December 12, 2025

ePI Is Here: How ForgeStop's Smart Label Platform Delivers Compliant Digital Medicine Information at Scale

Electronic Product Information (ePI) is reshaping pharma compliance. Discover how ForgeStop delivers real-time, multilingual, audit-ready ePI at global scale.

The pharmaceutical industry is undergoing a critical shift. Electronic Product Information (ePI) has moved from pilot phase to active implementation—and the question is no longer if but how pharmaceutical brands will deliver compliant, localized, real-time product information at scale.

Driven by the EMA, HMA, and European Commission, ePI is reshaping how patients and healthcare providers access essential medicine information. The EMA's ePI pilot wrapped in August 2024 with 23 ePIs successfully produced. In January 2025, the pilot report recommended phased voluntary rollout for centrally authorized products. Pharma is investing heavily in smart packaging, QR codes, GS1 2D barcodes, and NFC smart labels to connect each pack to digital services. The regulatory runway is clear.

The infrastructure question remains: Who manages all that dynamic, regulatory-grade content behind every code—at batch, sub-batch, and unit level?

This is exactly what ForgeStop has already built with our Smart Label platform. While many of our pharma partners use NFC for authentication, the same engine is also ideal for ePI content management and delivery.

What Is ePI?

Electronic Product Information (ePI) refers to the digital version of authorized medicine documents:

  • SmPC (Summary of Product Characteristics)
  • PIL (Patient Information Leaflet)
  • Labelling data

Unlike folded paper inserts, ePI is structured, multilingual, and instantly updatable—accessible via QR codes, GS1 DataMatrix, or NFC smart labels printed on packaging.

👉 Related: How NFC and RFID Are Transforming Asset Tokenization"NFC transforms packaging into intelligent gateways—enabling asset tracking from factory floor to patient hand. The same tech now powers ePI's tap-to-access experience."

Why the Shift to ePI Is Accelerating

This isn't just a digitization trend—it's a regulatory evolution with measurable benefits:

  • Real-time safety updates minimize patient risk
  • Language localization improves accessibility across regions
  • Digital delivery supports EU sustainability goals
  • Structured data formats (FHIR) enable healthcare system integration

ePI also aligns with broader European digital regulations—including Digital Product Passports (DPP), mandatory by 2027. For pharma brands, ePI is the dress rehearsal.

👉 Related: Digital Product Passports (DPP): What They Are and How ForgeStop Helps Brands Prepare"DPPs mandate full product traceability by 2027—ePI is pharma's compliance precursor. ForgeStop's platform ensures seamless readiness for both regulatory waves."

How Patients Will Access ePI

Once fully live, patients and healthcare providers will access ePI via:

  • QR codes or GS1 DataMatrix printed on packaging
  • App-free mobile experiences—scan with any device, no download required
  • Localized content, dynamically served based on location or device language

This is exactly what ForgeStop's InfoTap™ platform already enables: secure, touchless, app-free digital access to authenticated product information.

👉 Related: Product Authentication and Anti-Counterfeiting for the Pharmaceutical Industry"One scan now verifies authenticity AND delivers compliant information—collapsing anti-counterfeiting and patient safety into a single touchpoint."

The Challenge: Industrial-Grade Content Management

Delivering ePI isn't as simple as hosting a PDF. Pharma-grade digital product information demands:

  • Segmentation by batch, sub-batch, and unit
  • Audit-ready version control
  • Role-based views (patients vs. healthcare professionals)
  • Full compliance with EMA and regional regulations
  • Real-time localization and content updates

Most content management systems aren't built for this level of granularity. ForgeStop is.

ForgeStop: The ePI Delivery Engine

ForgeStop was designed from day one to deliver precision-controlled, compliant, and secure digital content. Here's how the platform powers ePI:

🔹 BatchMaker™ for Granular SegmentationDeliver targeted product info at batch, sub-batch, or even unit level—ensuring every scan links to the right content, every time.

