In March 2026, the European Medicines Agency published what the pharmaceutical packaging industry has been waiting for — and dreading in equal measure: a draft implementation roadmap for electronic Product Information (ePI).

The roadmap converts years of pilots, consultations, and position papers into a concrete timeline. Vaccines (ATC code J07) go live on a voluntary basis in Q3 2026. Oncology products (ATC code L01, L04) follow in Q4 2026. All remaining Centrally Authorised Products progress to voluntary ePI submission after that, with a transition to mandatory ePI for all newly authorised medicines once the revised EU pharmaceutical legislation enters into application.

This is no longer a future consideration. It's a procurement decision that needs to happen now.

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What the EMA Roadmap Actually Says

The draft roadmap lays out a phased implementation across 2026–2028:

Q1–Q2 2026: Feature development, guidance publication, user acceptance testing, and PLM Portal enhancements. A June 2026 NCA workshop will define the final roadmap including timelines for National Competent Authority roll-out.

Q3 2026: Voluntary go-live for vaccines. Applicants begin authoring and uploading ePI through the PLM Portal as an additional step alongside current Word/PDF submissions.

Q4 2026: Voluntary go-live for oncology products. Progressive expansion to additional therapeutic areas follows.

2027–2028: Stabilisation, hypercare, IRIS-eSubmission integration, and full multilingual capabilities. NCAs conduct pre-implementation development to adapt national systems.

A few critical details stand out. Initial implementation will be English-only, with all other languages optional — full multilingual delivery comes later. Once a product's information is available in electronic format, it remains electronic for all subsequent variations. And ePI will be publicly available through the European Medicines Web Portal and accessible via API for third-party integration.

The EMA Management Board confirmed in March 2026 that ePI will become mandatory for all newly authorised medicines once the new pharmaceutical legislation takes effect. The voluntary phase is a runway — not an indefinite option.

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Why This Timeline Is Tighter Than It Looks

Six months sounds manageable. It's not — at least not for teams that haven't started.

Pharmaceutical packaging validation cycles run 6–12 months for any process change. If your ePI delivery strategy involves package linking — scanning a 2D code or tapping an NFC-enabled smart label to access digital product information — the technology decision, supplier qualification, and production line integration need to be in motion already.

The EMA's June 2025 reflection paper on package linking specifically explored how QR codes and NFC triggers on medicine packages connect patients to ePI content. That paper closed public consultation and is now informing implementation guidance. Package linking isn't an afterthought — it's baked into the regulatory architecture.

And the industry is already moving. A February 2026 survey by EFPIA, Medicines for Europe, and AESGP across 31 European countries found that 14 countries have active ePI pilots, 7 more are in planning, and the Belgium/Luxembourg pilot — running since 2018 — has distributed over 4 million packs with ePI, with 97% of hospital pharmacists reporting no issues from removing paper leaflets.

The question isn't whether ePI works. It's whether your packaging infrastructure can deliver it.

👉 Related reading: ePI Is Here: How ForgeStop's Smart Label Platform Delivers Compliant Digital Medicine Information at Scale — Our deep-dive on ePI fundamentals, FHIR standards, and how ForgeStop's InfoTap™ platform was purpose-built for real-time, multilingual, audit-ready ePI delivery across global pharmaceutical operations.

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The 6-Point ePI Compliance Checklist

For regulatory affairs directors, packaging engineers, and operations leaders preparing for the Q4 2026 window, here's what needs to be in progress now:

1. Audit your PIL/SmPC workflow for FHIR compatibility. The EU ePI Common Standard is built on Fast Healthcare Interoperability Resources (FHIR). If your product information still lives in Word documents and PDFs — and for most companies it does — you need a structured data migration path. The PLM Portal will require ePI authoring alongside your current submissions, not instead of them.

2. Evaluate your package linking technology. The EMA's reflection paper explored both 2D codes and NFC as triggers for ePI access. QR codes are the default assumption, but NFC smart labels offer advantages that matter at scale: they're unclonable (critical for authentication), don't require line-of-sight scanning, and can deliver dynamic, personalised content based on location, language, and user context — all without requiring an app download.

