For as long as most pharmaceutical labeling teams have worked in the industry, product information — the Summary of Product Characteristics, the Package Leaflet, the labeling text — has existed as static content: authored in Word, submitted as PDF, printed, and occasionally updated through a formal variation process. That is changing, and the timeline for the change is no longer theoretical.
In March 2026, the European Medicines Agency published a draft roadmap for the phased implementation of electronic Product Information (ePI) — moving product information from static documents to structured, machine-readable data built on the FHIR standard. This guide covers what ePI actually is, where the EMA roadmap currently stands, what "dual-channel" obligations mean for teams managing both a print and an electronic version, and what the content migration effort looks like in practice.
Scope note: this guide reflects the EMA draft roadmap as published in March 2026. The roadmap is explicitly a draft, and implementation dates may shift as the network's quarterly system demos and pilot feedback continue. Verify current status against the EMA ePI page before acting on specific dates.
What ePI Actually Is
Electronic Product Information refers to the same statutory content that has always accompanied a medicine — the SmPC, the Package Leaflet, and the labeling — adapted for structured, electronic handling rather than static PDF. The EU ePI Common Standard is based on Fast Healthcare Interoperability Resources (FHIR), the same international technical standard used across electronic health record systems, giving product information a machine-readable structure rather than a page-based document format.
The practical difference this creates: content authored once, in structured form, can be published, updated, and disseminated across multiple channels — the European Medicines Web Portal, national competent authority websites, healthcare provider systems, and eventually patient-facing digital tools — without re-authoring the content separately for each destination. A correction made to the approved source updates everywhere it's referenced, rather than requiring a new PDF to be generated and redistributed to every channel individually.
This is not a new legal category of information. It is the same regulated content, delivered through a different technical mechanism — which is precisely why the transition is as much an operational and content-management challenge as a regulatory one.
Where the EMA Roadmap Currently Stands
EMA and the European medicines regulatory network published a draft implementation roadmap for ePI on March 20, 2026, following a one-year pilot project (July 2023 to August 2024) conducted with national competent authorities in Denmark, the Netherlands, Spain, and Sweden.
Per the roadmap and subsequent industry reporting, implementation is phased by therapeutic area rather than applying to all products simultaneously. Vaccines are positioned for voluntary go-live first, with oncology products following shortly after, and other Centrally Authorised Products (CAPs) progressing to voluntary ePI submission afterward. All timelines in the roadmap are described as targets for an orderly, phased rollout rather than a single cutover date — and the roadmap explicitly ties full mandatory implementation to the entry into application of the EU's revised pharmaceutical legislation, which has its own separate timeline still working through the EU legislative process.
Two details from the draft roadmap are worth planning around now, regardless of exactly when each therapeutic area's window lands:
Initial implementation is English-only. Full multilingual ePI delivery is described as a later-stage capability, not part of the initial go-live for any therapeutic area. Teams should not assume multilingual ePI arrives at the same time as English-language ePI for their products.
Once electronic, a product's information stays electronic. The roadmap indicates that once a product's information has been submitted in ePI format, all subsequent variations for that product continue in electronic format going forward — meaning the decision to move a product's product information to ePI is not easily reversible on a variation-by-variation basis.
Authoring will happen through EMA's Product Lifecycle Management Portal, as an additional step alongside — not instead of — the current Word/PDF submission process during the transition period. This dual-submission requirement is itself an operational burden worth planning for: teams will maintain two authoring workflows in parallel for a period, not a single replaced one.
What "Dual-Channel" Actually Requires
The term "dual-channel" refers to the practical reality that ePI does not eliminate the requirement for a physical package leaflet. Article 58 of Directive 2001/83/EC requires that a package leaflet be included in the packaging of all medicinal products, unless all required information is conveyed directly on the packaging itself — and nothing in the ePI initiative removes this obligation. EMA's own guidance is explicit that electronic delivery mechanisms such as QR codes or other mobile technologies can provide additional access to information, but cannot replace the statutory printed leaflet.
This means that for the foreseeable future, pharmaceutical labeling teams are not transitioning from print to electronic — they are managing both simultaneously, and keeping them synchronized. A correction to the approved product information needs to be reflected accurately and promptly in both the printed leaflet and the electronic version, regardless of which channel was updated first in a given workflow.
