TL;DR — in 60 seconds
- The EU has been officially building a digital leaflet ecosystem since 2018 — access layer, content management, patient page, anonymous analytics, regulatory bridge. PharmaTag operates inside that ecosystem from day one.
- Mobile access technologies on medicine packaging — QR codes, 2D barcodes and NFC — are formally authorised by EMA since November 2018 (EMA/493897/2015 Rev.1, in force today). They are the doorway, not the standard.
- The real standard is the electronic Product Information (ePI) framework: EMA / HMA / EC Key Principles (2020), codified by the 2023 Pharma Package revision (COM(2023) 192 and 193).
- On 11 December 2025 the Council and the European Parliament politically agreed on the reform. It is no longer speculative — it is adopted.
- The proposed Article 58 amendment mandates the EU ePI Common Standard for electronic leaflets, once operational. One standard, EU-wide.
- A Belgium–Luxembourg pilot on electronic-only leaflets in hospital settings is already underway — confirmed in the official EMA / HMA concept paper.
- Pharma MAHs who start piloting now secure a 2-3 year head start before progressive implementation rolls through in 2028-2030.
1 · What is EU ePI? The official definition
Electronic Product Information, or ePI, is not a PDF. It is not a QR code that points to a PDF. It is a structured, machine-readable dataset of authorised product information — the patient package leaflet, the Summary of Product Characteristics (SmPC), the labelling — encoded in a format that can be rendered across any device, language and channel.
The EMA / HMA Concept Paper on Product Information, prepared by experts from the European Medicines Agency and the Heads of Medicines Agencies to inform the 2023 Pharma Package revision, gives the exact definition:
« ePI is defined as authorised, statutory product information for medicines in a semi-structured format created using the common EU electronic standard. ePI is adapted for electronic handling and allows dissemination via the world wide web, e-platforms and print. »
Source: EMA / HMA / CMDh · Compendium of Concept Papers for the EU Pharmaceutical Reform, Concept Paper No. 12 — Product Information, Section 2.2 (Format of electronic product information).
Three implications for pharma MAHs:
- It is not just about digitising the paper. ePI is a structured XML-compatible dataset linked to EMA's SPOR (master data system for EU medicines). A PDF of your current leaflet is not ePI.
- One source, many outputs. The same ePI dataset renders on web, mobile, print, voice assistants, regulator portals, hospital systems — all from one authorised source of truth.
- EU-harmonised. The format is standardised so product information flows freely between Member States, agencies and platforms.
2 · The 2020 EMA / HMA / EC Key Principles on ePI
In late January 2020, the European Medicines Agency, the Heads of Medicines Agencies (HMA) and the European Commission jointly published the Key Principles on the Use of Electronic Product Information for EU Medicines (reference EMA/766923/2019). This is the foundational document of the ePI framework — every subsequent text refers back to it.
The document lays out seven principles that shape the EU's approach: harmonisation, interoperability, technology neutrality, patient safety, availability, multi-language support, and alignment with existing regulatory systems (SPOR, eSubmission, telematics). Any digital leaflet solution that does not align with these principles is, by definition, a dead end in the EU market.
The EMA published this document to make it unambiguously clear: the future of the patient leaflet is digital, harmonised, and structured. The rest is an implementation debate.
Read the official EMA Key Principles document (PDF)3 · The 2023 Pharma Package revision — COM(2023) 192 and 193
On 26 April 2023, the European Commission adopted the most significant reform of EU pharmaceutical legislation in 20 years. It comprises two instruments:
- COM(2023) 192 — Directive on the Union code relating to medicinal products for human use. This replaces and modernises Directive 2001/83/EC, the current backbone of EU pharma law.
- COM(2023) 193 — Regulation laying down Union procedures for authorisation and supervision of medicinal products, re-establishing the European Medicines Agency.
Together they re-write the rules on how medicines are authorised, supervised and presented to patients in the EU. Product Information — the package leaflet, the SmPC, the labelling — is one of the core areas being redesigned. And the direction is unambiguous:
« The provision of authorised electronic product information for EU medicinal products has been identified as a critical requirement to facilitate dissemination of medicines information to patients and healthcare professionals, enable easier access to data contained within the PI by regulators and stakeholders, and potentially increase efficiencies in the administration of PI. »
Source: EMA / HMA / CMDh · Concept Paper No. 12 — Product Information, Section 2 (Facilitating electronic product information).
