ePI Style guide available
The ePI Style guide, available in the PLM portal along with the QRD stylesheet and an xslt, provides applicants with clear instructions on how to include styling information in ePI. This resource helps ensure that electronic Product Information (ePI) is created in a way that is both regulator-compliant and optimised for digital use.
date: 22/09/2025
Styling refers to the way content can be displayed in a document, a webpage, or other user interface. For ePI, styling is important for compliance with regulatory requirements (e.g. QRD template and conventions), to convey the correct meaning and to optimise the user experience.
The ePI Style guide, available in the PLM portal along with the QRD stylesheet and an xslt, provides applicants with clear instructions on how to include styling information in ePI. This resource helps ensure that electronic Product Information (ePI) is created in a way that is both regulator-compliant and optimised for digital use.
The guide provides clear instructions on:
This initiative supports the broader goal of harmonising ePI across the EU, improving patient access to reliable product information, and enabling interoperability across regulatory and healthcare systems.
The ePI Style guide, available in the PLM portal along with the QRD stylesheet and an xslt, provides applicants with clear instructions on how to include styling information in ePI. This resource helps ensure that electronic Product Information (ePI) is created in a way that is both regulator-compliant and optimised for digital use.
The guide provides clear instructions on:
- How to apply styling when creating ePI via the PLM portal editor or importing FHIR files
- How QRD styles are automatically applied through the stylesheet
- How styling integrates into ePI components such as preview, export, and API
- Preview and export ePI with QRD styling applied
- Convert FHIR XML into styled HTML for local testing and quality checks
- Ensure styling is applied only where required, improving data quality and consistency
This initiative supports the broader goal of harmonising ePI across the EU, improving patient access to reliable product information, and enabling interoperability across regulatory and healthcare systems.