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Why Docuvera

Structured Content for ePI

Why ePI Changes Everything

The transition from static, document-based product information to electronic Product Information (ePI) is more than a formatting upgrade—it’s a shift in how patients, healthcare professionals, and regulators access and interact with medicinal information.

Led by the European Medicines Agency (EMA) and supported by regulatory agencies globally, the ePI initiative requires that product information be:

Digitally accessible
Machine-readable
Easy to update and disseminate across platforms

Traditional labeling systems—reliant on manual updates to static PDFs or word-processed files—cannot meet these demands at scale. Structured content authoring is now essential to ePI compliance, speed, and reliability

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How Docuvera Enables ePI Readiness

Single Source for Leaflets and SmPCs

Docuvera enables pharma companies to create patient leaflets, SmPCs, and CCDS from a single, structured content repository. Each content component is reusable, version-controlled, and metadata-tagged—ensuring that updates flow consistently across outputs.

Metadata for Localization and Channel Control

Structured metadata within Docuvera allows organizations to tag content by market, language, and output format. This enables the automated generation of localized documents that align with ePI expectations—without risking manual errors or misalignment between versions.

Synchronized, Multichannel Updates

Whether delivering updates to regulators via structured submission formats or pushing information to patient-facing portals and digital leaflets, Docuvera ensures that changes propagate instantly across all platforms. Teams no longer have to track version histories manually across SmPC, USPI, and ePI systems.

Improved Communication with Patients and HCPs

ePI is not just about technical compliance—it’s about improving healthcare communication. With structured content, pharma companies can deliver patient-specific, accessible information that aligns with regulatory requirements and supports shared decision-making.

Docuvera enables faster, clearer, and more consistent delivery of medical content to the people who need it most.

From Static Documents to Dynamic Product Information

ePI marks a turning point for pharmaceutical labeling: one where content is no longer locked inside PDFs but dynamically delivered across channels and jurisdictions.

Structured content is the only viable way to keep pace with:

Increasing frequency of regulatory updates
Requirements for multilingual, localized content
Expectations for real-time synchronization between regulatory and patient-facing systems

Docuvera provides the foundation to meet these challenges—with confidence and control.

Related COntent:

Digital Transformation in Pharma
The Importance of SCA for ePI Compliance
Summary of Product Characteristics (SmPC)

Docuvera is here to help you succeed—compliantly, efficiently, and confidently.

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