4 · What Article 58 actually proposes
Article 58 of the current Directive 2001/83/EC makes the inclusion of a printed package leaflet in the packaging of a medicinal product mandatory. The 2023 reform proposes to amend this article to enable — for the first time in EU pharma law — electronic-only delivery of the package leaflet, at the discretion of each Member State.
The EMA / HMA concept paper lays out the exact proposed amendment:
« Taking into account the above-mentioned considerations, it is proposed to amend Art 58 to allow provision of information through mobile scanning technologies in specific cases, e.g.:
1. The inclusion in the packaging of all medicinal products of a package leaflet shall be obligatory unless all the information required by Articles 59 and 62 is directly conveyed on the outer packaging or on the immediate packaging or conveyed by other means as agreed by the Member State where the medicinal product is placed on the market.
2. Member States may decide that the package leaflet shall be made available on paper or electronically, or both.
3. Package leaflets made available electronically must comply with the EU ePI Common Standard once this standard is operational. »
Source: EMA / HMA / CMDh · Concept Paper No. 12 — Product Information, Section 2.4 (Proposed solutions — in legislation).
What this means in plain language
Paper and electronic will co-exist. Each Member State decides the pace. But the direction is one-way: every electronic package leaflet must comply with the EU ePI Common Standard — there will be no second technical standard. MAHs who build on the ePI Common Standard today are on the only durable path.
5 · The access layer is already EMA-authorised — since 2018
A persistent misconception in the pharma industry is that the digital leaflet is a "future technology" still waiting for EU validation. It is not. The access layer of the ecosystem — the mobile technologies that connect the carton to the electronic product information — is already formally recognised by the EMA for centrally authorised medicines, under a specific guidance in force since 2018.
PharmaTag is not just one technology. It is a full ecosystem that spans access hardware (NFC primarily, QR when appropriate), the web-based patient page, content management aligned with the EU ePI Common Standard, anonymous analytics under GDPR legitimate interest, and a regulatory bridge to variation and pharmacovigilance workflows. The EMA's 2018 guidance validates the access layer — the rest of the ecosystem executes inside the broader ePI framework the EU is now codifying.
« The use of mobile scanning and other technologies [...] to provide information [...] has been [increasingly requested] by applicants to the centralised procedure to use mobile scanning and other technologies, such as quick response (QR) codes and two-dimensional (2D) barcodes, or Near-field Communication (NFC), amongst others, as an additional way of providing information to patients and health care professionals. »
Source: EMA · Mobile scanning and other technologies in the labelling and package leaflet of centrally authorised medicinal products, EMA/493897/2015 Rev.1, 26 November 2018, Section 1 (Introduction).
This document sets out the formal acceptance criteria, submission procedure and CHMP assessment pathway for MAHs who wish to use NFC (or QR, 2D barcodes, etc.) in their labelling and package leaflets. It is already the regulatory path on which PharmaTag operates. Not a future guidance. Not a concept paper. A live EMA regulatory procedure.
Two additional provisions from the same document reinforce the fit with PharmaTag:
- EU-wide multi-language requirement (Section 4.1): "The mobile technology feature should be included in the labelling and/or PL in all the Member States, where the medicinal product is marketed, and the information should be provided in all the EU official languages of those Member States."
- GDPR responsibility built in (Section 6): "As the use of mobile technologies may involve the collection of personal data, applicants and MAHs are reminded of their obligation to observe the applicable data protection legislation, which includes Regulation (EU) 2016/679 [...] GDPR." This is exactly why PharmaTag's architecture collects zero first-party patient data — only anonymous scan behaviour.
The 2023 Pharma Package revision and the future EU ePI Common Standard take this foundation and expand it: from an additional route today to the standardised route tomorrow. The direction was unambiguous already in 2018. It is settled now.
And just so it's clear — the EMA/HMA Concept Paper confirms it again, explicitly
The later EMA / HMA / CMDh Concept Paper on Product Information re-confirms NFC among the recognised access technologies, this time in the context of the Pharma Package reform:
« The use of electronic package leaflets raises the question of how this information can be accessed by the patient, consumer and healthcare professional. Several mobile scanning and other technologies are in use or may be introduced in the future, including: QR codes, data matrix codes, bar codes (e.g. linear bar codes, 2D bar codes); Apps; URLs; Websites; Other innovative technologies such as near-field technology, virtual assistants, etc. »
Source: EMA / HMA / CMDh · Concept Paper No. 12 — Product Information, Section 2.1 (Accessing electronic product information).
