For as long as EU medicines have been regulated, the summary of product characteristics and package leaflet have been Word documents that become PDFs that become printed paper. That model is being replaced. In March 2026 the European Medicines Agency and the regulatory network published a draft roadmap for electronic product information, setting out a phased, therapeutic-area-by-therapeutic-area go-live that begins with centrally authorised products and eventually reaches every medicine in the EU.
What ePI actually is
Electronic product information is the authorised, statutory product information — SmPC, package leaflet and labelling — held in a structured electronic format rather than as a flat document. It is built on the EU ePI Common Standard, which is based on HL7 FHIR, the same interoperability standard used across electronic health records.
The practical significance is that product information becomes data. It can be searched, filtered, delivered in multiple languages, updated centrally and consumed directly by hospital and pharmacy systems. It is not simply a PDF on a website.
The roadmap: voluntary first, mandatory later
EMA and a group of national competent authorities — including Denmark, the Netherlands, Spain and Sweden — tested ePI creation during live regulatory procedures in a pilot that ran from July 2023 to August 2024. The draft roadmap published in March 2026 builds on that experience. Its key features:
- Phased voluntary go-live for centrally authorised products from Q4 2026, beginning with vaccines (ATC code J07), followed by oncology products (ATC codes L01 and L04), then progressively wider therapeutic areas.
- Authoring or uploading via the PLM Portal, as an additional step alongside the existing Word and PDF submission — not, initially, as a replacement for it.
- English first. Initial implementation covers English, with all other languages optional; full multilingual delivery comes at a later stage.
- Once electronic, always electronic. When a product’s information is available in ePI format, it stays in that format through all subsequent variations.
- Nationally authorised products follow. A survey and readiness assessment of national competent authorities is planned, with national implementation timelines to be confirmed in a final roadmap.
Under the current legislation, ePI is not a legal obligation, which is why this phase is voluntary. That changes with the new EU pharmaceutical legislation, whose compromise texts were published in March 2026. Companies should read the voluntary window as a preparation period rather than an optional extra.
What it changes operationally
The shift is less about technology than about how regulatory content is managed. Structured product information exposes inconsistencies that PDFs conceal: divergence between national translations, versions that no longer match the approved text, and local artwork that has drifted from the authorised leaflet. Companies whose product information lives in scattered documents rather than a controlled content system will feel this first.
There is also a separate strand on patient access. EMA consulted in 2025 on a reflection paper proposing that patients reach a medicine’s ePI by scanning a two-dimensional code on the pack — a change that would touch artwork, serialisation and labelling processes as well as regulatory content.
What this means in Greece
Most medicines on the Greek market are nationally authorised or approved through mutual recognition and decentralised procedures, so the national implementation phase matters more here than the centralised one. Greek-language delivery also depends on the multilingual stage of the programme rather than the first release. The sensible position for companies operating in Greece is to prepare content and processes now, while tracking how EOF and the wider network sequence national roll-out.
How PQRA helps
PQRA supports marketing authorisation holders in getting product information ready for a structured future: reviewing SmPCs, leaflets and labelling for consistency across procedures and languages, aligning variation and lifecycle processes with the PLM Portal workflow, assessing where ePI adoption would be low-risk for a given portfolio, and monitoring EU and Greek implementation so that deadlines are anticipated rather than met in a rush.
The voluntary phase is the cheapest time to find the problems in your product information. Speak to PQRA about preparing your portfolio for ePI.
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