3. Select a digital content management platform for ePI hosting. The EMA will host ePI on the European Medicines Web Portal and make it available via API. But brands that want to control the patient experience — multilingual delivery, branded interfaces, integrated authentication, usage analytics — need their own content infrastructure sitting behind that package link.

4. Map multilingual content delivery requirements by market. Initial CAP implementation is English-only, but the roadmap explicitly calls for full multilingual capability at a later stage. Markets with active NCA pilots (Nordic countries, Spain, Netherlands, Portugal) may have earlier requirements. Your platform needs to serve the right language, in the right format, to the right market — automatically.

5. Align ePI infrastructure with DPP 2027 readiness. The EU's Digital Product Passport mandate hits pharmaceutical packaging by 2027. ePI and DPP share the same fundamental requirement: machine-readable, updateable, verifiable product data accessible from the physical package. Brands building infrastructure for one should be building for both.

👉 Related reading: Digital Product Passports (DPP): What They Are and How ForgeStop Helps Brands Prepare — ePI and DPP share the same digital backbone. Brands investing in one compliance layer are already halfway to the other — here's how to converge both timelines into a single infrastructure decision.

6. Establish audit trail and reporting capabilities. Regulatory submissions will require documentation of how ePI was created, managed, and delivered. Your platform needs timestamped records of content versions, access events, and update propagation — not just for regulators, but for your own quality management system.

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Smart Labels Solve the Last-Mile Problem

Here's the gap that most ePI implementation discussions overlook: content management platforms can structure and host ePI data, but patients still need a physical trigger on the medicine package to access it.

That's the role of the smart label.

NFC-enabled smart labels embedded in pharmaceutical packaging create a tap-to-access experience. A patient or pharmacist holds their smartphone to the package — no app required — and receives the current, localised electronic product information for that specific product in real time. Authentication happens simultaneously: the NFC chip verifies the product is genuine before any content is delivered.

This is exactly what ForgeStop's InfoTap™ platform delivers today. The same infrastructure that pharmaceutical companies use for product authentication — unique chip IDs, cloud-connected verification, real-time analytics — is the infrastructure that ePI requires for package linking. One platform. Two compliance mandates solved.

And because NFC smart labels are embedded during the label lamination process, existing packaging lines don't need to be redesigned. The label looks the same, applies the same way, and adds less than 0.3mm of thickness. What changes is what happens when someone taps it.

👉 Related reading: Reducing Pharmaceutical Recalls with Smart Labels: A Digital Solution to Labeling Errors — Labeling errors drive a significant share of pharmaceutical recalls. Dynamic smart labels with ePI-ready content delivery eliminate that risk by ensuring patients always access the current, approved product information — not whatever was printed months ago.

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The Window Is Narrow

The EMA's March 2026 roadmap isn't a proposal — it's an implementation plan. Vaccines in Q3. Oncology in Q4. All CAPs progressively after that. And once the revised pharmaceutical legislation is formally adopted, ePI becomes mandatory for every newly authorised medicine in the EU.

Pharmaceutical manufacturers that treat this as a 2028 problem will find themselves retrofitting packaging infrastructure under regulatory pressure. Those that act now — selecting their package linking technology, qualifying their content management platform, and integrating smart label infrastructure into validated production lines — will be the ones delivering compliant ePI before the deadline, not scrambling to meet it.

The roadmap is published. The timeline is set. The only remaining question is whether your packaging is ready to deliver what regulators, pharmacists, and patients are about to expect from every medicine box they touch.

Talk to ForgeStop about ePI-ready smart label infrastructure →

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¹ EFPIA, Medicines for Europe, and AESGP, "Digital Leap: Industry Proposes Phased Rollout of ePI for Patient Safety and Environmental Sustainability" — Joint position paper, January 2025. The three industry bodies recommend ePI be fully operational within four years after entry into force of the revised General Pharmaceutical Legislation, with paper leaflets phased out progressively.