And the Concept Paper goes further — stating that the use of mobile scanning technologies should expand to all medicinal products, not be restricted to hospital-only use cases:
« The use of mobile scanning or other technologies should be also gradually expanded in future for all medicinal products, not only for only 'hospital only products' or hospital packs. »
Source: EMA / HMA / CMDh · Concept Paper No. 12 — Product Information, Section 2.3 (Proposals considered).
Why this matters for pharma
NFC is not a vendor buzzword. It is named in the Commission's technical concept paper as one of the innovative access technologies the EU explicitly anticipates for ePI delivery. Pharma MAHs choosing between QR and NFC for their ePI strategy are not choosing between "official" and "experimental" — both are officially recognised. NFC offers frictionless tap-to-read, no app, no camera, on every modern smartphone in Europe.
QR vs NFC — the practical trade-offs
Both QR and NFC are explicitly supported by the EU legal framework. The differences lie in the patient experience and the brand signal:
- QR code: requires opening the camera app, framing the code, tapping a notification. Works on all smartphones with a camera. Occupies printed real estate on the pack. Patients in low-light or with reduced motor skills struggle.
- NFC chip: patient taps the back of the phone to the pack — zero friction, no app, no camera. Invisible from the outside (the chip is embedded in the carton). Unique URL per lot enables lot-level analytics and recalls. Premium brand signal. Works on every modern smartphone in Europe.
6 · The Belgium–Luxembourg pilot — already underway
One of the most consequential but under-reported passages in the entire EMA / HMA concept paper is a single sentence:
« Pilot programs are ongoing in some MSs, e.g. BE-LU and ES, on the use of electronic package leaflets only in the hospital setting. It is also proposed to run a pilot for medicinal products used outside hospital setting from sharing experiences and best practices for an EU harmonised ePI or 'electronically displayed package leaflet only instead of paper package leaflets' strategy. »
Source: EMA / HMA / CMDh · Concept Paper No. 12 — Product Information, Section 2.3 (Proposals considered).
Belgium–Luxembourg is one of only two EU pilot zones (the other is Spain). This is why PharmaTag is Belgian-headquartered, and why Belgian and Luxembourg pharma MAHs have a unique window to be early adopters of ePI with regulators who are actively testing the framework. The national authorities are already receptive; the infrastructure is already being tested.
7 · Readability, accessibility and the 30 million visually impaired
The CMDh readability guideline and the EU Accessibility Act (Directive 2019/882, enforcement since 28 June 2025) both apply to electronic leaflets. This is not a nice-to-have — it is a legal obligation that paper leaflets already struggle to meet.
According to the European Blind Union, approximately 30 million people in Europe are blind or partially sighted. For this population, a paper leaflet printed in 7-point type is effectively unreadable. An electronic leaflet with text-to-speech (TTS), zoomable text, high-contrast mode and multi-language audio is the only compliant path forward.
The compliance test for pharma MAHs
Does your current patient leaflet serve a 75-year-old senior with macular degeneration? Does it serve a blind patient? Does it serve a non-native speaker? If the answer is no, you have an accessibility compliance gap — not a future one, a present one. Electronic leaflets with TTS and multilingual support close that gap in a single step.
8 · GDPR — why ePI works without collecting patient data
A common concern among pharma Data Protection Officers is that digital leaflets force pharma to collect patient data. This is a misconception. Nothing in the ePI framework — not the Key Principles, not the proposed Article 58, not the EU ePI Common Standard — requires the collection of first-party patient data.
The ePI framework is about delivering statutory information to patients. Personalisation (beyond language and accessibility preferences) is not a prerequisite. Pharma MAHs can derive all the operational value of digital leaflets — live content updates, lot-level recall, scan-behaviour analytics, multi-language reach — using only anonymous, aggregated data, processed under the legitimate-interest basis of Article 6 GDPR.
The pharma brands who will win on ePI are the ones who treat their analytics as infrastructure, not as a marketing CRM in disguise. GDPR by design is a feature, not a constraint.
9 · Implementation roadmap for pharma MAHs — 6 steps
If your organisation has not yet started preparing for ePI, here is the sequence of actions we recommend to pharma and Consumer Health MAHs in the EU:
- Audit your leaflet estate. How many SKUs? Which languages? Which markets? Which leaflets meet the current CMDh readability guideline? This is the baseline against which every decision is made.
- Choose your ePI access technology. QR, NFC, or both. Consider UX (is the patient in a hospital, or at home in low light?), brand signal (is premium perception important?), analytics granularity (do you need lot-level data?) and smartphone compatibility (NFC compatible with every modern smartphone, QR requires camera access only).
