Overview
Leaphy provides a unified platform serving patients, healthcare providers, pharmacists, and pharmaceutical companies to manage electronic Product Information (ePI) leaflets across EU markets. The service includes a free patient app for barcode scanning, prescriber tools with drug classification and pricing data, pharmacy search functionality, and an API-driven platform for pharma companies to publish compliant leaflets.
Key people
In the news
- Your product information is approved. Now it needs to become an ePI. With ePI go-live for centrally authorised products starting with vaccines, many regulatory teams are asking the same question: how do we actually get our SmPC, Annex II, labelling and package leaflet into the EU ePI Common Standard? There are two routes. 🔹 Manual entry in EMA's PLM portal Copy the text, rebuild every table and upload every image, section by section, in the web editor. It works, but it is a large, repetitive and time-consuming job. And it has
- Another important step towards making electronic Product Information a reality in Europe. We’re pleased that Leaphy will be participating in the upcoming User Acceptance Testing (UAT) of electronic Product Information (ePI) organised by the European Medicines Agency. From 28 September to 9 October, participants will test the major functionalities for creating, managing and submitting multilingual ePI through the PLM Portal. For us at Leaphy, this is particularly relevant. We have been working on the practical side of ePI for some
- Milestone unlocked: Leaphy has successfully generated fully validated FHIR ePI files for all European languages. We're proud to share that our platform can now convert pharmaceutical product information into EMA-compliant electronic Product Information (ePI) — as structured FHIR R5 XML files — across every official EU language, with all files passing validation against the EMRN ePI Implementation Guide. This means SmPC, Annex II, Labelling and Package Leaflet content can now be transformed from source documents (Word/PDF) into
- Something big is changing in European medicine information. And we think more people should be talking about it. Electronic Product Information — ePI — is moving closer to real-world implementation. EMA has published its draft implementation roadmap. National competent authorities are preparing. Industry is running pilots across Europe. In fact, a recent overview from AESGP, EFPIA - European Federation of Pharmaceutical Industries and Associations and Medicines for Europe identified ePI pilot activity across 31 European
- Why now for ePI? Three things are lining up at once: Europe's move from paper leaflets to structured electronic product information is accelerating, the standards to do it properly (HL7 FHIR, ISO IDMP) are maturing, and pharma needs to manage leaflet data across every EU market. Leaphy sits exactly at that intersection — already live in Belgium, built on the standards, and expanding market by market. A standards-based platform for a market in its earliest stage. If you're building or backing the future of medicines information,
- Built on standards" isn't a slogan for us — it's the architecture. Leaphy is built on the EU Common Standard for ePI and the EMA's HL7 FHIR Implementation Guide, with metadata aligned to ISO IDMP and the Falsified Medicines Directive. That's what makes structured leaflet data portable, compliant, and ready for the systems pharma and healthcare already run. Standards are how digital health scales. We're all in. #FHIR #IDMP #ePI #interoperability #healthtech
- Managing leaflets across 27 markets shouldn't mean 27 processes. With Leaphy, you transform your leaflets into structured ePI once, then manage and publish across all EU markets from a single platform — metadata aligned with FMD and ISO IDMP, secured in Azure, delivered via app and API, with push updates to patients and prescribers. One source of leaflet truth. Every market, every language. Want to see it on your portfolio? Let's talk → leaphy.com/contact #regulatoryaffairs #IDMP #pharma #digitaltransformation
- Accelerate your transition to EMA-ready ePI. Move from legacy leaflets to EMA-ready ePI. Leaphy helps pharmaceutical organisations convert Word and PDF product information into structured, FHIR-compliant electronic Product Information with AI-supported conversion workflows, built-in quality control, and a path toward scalable ePI operations. Explore this service on the enw website: www.leaphy.com
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