Pharma companies across the EU are facing a growing pressure that many still underestimate. The shift toward ePI requirements is not just another regulatory update, but a fundamental change in how product information must be created, managed and delivered. Under the new legislation, structured electronic product information is becoming a formal requirement, replacing static documents and forcing companies to rethink their entire data approach.
The problem is that most organisations are not built for this. Their processes rely on documents, manual updates and disconnected systems, which simply do not align with what ePI requirements demand. As timelines move closer — with the new legislation expected to formally enter into force later in 2026 following its political agreement in December 2025, and a full transition period running until 2028 — the gap between current capabilities and required readiness is becoming more visible. This creates a real risk. Delays in adapting to ePI requirements do not just mean compliance issues. They can lead to submission delays, inconsistent product information and increased operational costs at a time when speed and accuracy are critical.
And here is the uncomfortable reality. The longer companies wait, the harder and more expensive the transition becomes. What looks like a manageable regulatory change today quickly turns into a complex transformation project tomorrow.
What companies must do to comply with ePI requirements
Meeting ePI requirements is not about making small adjustments. It requires companies to fundamentally change how product information is created, managed and distributed across the entire organisation.
The first step is shifting from documents to structured data. ePI is based on the EU ePI Common Standard, which uses the HL7 FHIR (Fast Healthcare Interoperability Resources) international standard to define how product information must be organised in a machine-readable, interoperable format. This means companies can no longer rely on Word or PDF as the source of truth. Instead, SmPCs, package leaflets and labelling must be broken down into structured data elements that can be reused, updated and shared across systems — and accessed via API by third parties including healthcare platforms and e-prescribing tools.
At the same time, companies need to rethink their systems. ePI is designed to integrate with regulatory platforms, product lifecycle management tools and external healthcare systems. Without proper integration, updates become inconsistent and compliance risk increases quickly.
Process redesign is equally critical. ePI is not a one-time submission but part of ongoing regulatory procedures. It must be created, validated and updated alongside every variation or lifecycle change. That requires clear governance, ownership and control across teams.
Finally, companies need to align with the ePI implementation timeline — and that timeline is now concrete. EMA’s draft roadmap, published in March 2026, sets voluntary go-live for vaccines in Q3 2026 and oncology products in Q4 2026. Further therapeutic areas will follow progressively. Once the new pharmaceutical legislation formally enters into application, ePI will become mandatory for all newly authorised medicines. Waiting for full enforcement is not a safe strategy, because preparation, system validation and organisational change take significantly longer than expected.
In reality, complying with ePI requirements means building a new operational capability. Those who treat it as a structured transformation will be ready. Those who treat it as a document conversion exercise will struggle to keep up.
How Billev Pharma East helps you take control of epi requirements
to control, and from manual, fragmented work to something that actually holds together under pressure. Most companies already know what ePI requirements are. The challenge is making them work in real life, across messy data, legacy systems and day-to-day regulatory pressure.
At Billev Pharma East, we work with ePI requirements in practice, not just in theory. We have been directly involved in the EU ePI pilot environment, working on real regulatory procedures where electronic product information is created, tested and managed as part of actual submissions. That experience changes the approach. Because once you have seen how ePI behaves in real workflows, you stop thinking about it as a format and start treating it as a system.
We take your current setup and turn it into something that is structured, connected and ready for ePI. That means transforming product information into FHIR-compliant formats, aligning it with regulatory expectations, and making sure it works across your systems without creating additional complexity. At the same time, we build processes that can handle ongoing updates, not just one submission.
What makes the difference is that we do not treat this as a standalone project. We cover regulatory affairs, pharmacovigilance, quality systems and digital consultancy, so ePI requirements are built into how your organisation actually works.
The result is simple. You move from uncertainty.
What really matters when preparing for epi requirements under the new EU legislation
The key thing to understand is that ePI requirements are not coming in isolation. They are part of a much broader shift introduced by the new EU pharmaceutical legislation, which fundamentally changes how product information is managed across the entire lifecycle of a medicine.
The timeline alone should change how companies think about preparation. A political agreement was reached on 11 December 2025. The compromise text was published in March 2026, with formal adoption and entry into force expected later in 2026 following publication in the Official Journal of the EU. A two-year transition period then runs until 2028, during which companies must adapt systems, processes and national laws. But the timeline is only part of the story. The legislation explicitly pushes the industry toward digitalisation and more efficient, structured handling of product information. This is where ePI requirements come in. They are not just a technical add-on, but a direct consequence of this shift toward digital, connected regulatory processes.
