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How does e-labelling help us understand what is electronic product information?

What is Electronic Product Information?

Outdated paper leaflets no longer meet the demands of fast-changing healthcare environments, where accuracy, accessibility, and compliance are critical. As industries transition to e-labelling, more decision-makers are asking: what is electronic product information and how can it streamline both regulatory and user needs? The answer lies in digital formats that reduce waste, ensure real-time updates, and transform how we communicate trusted product data.

What is electronic product information and why does it matter today?

In the pharmaceutical world, electronic product information (ePI) marks a significant evolution from static paper leaflets to dynamic, digital formats. ePI improves access to up-to-date, regulated content like dosage, safety, and product use—empowering patients and professionals alike.

Electronic product information (ePI) refers to the authorised, statutory product information for medicines (including the summary of product characteristics, package leaflet and labelling) adapted for handling in electronic format and dissemination via the web, e-platforms and in print (if required).

Transitioning to ePI offers advantages such as improved accessibility, searchability and multilingual capabilities.

ePI can also integrate with electronic healthcare systems, enabling healthcare professionals and patients to access accurate and up-to-date product information more conveniently.

As seen on the Billev Pharma East website, companies can contact our experts and already start transforming their business processes to streamline transition to ePI to reach regulatory compliance. By aligning with XML and FHIR standards, ePI becomes machine-readable and integrable into eHealth ecosystems—crucial in modern healthcare.

Why does this matter now? Because regulators like EMA and FDA are pushing for digitisation. In a post-pandemic world, access to trusted, immediate data—especially online—is no longer optional. It’s expected. ePI enhances safety by ensuring that any changes (e.g. new contraindications or updates in dosage) are immediately reflected in the material patients receive.

Beyond accuracy, ePI brings sustainability: no more printed updates, shipping leaflets, or overpackaging. For global companies, it reduces costs, logistics burdens, and the risk of outdated translations in foreign markets.

How is e-labelling changing the way we access product details?

E-labelling represents a major shift from static, printed packaging inserts to dynamic, digital solutions that deliver up-to-date product information instantly. With increasing pressure on the life sciences industry to comply with evolving regulations and reduce packaging waste, digital labelling is becoming not only an innovation—but a necessity.

Through platforms which represent single source of trusted information, manufacturers and regulators are embracing structured, multilingual data delivery that meets EU and global compliance standards. These systems support XML-based formats, allow real-time updates, and are accessible via QR or 2D matrix codes or digital health portals.

From a compliance standpoint, e-labelling ensures that only approved and current content is shared, reducing risks of outdated information reaching patients. For users, it improves accessibility—especially for those with visual impairments or in multilingual markets—by offering responsive, searchable formats accessible on any device.

At Billev Pharma East, we see how e-labelling ultimately closes the gap between regulatory control and user-centric delivery. It simplifies updates, enhances safety, and transforms packaging into a smart access point for real-time medical knowledge.

Can e-labelling improve compliance and user experience at the same time?

Definitely. Traditionally, compliance and usability stood at opposite ends. Now, e-labelling makes it possible to do both. Digital formats allow embedded hyperlinks, up-to-date safety warnings, regulatory approved translations, which reduce medical errors and improve understanding.

At the same time, automated version control ensures that only the most current label is shown—meeting regulatory requirements in real time. Labels become traceable and auditable, easing the compliance burden while improving end-user confidence.

e-labelling is not just legal alignment—it’s patient-centric innovation.

Bridging compliance and UX through e-labelling and electronic product information

Modern healthcare requires a balance between strict regulatory compliance and intuitive user experience. With the rise of e-labelling and structured electronic product information, this balance is not only achievable—it’s becoming the new standard.

Digital formats enable real-time updates, accessible content, and enhanced traceability, all while improving how patients and healthcare providers interact with medicine-related information. Instead of static paper leaflets, users access tailored data through apps, QR or 2D matrix codes, or secure web portals—updated as needed and available in multiple languages.

The following table illustrates key ways in which e-labelling and ePI enhance both compliance and UX:

FeatureCompliance BenefitUser Experience Benefit
Real-time version controlEnsures only the latest, approved label is usedUsers always see accurate, up-to-date information
XML/FHIR structured formatsMeets EMA/FDA electronic submission standardsEnables fast, machine-readable data on digital devices
Multilingual digital accessSupports regional regulatory requirements (EU multilingualism)Allows patients to access info in their native language
Embedded QR or 2D matrix codes on packagingEnables verification of data source and traceabilityEasy scanning for instant access to information
Interactive digital designReduces risk of misinterpretation through validated templatesImproves readability, accessibility (e.g., adjustable font size)
Automatic audit logsCreates verifiable compliance records for inspectionsBuilds trust and transparency with end users

By integrating both regulatory and UX thinking, electronic product information and e-labelling empower manufacturers to meet strict standards while offering a modern, patient-centered experience.

