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EMA’s Reflection Paper: Linking to ePI from EU Medicine Packages – A Digital Leap in Patient Information

The European Medicines Agency (EMA) published on 31 March 2025 a draft "Reflection paper on linking to electronic Product Information (ePI) from EU Medicine Packages" that explores innovative ways to digitally connect patients and healthcare professionals (HCPs) to electronic product information (ePI) directly from medicine packaging. This initiative is part of EMA’s broader vision for digital transformation in the life sciences sector, aiming to improve access to accurate, up-to-date medicine information in a secure, inclusive, and user-friendly way.


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. Electronic product information (ePI), generated as an outcome of EU regulatory procedures, is under development by the European Medicines Regulatory Network (EMRN).


The EMA proposes using the existing DataMatrix code on medicine packaging as a gateway to electronic product information (ePI). This approach aims to simplify access to critical safety and usage details, such as package leaflets and summaries of product characteristics (SmPC), through mobile scanning technology. By utilizing the DataMatrix already printed for anti-counterfeiting purposes, the solution avoids adding extra codes that could confuse users or clutter packaging.


The initiative prioritizes patient-friendly solutions, focusing on accessibility, usability, and inclusivity for individuals with varying levels of digital literacy. The ultimate goal is to ensure equal access to ePI across Europe, supporting informed healthcare decisions and improving patient safety.


Components of an ePI Access Solution

1. 2D Code (DataMatrix)

The DataMatrix code is currently printed on EU prescription medicine packaging as part of anti-counterfeiting measures under the Falsified Medicines Directive. It contains essential data like:

  • Product identifier (e.g., GTIN/NTIN/PPN)

  • Serial number

  • Expiry date

  • Batch number

The EMA suggests leveraging this existing code to link directly to ePI without requiring additional codes, ensuring simplicity and consistency across all EU medicines.

2. Scanning and Linking Technology

A solution for accessing ePI must include:

  • DataMatrix scanning capability: While most smartphones cannot natively scan DataMatrix codes, apps or software can bridge this gap until camera technology evolves further.

  • ISO-compliant resolver: This system matches the scanned product identifier with the correct regulator-authorized ePI, ensuring minimal user effort.

To maximize accessibility, web-based solutions are preferred over downloadable apps, which may pose barriers for users with limited digital skills or device storage.

3. Displayed Content

The package leaflet is prioritized as the primary content displayed after scanning, providing patients with essential safety and usage information. Additional options may include:

  • Summary of Product Characteristics (SmPC) for healthcare professionals

  • Educational materials and instructional videos

  • Side-effect reporting tools

  • Alerts for expired medicines based on expiry date data in the DataMatrix

Barriers like login screens or excessive navigation steps should be avoided to ensure seamless access.

4. Governance

Cross-stakeholder collaboration is critical for developing and maintaining an EU-wide system that integrates ePI access into existing regulatory frameworks. This includes compliance with data protection laws like the General Data Protection Regulation (GDPR) when handling personal data during scanning or app use.


Opportunities

  • EU-wide coverage: A harmonized system ensures equal access to ePI for all EU citizens, including travelers and those affected by medicine shortages due to stock reallocation.

  • Improved patient safety: Up-to-date information supports informed decisions by patients and healthcare professionals alike.

Limitations

  • Digital literacy challenges: Solutions must cater to users with varying levels of familiarity with mobile technologies.

  • Technical barriers: Current smartphone cameras may require additional apps or software for DataMatrix scanning.

Other Considerations

  • Over-the-counter medicines may require tailored approaches due to broader consumer demographics.

  • Parallel trade medicines must address cross-border regulatory differences in packaging and labeling requirements.

  • Printed package leaflets will remain essential for individuals without access to digital tools.


Real-World Examples

Several countries have implemented similar systems that provide valuable insights into potential EU-wide adoption:

Country

Key Features

Japan

QR codes link directly to electronic package leaflets in multiple languages.

Spain

Mobile apps enable scanning of medicine packaging for instant access to ePI.

Germany

Pharmacy Product Numbers (PPN) integrate seamlessly into existing systems.

Nordic Countries

Collaboration across borders ensures consistent access to digital medicine information.

Ukraine Initiative in Poland

Leveraged QR codes during wartime shortages to provide critical medicine details.

The EMA's reflection paper highlights the transformative potential of linking electronic product information (ePI) from EU medicine packages using existing DataMatrix codes. By prioritizing accessibility, inclusivity, and patient safety, this initiative can modernize how essential medicine information is delivered across Europe while reducing logistical hurdles for consumers and healthcare providers alike.


Stakeholders are encouraged to collaborate on developing a harmonized system that meets these goals while addressing technical and regulatory challenges. Public consultation on this draft paper is open until 30 June 2025, inviting feedback from industry experts, patients, and healthcare professionals alike.


You can send your feedback to this public consultation via the form available below:


For full details, click this LINK.





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