse reactions and routes of administration, including terms that must remain untranslated and country-specific wording required by national authorities.

Assess existing translations carefully

Translation memories and earlier approved texts can provide a useful foundation. They should still be checked against the current source, current QRD templates and applicable local requirements. Legacy content often contains inconsistent wording accumulated through separate updates.

Match the workflow to the risk

Safety-critical content needs suitable life-sciences linguists, independent review where required and documented quality assurance. Numbers, units, frequencies, dosage instructions, negation, contraindications and storage conditions deserve specific checks.

Validate language and structure separately

A complete quality process should cover terminology, accuracy, completeness, numbers and readability, followed by technical validation of the structure and inspection of the final rendered content.

Prepare for ongoing change

ePI is designed for living product information. Companies should define who owns each stage, how approved changes are identified, how language versions are updated and how urgent safety information is handled.

CauLingo expertise

CauLingo supports multilingual workflows for pharmaceutical, clinical-research, medical-device and healthcare content through its Life Sciences translation services. The live service scope includes scientific, technical and patient-facing content, product information, terminology preparation, translation and localisation, revision and QA.

For organisations preparing content for ePI, CauLingo can support the language-workstream: terminology management, translation-memory preparation, multilingual translation, linguistic review, proofreading/editing, and linguistic QA of extracted or structured content. The appropriate workflow depends on the content, languages, technology environment and applicable regulatory process. CauLingo does not replace the responsibilities of the marketing authorisation holder, regulators or technical ePI implementation teams.

Medical translation services support healthcare and patient-facing communication, while CauLingo’s quality approach explains how terminology, revision and quality control can be combined according to project requirements. Where final document layout remains in scope, multilingual DTP publishing can support formatting and post-translation layout review.

Regional and language coverage

CauLingo’s Life Sciences service describes regional language capability across the Caucasus, Baltics, Balkans and Central Asia, alongside wider European multilingual workflows. For each project, CauLingo confirms the appropriate linguists and review process for the content, market and applicable requirements rather than assuming a uniform workflow for every language.

Frequently asked questions

Is ePI simply an electronic package leaflet?

No. The package leaflet is one part of ePI. The structured information can also include the SmPC and labelling and, for centrally authorised medicines, Annex II.

Will ePI replace printed leaflets?

Not automatically. EMA describes ePI as information adapted for digital channels and print. How electronic and printed information are used together will depend on legislation, implementation decisions and national requirements.

Can we use existing approved translations?

Often, at least in part. Existing translations, glossaries and translation memories are useful assets, but should be reviewed against the current authorised source, current templates and the required ePI structure before reuse.

Can machine translation be used?

Technology can support controlled workflows, particularly for content comparison and repetitive text. It should not replace qualified human review of safety-critical information. Confidentiality, terminology, numerical accuracy, regulatory wording and technical structure all need protection. See CauLingo’s approach to machine translation post-editing.

What is the difference between linguistic review and technical validation?

Linguistic review considers meaning, medical terminology, consistency, grammar, readability and regulatory wording. Technical validation confirms that structured content meets the required format and can be processed correctly. One cannot substitute for the other.

How should an urgent safety update be managed?

Work from one clearly identified approved source, map each affected section and language, prioritise translation by qualified specialists, complete the required independent review, verify terminology and numbers, and validate the final structure before release.

When should pharmaceutical companies begin preparing?

Now is the right time to assess content readiness. Cleaning source files, organising approved terminology and clarifying ownership can take longer than expected. Completing that work early can reduce rework as ePI becomes part of a product’s regulatory workflow.

Conclusion

ePI has the potential to make authorised medicine information more accessible, current and easier to use. Realising that potential will depend not only on platforms and technical standards, but also on the quality of the language presented to patients and healthcare professionals.

For pharmaceutical companies operating across Europe, translation is not simply the final step in ePI implementation. It is part of the content infrastructure. CauLingo can support the multilingual language workflow for product information as content and implementation requirements evolve.

Preparing pharmaceutical content for ePI? Contact CauLingo to discuss your content, languages and timeline.