What industries benefit most from switching to e-labelling?

While pharma and medtech are clear frontrunners, several industries see tangible gains from e-labelling:

  • pharmaceuticals: real-time updates, international rollout of SmPCs and PILs.
  • Medical devices: digital IFUs as required by EU MDR.
  • Veterinary medicine: species-specific instructions made more intuitive.
  • Food supplements: transparency on allergens and ingredient sourcing.
  • Industrial chemicals: always-accessible safety data sheets (SDS).

Wherever information must be precise, current, and multilingual, e-labelling brings efficiency
and clarity.

E-labelling

How does e-labelling support sustainability in product packaging?

E-labelling directly reduces environmental impact. Fewer paper leaflets mean less deforestation, lower CO₂ emissions, and no shipping of printed booklets. For example, a multinational that replaces 10 million leaflets annually with QR or 2D matrix codes can eliminate hundreds of tonnes of paper waste.

It also prevents overproduction and label destruction when info changes—allowing real-time updates without any reprinting. For companies under ESG scrutiny, e-labelling supports sustainability metrics and enhances green brand perception.

Greener pharma: how e-labelling and the shift toward what is electronic product information reduce waste

As global industries move toward sustainable practices, e-labelling stands out as a simple yet impactful solution. But to understand its role, it’s essential to ask: what is electronic product information in this context?

E-labelling or also so called electornic product information (digital access to regulated product labels), this approach eliminates the need for printed leaflets and oversized packaging.

Here’s how it supports environmental goals:

  • paper savings: A single pharmaceutical company can eliminate millions of printed leaflets per year by switching to ePI.
  • Carbon footprint reduction: No physical transport or storage is needed for electronic content.
  • Smaller packaging: Without paper inserts, packaging can be more compact and eco-efficient.
  • Instant updates: Information changes no longer require reprinting or repackaging—just a digital refresh.
  • Reduced material waste: Outdated or damaged stock is minimized, improving both sustainability and supply chain efficiency.

By answering the question “what is electronic product information?” in practical terms, we see that it’s not just a regulatory tool—it’s an enabler of green innovation. Combined with e-labelling, it transforms product communication into a low-impact, digitally native process that meets both compliance and climate targets.

The bottom line: sustainability and regulatory excellence are no longer in conflict—they’re now digitally aligned.

What are the key challenges in implementing electronic product information?

Despite its advantages, moving to electronic product information poses technical and regulatory challenges:

  • integrating with legacy IT systems.
  • Ensuring 24/7 digital access with backup and redundancy.
  • Aligning with global regulatory frameworks like EMA’s ePI or FDA’s SPL.
  • Training internal teams to manage digital content workflows.
  • Addressing digital literacy in some patient groups.
  • Global initiatives and integration.

Yet these hurdles are surmountable with proper planning, phased rollout, and collaboration with ePI experts.

Why is e-labelling becoming a global standard for product communication?

The world is going digital—and regulators are catching up. The EMA, FDA, Health Canada, and others are moving toward mandatory or encouraged e-labelling systems. QR or 2D matrix code-based leaflets, XML-structured content, and multilingual web portals are becoming the norm.

Globalisation demands label adaptability for diverse markets. Digital labels are easier to translate, update, and distribute—improving speed to market and reducing compliance risk.

E-labelling isn’t just a trend; it’s the new global communication standard for regulated product information.

Read also:

Sources: 1 – European Medicines Agency (EMA). Electronic Product Information (ePI)., 2 – Regulatory Science NL. Electronic Product Information: A Paradigm Shift for Better Use., 3 – Health Policy Partnership. Securing the Future for Accessible Delivery of Medicine Information Through Digitalisation., 4 – Advanco. The Transition to Paperless E-labelling in Pharma Packaging., 5 – Freyr Solutions. e-Labelling in Pharma: Simplifying Compliance and Enhancing Efficiency., 6 – Schlafender Hase. Maximizing the Benefits of E-labelling in Pharma and Medtech., 7 – EFPIA. Position Paper on Phasing In ePI and Phasing Out Paper Leaflets., 8 – Pharmaceutical Executive. e-Labelling: Change Underway.

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