- Align with the EU ePI Common Standard. The proposed Article 58(3) makes compliance mandatory. Any solution that is not ePI Common Standard-ready is not durable. Verify vendors on this point specifically.
- Integrate with pharmacovigilance and artwork workflows. ePI is not a marketing tool bolted onto the pack; it is a regulatory asset that must live inside your variation, artwork and pharmacovigilance workflows.
- Pilot on 1-3 SKUs first. Pediatric dosing, a chronic medication, or a multi-country Consumer Health product are ideal first-pilot categories. Measure scan volume, section read-depth, language distribution, expiry-alert engagement.
- Scale and expand. Once the first pilot clears internal stakeholders (Regulatory, QA, PV, DPO, Marketing, Supply Chain), the roll-out to the rest of the portfolio is mechanical. Each new SKU is a variation, not a project.
10 · FAQ — questions Regulatory directors are actually asking
Is a QR code on a medicine box enough for ePI compliance?
A QR code alone is not ePI. A QR code that points to a PDF is not ePI. The EU ePI Common Standard requires the underlying product information to be structured, machine-readable and compliant with the EMA specification. The access technology (QR, NFC, URL) is the delivery channel; ePI is the dataset behind it. Both are required for compliance.
Does ePI apply to Consumer Health and non-AMM products?
Not directly — the ePI framework applies to medicines with a Marketing Authorisation. However, Consumer Health brands subject to Directive 2001/83/EC, OTC and registered homeopathic products are inside the scope. Pure cosmetics, non-medical food supplements and free-sale products are outside the ePI framework but can still benefit from its infrastructure (analytics, accessibility, multi-language) without legislative obligation.
Will paper leaflets be banned?
No. The proposed Article 58(2) explicitly preserves paper: « Member States may decide that the package leaflet shall be made available on paper or electronically, or both. » The direction is additive, then substitutive over time. Paper and digital co-exist for the foreseeable future.
What is the risk of starting early?
Minimal. Any compliant ePI solution built on the EU ePI Common Standard today is compatible with the legislation tomorrow. The real risk is the opposite: being among the last pharma MAHs to implement, under regulatory pressure, during a flood of variations at 2028-2030 agency deadlines.
Looking for a compliant digital leaflet partner?
PharmaTag is the EU digital leaflet standard — NFC-chip on your carton, web-based patient page (no app download), 100% anonymous scan analytics, GDPR by design, aligned with EMA, HMA, CMDh and the proposed EU ePI Common Standard. Request a 30-minute demo with our team.
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Official sources cited in this article
- EMA · Mobile scanning and other technologies in the labelling and package leaflet of centrally authorised medicinal products (EMA/493897/2015 Rev.1, 26 November 2018). Explicitly recognises NFC, QR and 2D barcodes for EU centralised medicines. [EMA page]
- EMA / HMA / European Commission — Key Principles on the Use of Electronic Product Information for EU Medicines (EMA/766923/2019, late January 2020). [PDF]
- European Commission — Press release: Commission welcomes political agreement on major reform of EU pharmaceutical rules (11 December 2025, IP/25/3015). Political agreement reached by Council and Parliament. [Press release]
- European Commission — Digital Omnibus (COM(2025) 837, 19 November 2025). Reinforces GDPR Article 6(1)(f) legitimate interest and clarifies anonymisation scope.
- EMA / HMA / CMDh — Compendium of Concept Papers for the Pharmaceutical Reform (full document, multi-chapter). All direct quotes in Sections 1, 3, 4, 5 and 6 of this article are extracted from Concept Paper No. 12 — Product Information of this compendium.
- European Commission — Proposal for a Directive on the Union code relating to medicinal products for human use, COM(2023) 192, 26 April 2023. [EC page]
- European Commission — Proposal for a Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use, COM(2023) 193, 26 April 2023. [EC page]
- European Commission — DG Health — Reform of EU pharmaceutical legislation (overview portal). [EC page]
- CMDh — Readability guideline for the package leaflet of medicinal products for human use. [HMA page]
- European Blind Union — Statistics on blindness and partial sight in Europe. [EBU site]
- European Commission — Directive 2019/882 on accessibility requirements for products and services (EU Accessibility Act), enforcement 28 June 2025. [EC page]
- European Union — Regulation (EU) 2016/679 (GDPR), Article 6 legal bases for processing. [gdpr-info.eu]