Key takeaway
ePI and e-labelling are not the same thing. What the EU pharma package changes for package leaflets, where other regions already are, and why a Deputy QPPV says the missing piece is an app.
Short answer: Electronic product information (ePI) is the EU's structured, machine-readable format for the summary of product characteristics, labelling and package leaflet, built on the FHIR standard. E-labelling is something simpler: a digital version of the paper leaflet that patients can open from a code on the pack. Europe has the format, a completed pilot and, with the new pharmaceutical legislation, a legal basis. What it still lacks is a single, patient-facing way to get from the pack to the leaflet, and a decision in each Member State on whether paper can go.
In EMA's terms, ePI is "authorised, statutory product information for medicines" in a structured electronic format. It covers the summary of product characteristics (SmPC) for healthcare professionals, the labelling and the package leaflet for patients. The EU ePI Common Standard is based on HL7 FHIR, the same standard used for electronic health records, so the content can be read by apps, websites and hospital systems rather than copied from a PDF.
EMA, the Heads of Medicines Agencies and the European Commission ran a pilot from July 2023 to August 2024 with Denmark, the Netherlands, Spain and Sweden, publishing 23 ePIs from real procedures. The pilot report, published in December 2024, concluded that the system was "generally prepared for the introduction of ePI" and recommended starting with voluntary adoption for centrally authorised products (EMA).
The two terms are used as if they meant the same thing, and they do not. Lollike made the distinction his opening point: "E-labelling means digitalising the paper leaflet that comes with the drug package." By contrast, "Electronic Product Information e(PI) is – in EMA terms – something else."
E-labelling, also called ePIL, eLeaflet or eIFU, is the patient-facing outcome: a leaflet you can read on a phone, usually by scanning a code on the pack. ePI is the regulatory data format that makes that leaflet, and every other piece of product information, structured and machine-readable. In his summary: "EMA has focused on ePI as the underlying technology to facilitate e-Labelling". One is the pipe; the other is the tap.
Lollike asked the audience two questions. "What is the biggest overall safety issue we are facing in Europe right now?" And: "How long time does it take from decision to update a label until the updated label is in the hands of the patient?"
The second question is the heart of the safety case. When a regulator approves a change to a leaflet, the new text has to be printed and packed, and old stock has to sell through before patients see it. A digital leaflet can be updated the day the change is approved. The UK's Consumer Healthcare Association makes the same point in its 2026 paper on electronic leaflets, noting that paper updates "can lag by months", and estimates that about 3.5 billion paper leaflets are printed for Great Britain each year. In its survey, 71% of people said they would be happy to read a leaflet online.
There are other benefits along the value chain, which Lollike grouped by patients, industry, authorities and the environment: searchable text in large fonts and many languages, fewer repackaging operations, and less waste. Industry's own figures, prepared by Deloitte for EFPIA, put the carbon saving from removing paper leaflets across the EU market at more than 700,000 tonnes of CO2 equivalent (2025, industry-commissioned).
It also helps with shortages. Multilingual packs can move between countries when supply is short, and the leaflet in the patient's language is a scan away. The European Court of Auditors counted 136 critical shortages reported in the EU between 2022 and October 2024, and the Critical Medicines Act, agreed in May 2026, is expected to apply from the end of 2026.
At the 5th Pharmacovigilance & Drug Safety Conference in Madrid in April 2026, Karsten Lollike, Scientific VP and Deputy QPPV at Novo Nordisk, gave a tour of e-labelling around the world and asked why Europe is behind. His conclusion was blunt:
"We need somebody to take responsibility to develop technology - app - to link e-Labelling to ePI in Europe"
Karsten Lollike, Scientific VP and Deputy QPPV, Novo Nordisk, 5th Pharmacovigilance & Drug Safety Conference, April 2026
His presentation listed what Europe has: the ePI format, pilots, and now a legal basis in the pharma package. What it lacks is the patient-facing layer. EMA's draft reflection paper on linking packs to ePI, which he summarised, points to using the existing DataMatrix code that already serves the falsified medicines system, preferring HTML over PDF, excluding promotional content, consolidating on one app for simplicity, and involving patients and HCPs in testing. Regulators, in his words, "encourage industry–led initiative to create solution".
The obstacles he named will be familiar to anyone who has sat in a working group: "Evolving technology, but access to internet still a challenge in some regions", regulations still under development, pilots with different scopes and "many national variations", variable technical standards, and three open questions: "What about patients without access? Print out at Pharmacy? Who to pay?"
Lollike's map showed "54+ Pioneer Markets experimenting with eLabelling" and summed it up: "E-Labelling is already here in several countries, and more countries are joining all the time".
The revised General Pharmaceutical Legislation, politically agreed on 11 December 2025, gives e-labelling a legal basis for the first time. According to the text Lollike presented and the Council's position of 28 September 2026:
The timelines are the open question. Lollike's presentation noted that 18, 24 and 36 months were on the table. The Commission and EMA's October 2026 slides describe an implementing act on electronic leaflet standards due 18 months after entry into force, with the leaflet provisions applying from around Q2 2028. Parliament's final vote and publication in the Official Journal were still pending in autumn 2026.
For what this means for the person accountable for product safety, see What Does a QPPV Do? The Role Explained for 2026.
EMA's draft roadmap, first published in March 2026, sets out a phased go-live for centrally authorised products from Q4 2026: vaccines first, then oncology medicines, then all centrally authorised products, with English first and other languages optional during the voluntary phase. Guidance for applicants followed in September 2026, with industry user testing before a go/no-go decision on the Q4 launch (RAPS). National roll-out is pencilled in for 2027 and 2028. EMA has said that ePI will eventually become mandatory for newly authorised medicines, and that submission in all languages will follow.
These topics will be on the agenda at the 6th Pharmacovigilance & Drug Safety Conference in Barcelona on 27–28 April 2027.
Header photo: Christine Sandu on Unsplash.
ePI stands for electronic product information: the EU's structured, machine-readable format for the summary of product characteristics, labelling and package leaflet, based on the HL7 FHIR standard.
No. E-labelling is a digital version of the patient leaflet, usually opened by scanning a code on the pack. ePI is the underlying data format that makes product information structured and machine-readable. ePI enables e-labelling, but a country can allow e-labelling without ePI.
Not automatically. The new EU pharmaceutical legislation keeps the paper leaflet mandatory alongside an electronic version. Each Member State can decide to go electronic-only for some or all medicines, provided patients can get a free printed copy on request.
EMA's draft roadmap starts a voluntary phase for centrally authorised products from Q4 2026, beginning with vaccines. EMA has said ePI will become mandatory for newly authorised medicines, with national roll-out planned for 2027 and 2028.
Japan has allowed paperless package inserts since 2021. Gulf states require electronic leaflets with QR codes on packs, and Taiwan and Malaysia are phasing in e-labelling with paper on request. The US does not yet allow electronic-only labelling.
The Pharmacovigilance & Drug Safety Conference, organised by UBIQ Events, brings together QPPVs, regulatory and drug safety leaders. The 6th edition takes place in Barcelona on 27–28 April 2027.
