http://ema.europa.eu/fhir/CodeSystem/100000000009
http://ema.europa.eu/fhir/CodeSystem/100000155531
http://ema.europa.eu/fhir/CodeSystem/200000000006
http://ema.europa.eu/fhir/CodeSystem/200000029659
http://fhir.de/CodeSystem/ifa/pzn
http://snomed.info/sct
http://www.whocc.no/atc
https://bivalidation.docuvera.com
https://iris.ema.europa.eu/substances/
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This publication includes IP covered under the following statements.
Type | Reference | Content |
---|---|---|
web | epi-dev.ema.europa.eu | EMA IG |
web | www.pharmaprotect.de |
IG © 2025+ ACS PharmaProtect GmbH
. Package DEUePIPL#0.1.0 based on FHIR 5.0.0
. Generated 2025-06-13
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 | 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 German context and the digital pilot use case. |
web | spor.ema.europa.eu | This document outlines the hierarchical section structure of the PACKAGE LEAFLET in alignment with SPOR codes . It includes all known headings, nested subsections, and indication of optional segments. |
web | ema.europa.eu | EUEpiCompositionCAP |
web | ema.europa.eu | EUQRD-CAP-template-new-Package-Leaflet-de |
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.
|
FHIR_Organisation.png ![]() |
tree-filter.png ![]() |