From Paper to Platform: What Electronic Product Information (ePI) Really Means for Labeling Teams

On September 1, the EMA published guidance on submitting electronic product information through its PLM Portal. Like many procedural updates, it would have been easy for regulatory affairs teams to skim it and move on.

But there’s an important change behind the guidance. Patient information leaflets, Summaries of Product Characteristics (SmPCs) and other product information have traditionally been managed as documents: drafted, reviewed, approved and sent for printing. Electronic product information (ePI) introduces a different way of managing that content, with defined statuses such as Draft, Submitted and Deactivated, and a growing role for digital processes in how product information is maintained.

That matters because product information can no longer be treated as finished once a document has been approved and published. It needs to be managed as a controlled record, with clear oversight of its status and ongoing changes.

The difference between a document and a dataset

Under the EU’s ePI Common Standard, electronic product information is more than a digital copy of an existing leaflet. It uses structured data based on HL7 FHIR (Fast Healthcare Interoperability Resources), allowing information to be searched, filtered and processed by digital systems, as well as accessed by patients and healthcare professionals. Simply uploading a PDF or converting a Word document into a digital file doesn’t achieve this; the information must follow the required structure and standard.

This also changes how pharmaceutical companies need to think about maintaining product information. Once content is held as structured data and linked to a regulatory record, it needs to remain consistent with the latest approved information. That means managing updates, versions and changes throughout the product’s lifecycle, rather than treating approval and publication as the end of the process.

What the September guidance actually asks of you

EMA’s guidance sets out several practical requirements for submitting and maintaining electronic product information (ePI). While submission is currently voluntary, there are specific rules around how records must be prepared, submitted and updated.

During the voluntary phase, ePI can be submitted in English, although multilingual product information will become increasingly important as the approach develops. Submissions are made through the PLM Portal, and reaching the correct status depends on getting the details right. The ePI must match the final approved annexes, the procedure number must be entered correctly, and the record must be set to ‘Submitted’ rather than left in ‘Draft’. New marketing authorization applications can remain in Draft status, while other procedures, including variations, renewals and transfers, follow different submission requirements.

There’s also a deadline to keep in mind when a marketing authorization is withdrawn or an application receives a negative opinion. According to the EMA guidance, the associated ePI must be moved out of Submitted status, either to Deactivated or back to Draft, within 15 working days of the EMA’s notification. For companies managing multiple products, markets and language versions, keeping track of these changes could become challenging without clear ownership and reliable processes.

This is where lifecycle management becomes important. Product information needs to be monitored and updated as regulatory circumstances change, with the right status, version and supporting information maintained throughout. As ePI develops, pharmaceutical companies will need to consider how their existing content management processes can support these requirements.

Who’s affected, and when

Nothing here is mandatory yet, and nothing happens overnight. The rollout is explicitly staged:

Member States will still decide, for now, whether a given leaflet is paper, electronic, or both — and patients keep the right to request a printed copy regardless. Industry bodies like EFPIA have actually pushed for ePI to be phased in well before paper is phased out, precisely because nobody wants a gap where neither format is reliably available. So if you’re picturing a cliff edge where paper leaflets vanish overnight, that isn’t the plan, and it’s worth saying plainly: there’s no reason to panic-restructure anything this quarter.

What’s actually worth doing now

The organizations that will find this easy aren’t the ones who move fastest — they’re the ones whose product information already lives as structured, version-controlled data rather than static files scattered across departments. 

However, if their product information lives in a mix of Word documents, email threads, and whichever folder someone last saved to — this is a reasonable moment for those businesses to start closing that gap. Not because the deadline is close, but because the deadline being staged out over two years is exactly the kind of runway that gets wasted if nobody starts using it.

Prepare your business for ePI

If your product information is still scattered across shared drives, PDFs, and email threads waiting for final sign-off, the two-year runway on ePI is exactly the kind of deadline that gets missed by accident, not by neglect.

Veraciti™ keeps your label and artwork data as a single managed source of truth — version-controlled, audit-ready, and built to stay in sync the moment something changes, whether that change comes from the EMA, a new market, or your own regulatory affairs team. Speak to one of our labeling and artwork experts by filling in a form here or book a demo here.

Read more on how ePI affects labeling, or learn how Kallik works.