ePIL plans are progressing in both the UK and the EU. The aim is to make medicines information easier to access and easier to use, while also helping to reduce paper waste. But the message from regulators is still clear: paper leaflets are not going away any time soon. For now, digital information is being developed to sit alongside the printed leaflet, not replace it.
A quick note on the terminology
What is electronic Product Information (ePI)? – ePI is the digital version of a medicine’s authorised product information (SmPC, leaflet and label)
What is an electronic Patient Information Leaflet (ePIL)? ePIL is more specific. It means the patient information leaflet only, but in digital form so it can be easier to access and search online.
This article focuses on the ePIL, because that is the part most relevant to patients and to any future move away from paper leaflets, and also, it’s what we all want to know about!
What is the ePIL status in the UK?
In the UK, the MHRA is running its Improving Patient Information project. The project has three stages:
- Phase 1 is completed and was used to understand current use and develop an action plan
- Phase 2 is preparing to launch and runs from 2026 to 2027. This stage will put governance in place and start delivering that plan – if you’d like to take part in this you can by emailing IPI@mhra.gov.uk
- Phase 3 runs from 2027 to 2028 and will review the impact and shape the longer-term approach.
The MHRA will share updates through the UK ePI Task Force. This Task Force is made up of a group of UK medicines manufacturers and is led by three industry associations, Medicines UK, ABPI and PAGB.
This work is being supported by wider evidence that digital access is becoming more relevant. The UK ePI Task Force says that 77% of people in a recent survey preferred medicines information online, compared with 13% who preferred printed information. At the same time, the Task Force also recognises that some people are unable to access information digitally, so a non-digital option will still need to remain available.
What is the ePIL status in the EU?
In the EU, EMA is further ahead on the framework for ePI. In April 2026, EMA also published its draft ePI roadmap, which sets out phased implementation. Including voluntary go-live for vaccines and oncology products in 2026, and voluntary go-live for all CAPs in H2 2027.
It is worth noting that EMA does not currently discuss ePIL specifically. Instead, digital leaflet content is addressed as part of the broader ePI framework. Existing guidance focuses mainly on how patients can access product information electronically, for example through QR codes or other mobile technologies.
How will ePILs actually work?
The detail is still being worked through. Current EMA guidance on mobile scanning and other technologies, states tools such as QR codes, 2D barcodes and other mobile technologies can be used to provide additional information, but they “cannot replace statutory information such as the printed package leaflet”. The same guidance also says digital content may be hosted by the MAH, a national competent authority, or a third party acting on their behalf.
There is also growing interest in using the 2D matrix already on pack to help users reach digital information. GS1 Digital Link is a standard that connects product identifiers to online information. In healthcare, the concept is to make better use of the 2D code already on pack, rather than adding extra codes wherever possible. One current example is scanning via Google Lens, which can open a “trusted source of medicine information from the manufacturer or an authorised data provider.” But there is not one single mandatory destination for every product.
A further practical question is how quickly approved PIL changes could appear online after a marketing authorisation or variation is approved? If content is linked to the MHRA database, there may be a delay between approval and the updated leaflet appearing online. One alternative source is the electronic medicines compendium (emc), but those updates depend on the pharmaceutical company uploading them, and not all companies use emc. This means the source of information, the speed of updates and the data shown through a scanned 2D code may still vary from one product to another.
For regulatory affairs and quality teams, that means the direction of travel is positive, but some practical questions remain open. Companies will need to keep an eye on where digital content is hosted, how quickly updates appear online after approval, and how the online version stays aligned with the approved product information. Current guidance makes clear that responsibility for the product information remains with the MAH, and that electronic information must be kept up to date, but the overall operating model is still taking shape.
What is the main takeaway?
The main message is clear: ePIL is progressing, but there is still a lot to work through before the picture is clear. For the foreseeable future, companies should plan for a hybrid model, with the printed leaflet still required, with digital access developing alongside it.
If your team would like help understanding what these developments mean for your products, product information maintenance or future digital readiness, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.