🔹 Dynamic Smart Labels with IFTTT-Style LogicActivate rule-based content delivery: if geography = Germany, serve German PIL. If user = HCP, show SmPC. If batch = recalled, trigger alert. Simple configuration, infinite flexibility.

🔹 InfoTap™ PlatformApp-free, multilingual access with embedded audit trails—perfect for pharma-grade compliance and patient trust.

🔹 Real-Time UpdatesPush safety updates, regulatory changes, or localization fixes instantly—no reprinting, no recall, no delay.

🔹 Built-In AnalyticsTrack engagement, verify compliance, and generate ROI reports with supply chain-level visibility.

This infrastructure has already helped global pharma brands fight counterfeits and build trust across the supply chain.

Why ForgeStop Aligns with Your ePI Strategy

ForgeStop's mission—Protect. Connect. Experience.—maps directly to ePI requirements:

  • Protect: Ensure only compliant, current content reaches patients
  • Connect: Engage seamlessly through intelligent, trusted packaging
  • Experience: Deliver clarity, confidence, and care at every touchpoint

ePI isn't optional anymore—it's operational. And ForgeStop is ready.

👉 Related: Reducing Pharmaceutical Recalls with Smart Labels"Labeling errors trigger 20% of pharma recalls. Dynamic smart labels eliminate that risk with ePI-ready, real-time updates—already proven in live supply chains."

The Future of Pharma Is Digital—ForgeStop Is Already There

As regulators accelerate toward full digital compliance and packaging innovation, ForgeStop helps you deliver ePI confidently and at scale—without disrupting your existing supply chain or packaging operations.

If you're ready to modernize product information, enhance patient engagement, and exceed regulatory expectations...

Request a demo and discover how ForgeStop can ePI-proof your product line.

📘 Frequently Asked Questions

Why is NFC better than QR codes for ePI delivery?
QR codes can be photographed, copied, and reprinted — making them vulnerable to counterfeiting. NFC chips are embedded in the packaging and carry unique, unclonable identifiers. One tap authenticates the product AND delivers the ePI — no camera alignment, no app required. For pharma, where trust and security are non-negotiable, NFC closes the gap between "Is this real?" and "What's inside?" in a single touch.
Can existing ForgeStop clients add ePI to their smart label programs?
Yes. Many ForgeStop clients already use the platform for NFC authentication and smart labels. Adding ePI content delivery is a natural extension of the existing infrastructure—no new systems required. The same triggers, logic rules, and analytics that power anti-counterfeiting also power compliant ePI delivery.
How does ForgeStop support ePI compliance?
ForgeStop's platform delivers the right content to the right person at the right time — with full audit trails. Whether it's showing patients a PIL in their language or giving healthcare professionals the full SmPC, the system handles segmentation, localization, and real-time updates automatically.
What's the difference between ePI and paper leaflets?
Paper leaflets are static, single-language, and can only be updated by reprinting and recalling products. ePI is dynamic: it supports real-time safety updates, multiple languages, accessibility features, and structured data formats (FHIR) for healthcare system integration—all without touching physical packaging.
How do patients access ePI?
With ForgeStop Patients scan a NFC tag on the medicine packaging using any smartphone. This opens an app-free digital experience displaying the patient information leaflet (PIL) in their preferred language—no download required.
What is the timeline for ePI implementation?
The EMA pilot ran from July 2023 to August 2024, producing 23 ePIs. The pilot report (January 2025) recommended voluntary adoption for centrally authorized products. Throughout 2025-2026, essential functionalities including FHIR integration are being developed. Broader adoption is expected by 2027, aligned with Digital Product Passport deadlines.
Is ePI mandatory in the EU?
As of late 2025, ePI is in phased voluntary rollout following the EMA's successful pilot program. However, regulatory momentum suggests broader mandatory adoption is coming. Preparing now ensures compliance ahead of formal requirements.
What is ePI in simple terms?
ePI (Electronic Product Information) is the digital replacement for the paper leaflet inside medicine packs. It includes usage instructions, safety information, and regulatory data—delivered via NFC scan or QR instead of printed inserts.