Package linking is part of the architecture, not an afterthought. EMA ran a public consultation (closed June 2025) on a reflection paper exploring how patients access ePI from the physical pack — principally through 2D/QR codes, with NFC also explored as a linking mechanism. Where a package carries a code linking to electronic product information, that link needs to resolve to content that matches the current approved version — which means the physical pack, the code it carries, and the electronic content it points to all need to stay in sync through every subsequent revision.
The synchronization risk is a verification problem, not just a technical one. A revision to the approved SmPC needs to propagate accurately to: the printed PIL, the electronic ePI content, and (where applicable) any pack-level code or reference pointing to that content. Where these are maintained through separate authoring processes — a Word/PDF workflow for print, a structured FHIR workflow for ePI — the risk is the same unpropagated-change failure that affects any multi-version labeling process, just with an additional format and channel added to the equation.
What the Content Migration Effort Actually Involves
For pharmaceutical companies with an established product portfolio, moving to ePI is not simply a matter of submitting future content differently — it involves migrating existing product information into structured format, and doing so without introducing errors, losing regulatory history, or disrupting ongoing maintenance obligations.
FHIR compatibility is a data structure question, not a formatting one. Product information currently maintained in Word documents and PDFs is unstructured or semi-structured text. Structured FHIR-based content requires the same information to be organized into discrete, machine-readable data elements. This is a genuine content restructuring exercise, not a file conversion — and the quality of that restructuring determines whether the resulting ePI accurately reflects the approved content or introduces subtle discrepancies during the migration itself.
Character-level fidelity matters most during migration, not after. The highest-risk point in the ePI transition is the initial migration of existing approved content into structured format — this is where a transcription error, a dropped qualifier, or a misaligned data field is most likely to enter, precisely because the content is being handled through an unfamiliar process for the first time. Verifying the migrated structured content against the approved source PDF or Word document, at the character level, is the specific check that catches migration errors before they propagate into a live ePI submission.
Realistic timelines run longer than most portfolio-level planning assumes. For a mid-sized pharmaceutical company managing a portfolio of 50 or more products across multiple EU markets, a realistic preparation timeline — covering FHIR workflow adoption, content migration, validation of any new authoring or comparison tooling, and staff readiness — runs to 18 to 24 months rather than a single-quarter project. Given that ePI tooling used in a GxP-regulated submission process is itself subject to 21 CFR Part 11 and EU Annex 11 validation requirements, that validation work needs to be planned into the timeline from the outset, not added after tooling is already in use.
What Labeling Teams Should Be Doing Now
Given a roadmap that is still in draft form but moving, with concrete near-term phases already identified, the practical planning steps are:
Audit current product information workflows for FHIR readiness. Identify which products and content are currently authored in Word/PDF and assess what structural changes would be needed to represent that same content in FHIR format.
Treat dual-channel synchronization as a defined verification step, not an assumption. Wherever both a printed leaflet and an ePI submission exist for the same product, establish an explicit comparison step confirming both versions reflect the same approved content — rather than assuming two separately maintained workflows will stay aligned without a check.
Plan validation into the ePI tooling timeline from the start. Any new authoring or comparison tool introduced to support ePI workflows needs GxP validation before it's relied on for submission-supporting decisions. Building this into the 18–24 month planning window avoids a late-stage scramble.
Watch the therapeutic area sequencing relevant to your portfolio. Since the rollout is phased by therapeutic area rather than universal, teams with vaccine or oncology products in their portfolio have a shorter runway than teams without products in those categories — worth confirming where your specific products sit in the sequence as EMA's quarterly system demos provide updates.
The shift to ePI does not remove the verification requirement that has always applied to pharmaceutical labeling — it adds a format and a channel to what needs to be verified. A migration error introduced into structured content, or a dual-channel synchronization gap between print and electronic versions, is the same category of failure as any other unpropagated label change: invisible to a review that checks only one version, and reliably caught only by comparing every version against the approved master.
Further reading
- EMA — Electronic product information (ePI) overview page
- EMA — ePI draft roadmap (PDF, published 20 March 2026)
- Directive 2001/83/EC, Article 58 — package leaflet requirement (EUR-Lex)
- EMA — Product Lifecycle Management Portal
- EMA — draft reflection paper on package linking to ePI (consultation closed June 2025)
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