What matters most is how early companies start. The framework allows approximately 24 months for implementation and national transposition, but in reality, this time is already being filled with implementing acts, guidance development, system updates and internal change programmes. Waiting for final details is risky, because by then, the execution window is already shrinking.
Another important point is scope. This legislation does not just introduce new rules. It replaces core directives and regulations that have been in place for over two decades — specifically Regulation (EC) No 726/2004 and Directive 2001/83/EC — affecting everything from development to safety monitoring and product information management. That means ePI requirements must be aligned with a much wider regulatory transformation, not treated separately.
In practice, the companies that succeed will be the ones that connect the dots early. They will not wait for full enforcement, but start building the capabilities now, while the framework is still being implemented. Because under this new legislation, compliance is not about reacting. It is about being ready before the rules fully apply.
Why ePI requirements are just one piece of a much bigger regulatory shift
It is easy to focus only on ePI requirements, but that would miss the bigger picture. What is happening now is not a single requirement being introduced, but a complete reset of the EU pharmaceutical framework. The new legislation replaces the core legal backbone that has been in place for over 20 years, including Directive 2001/83/EC and Regulation (EC) No 726/2004. This means companies are not just adapting to new rules — they are transitioning into a new regulatory system altogether.
One of the most important implications is the scale of what comes next. The legislation itself is only the starting point. Over the following years, the European Commission, EMA and Member States will develop a large number of implementing and delegated acts, along with detailed guidance and technical standards to make the system operational.
At the same time, Member States will need to transpose the Directive into national law, which adds another layer of complexity and variation across markets. This is where ePI requirements become critical. They sit right at the intersection of this transformation, linking regulatory data, digital systems and product lifecycle management. But they cannot be addressed in isolation, because they depend on how the rest of the framework is implemented.
Another important shift is the focus on efficiency and digitalisation. The reform is explicitly designed to reduce administrative burden, streamline procedures and modernise how medicines are evaluated and managed. That means companies will be expected to operate faster, with more structured data and less manual handling.
In practical terms, this creates a moving target. While the high-level rules are known, the detailed requirements will continue to evolve over the next two to three years. So the real challenge is not just understanding ePI requirements, but preparing for a regulatory environment that is still being built.
Be ready before ePI requirements become business-critical
The direction is already clear. The new EU pharmaceutical legislation is not just an update, but a structural shift toward digital, faster and more integrated regulatory processes. Political agreement was reached in December 2025, the compromise text was published in March 2026, and formal entry into force is expected later in 2026 once the text is formally adopted and published in the Official Journal. A two-year transition period then runs until 2028, with a compressed implementation window in between.
That means ePI requirements are no longer something to “monitor”. They are something to act on now. EMA’s draft ePI roadmap sets voluntary go-live for vaccines in Q3 2026 and oncology in Q4 2026 — with expansion to all remaining Centrally Authorised Products following shortly after. Companies that are not preparing today will not be ready.
Companies that move early will have time to design their systems, align their data and build processes that actually work. Those that wait will be forced to react under pressure, with higher costs and greater risk of delays or inconsistencies. This is exactly where the difference is made.
At Billev Pharma East, we help you turn ePI requirements into something practical, controlled and ready for real-world regulatory use. We do not just prepare you for compliance. We make sure your organisation is set up to handle what comes next, as the legislation continues to evolve.
Read also
- What to consider for your upcoming EPI implementation / E-Labelling implementation in line with EMA labelling guidelines
- Choosing the right EPI solution? Start with the PLM Portal
- What is structured product labeling and why is it essential for high-quality EPI?
Sources: 1 – European Medicines Agency (EMA). Reform of the EU pharmaceutical legislation. 2 – European Medicines Agency (EMA). (2025, December 11). EMA welcomes political agreement on new EU pharmaceutical legislation. 3 – European Parliament. (2025, December). Deal on comprehensive reform of EU pharmaceutical legislation. 4 – Council of the European Union. (2025, December 11). Pharma package: Council and Parliament reach a deal. 5 – European Medicines Agency (EMA). Electronic product information (ePI). 6 – EFPIA, AESGP & Medicines for Europe. (2025, January 8). Digital leap: Industry proposes phased rollout of ePI. 7 – European Medicines Agency (EMA). (2026, March). Draft ePI Implementation Roadmap. 8 – European Medicines Agency (EMA). (2026, March). EMA Management Board highlights – March 2026 meeting.
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