IP Review

Unattributed Code Systems

Copyright Fragment

This fragment is not visible to the reader

No use of external IP (other than from the FHIR specification)

Copyright and Registered Trademark Uses

IG © 2025+ ACS PharmaProtect GmbH. Package DEU-ePIL#0.7.0 based on FHIR 5.0.0. Generated 2026-05-04 Links: Table of Contents | QA Report ( src )
hl7.fhir.us.hai: Healthcare Associated Infection Implementation Guide ®© HL7 | CC0 ( src )
German (DEU) electronic Product Information Leaflet (ePIL) Implementation Guide - Local Development build (v0.7.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions ( src )

External References

Type Reference Content

Type	Reference	Content
web	epi-dev.ema.europa.eu	EMA IG
web	www.pharmaprotect.de	IG © 2025+ ACS PharmaProtect GmbH . Package DEU-ePIL#0.7.0 based on FHIR 5.0.0 . Generated 2026-05-04 Links: Table of Contents \| QA Report
web	en.wikipedia.org	Both Bundle.link and Bundle.entry.link are defined to support providing additional context when Bundles are used (e.g. HATEOAS ).
web	epi-dev.ema.europa.eu	EMA SPOR Codes - Standard EMA section codes
web	epi-dev.ema.europa.eu	This resource model is designed to ensure traceability and structure throughout the ePI lifecycle, while maintaining alignment with regulatory requirements and the HL7 FHIR standard. It leverages base resources and patterns from the Vulcan ( Vulcan ePI IG ) and EMA ( EMA ePI IG ) implementation guides, but further details and adapts them for the specific requirements of the diGItal project context and digital pilot use case.
web	epi-dev.ema.europa.eu	To include images (such as pictograms or logos) in the package leaflet, use the epi-image-reference extension . Images must be added as contained `Binary` resources within the Bundle. Reference these images in the appropriate section(s) of the Composition using the `epi-image-reference` extension, which links to the contained Binary. This approach enables images to be rendered in the correct context within the electronic leaflet.
web	epi-dev.ema.europa.eu	The QRD root section contains all regulatory content aligned with the EMA QRD template. It includes EMA chapters 1-6 with their subsections (using SPOR codes ), plus approved additional chapters specific to QRD Rev. 11.
web	epi-dev.ema.europa.eu	EMA Chapters 1-6: Use standard SPOR codes — see QRD 10.4 and QRD 11 for details
web	spor.ema.europa.eu	This document outlines the hierarchical section structure of the Package Leaflet based on QRD Template Revision 10.4 in alignment with SPOR codes .

web

epi-dev.ema.europa.eu

EMA IG

web www.pharmaprotect.de IG © 2025+ ACS PharmaProtect GmbH . Package DEU-ePIL#0.7.0 based on FHIR 5.0.0 . Generated 2026-05-04
Links: Table of Contents | QA Report

web en.wikipedia.org Both Bundle.link and Bundle.entry.link are defined to support providing additional context when Bundles are used (e.g. HATEOAS ).

web epi-dev.ema.europa.eu EMA SPOR Codes - Standard EMA section codes

web epi-dev.ema.europa.eu This resource model is designed to ensure traceability and structure throughout the ePI lifecycle, while maintaining alignment with regulatory requirements and the HL7 FHIR standard. It leverages base resources and patterns from the Vulcan ( Vulcan ePI IG ) and EMA ( EMA ePI IG ) implementation guides, but further details and adapts them for the specific requirements of the diGItal project context and digital pilot use case.

web epi-dev.ema.europa.eu To include images (such as pictograms or logos) in the package leaflet, use the epi-image-reference extension . Images must be added as contained Binary resources within the Bundle. Reference these images in the appropriate section(s) of the Composition using the epi-image-reference extension, which links to the contained Binary. This approach enables images to be rendered in the correct context within the electronic leaflet.

web epi-dev.ema.europa.eu The QRD root section contains all regulatory content aligned with the EMA QRD template. It includes EMA chapters 1-6 with their subsections (using SPOR codes ), plus approved additional chapters specific to QRD Rev. 11.

web epi-dev.ema.europa.eu EMA Chapters 1-6: Use standard SPOR codes — see QRD 10.4 and QRD 11 for details

web spor.ema.europa.eu This document outlines the hierarchical section structure of the Package Leaflet based on QRD Template Revision 10.4 in alignment with SPOR codes .

Internal Images

FHIR_Organisation.png

tree-filter.png