German (DEU) electronic Product Information Leaflet (ePIL) Implementation Guide
0.7.0 - ci-build
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
Contents:
This page provides a list of the FHIR artifacts defined as part of this implementation guide.
These are profiles on resources or data types that describe patterns used by other profiles, but cannot be instantiated directly. I.e. instances can conform to profiles based on these abstract profiles but do not declare conformance to the abstract profiles themselves.
| 05 - DEU ePIL Composition (Product Information Leaflet) |
Abstract base profile for Product Information Leaflet (PIL) documents. Defines the two root sections (QRD + Localized Sections), MAH extension, and shared metadata. Cannot be used directly — use eAAPI or eCAPI child profiles. |
| 05b - DEU ePIL Composition eCAPI (Output) |
Abstract output profile for ePIL retrieval via the eCAPI (electronic Consumer API). Includes change detection with section-level change marking and relatesTo version tracking. Section depth is determined by the concrete QRD profile. |
These define constraints on FHIR resources for systems conforming to this implementation guide.
| 01 - DEU ePIL Bundle |
This profile defines constraints on the EUEpiBundle to ensure a unique identifier across all Implementation Guides (GIs). All new versions of a GI must retain the same Bundle ID. |
| 02 - DEU ePIL Organization |
Defines the Organization resource for the Author or Marketing Authorization Holder (MAH) including identifier, name, and contact information. A Bundle contains 1 or 2 Organization resources: the Author (referenced in Composition.author) and optionally a separate MAH (referenced via the DEU-ePIL-MAH-Organization extension). |
| 03 - DEU ePIL Medicinal Product Definition |
Defines the MedicinalProductDefinition resource, including the product name, active ingredients, classification, and dose form, based on the specified SPOR coding system. |
| 04 - DEU ePIL Packaged Product Definition |
Defines the PackagedProductDefinition resource, including optional packaging identifiers (GTIN, NTIN, PPN, PZN, PCID), name, and quantity of contained items. |
| 06a - DEU ePIL QRD 10.4 Template eAAPI (German, Input) |
Concrete input profile for QRD Template Revision 10.4 via eAAPI. Enforces EMA chapters 1-6 with 3-level section depth, plus ACS extensions for instructions-for-use and information-for-hcp. No change detection. |
| 06b - DEU ePIL QRD 10.4 Template eCAPI (German, Output) |
Concrete output profile for QRD Template Revision 10.4 via eCAPI. EMA chapters 1-6 with 2-3 level section depth, plus ACS extensions for instructions-for-use and information-for-hcp. Includes change detection. |
| 06c - DEU ePIL QRD 11 Template eAAPI (German, Input) |
Concrete input profile for QRD Template Revision 11 (Draft) via eAAPI. QRD 11 structural changes vs 10.4: food/drink moved from chapter 2 to 3, revision date/other sources/HCP info removed from chapter 6. Enforces 3-level section depth. No change detection. |
| 06d - DEU ePIL QRD 11 Template eCAPI (German, Output) |
Concrete output profile for QRD Template Revision 11 (Draft) via eCAPI. QRD 11 structural changes vs 10.4: food/drink moved from chapter 2 to 3, revision date/other sources/HCP info removed from chapter 6. Allows 2-3 level section depth. Includes change detection. |
| INTERNAL - DEU ePIL QRD 10.4 Template eAAPI ginext |
INTERNAL — Not for public use. Concrete input profile for QRD 10.4 via eAAPI ginext for a specific client. Depth 2 only (no subsections). No change detection. |
| INTERNAL - DEU ePIL QRD 11 Template eAAPI ginext |
INTERNAL — Not for public use. Concrete input profile for QRD 11 (Draft) via eAAPI ginext for a specific client. Depth 2 only (no subsections). No change detection. |
These define constraints on FHIR data types for systems conforming to this implementation guide.
| DEU ePI Device Image Extension |
Extension to provide a device image (e.g., package, inhaler, pen, injection device) as a base64-encoded image. The image is displayed as a header above the root chapter and has no direct reference to the content. Used for visual representation of the product or administration device. |
| DEU ePI Organization Logo Extension |
Extension to provide the organization's logo as a base64-encoded image. This allows the logo to be embedded directly in the Organization resource for display in digital product information leaflets. |
| DEU ePI Section Change Extension |
Extension to mark sections (chapters) that have been changed in this version of the document. Used in conjunction with Composition.relatesTo to reference previous versions and indicate which specific sections have modifications. Applicable to sections at any nesting level (Level 1, Level 2, or Level 3). |
| MAH Organization Reference |
Reference to the Marketing Authorisation Holder (MAH) Organization. Mandatory on the Composition to identify the MAH, which may differ from the Author referenced in Composition.author. |
These define sets of codes used by systems conforming to this implementation guide.
| DEU ePIL Identifier Type ValueSet |
Extends the FHIR core Identifier Type ValueSet with the DEU ePIL package identifier type codes (GTIN, NTIN, PPN, PZN, PCID). |
These define new code systems used by systems conforming to this implementation guide.
| DEU ePIL Package Identifier Type |
Identifier type codes for package identifiers (GTIN, NTIN, PPN, PZN, PCID). GTIN/NTIN/PPN mirror EMA SPOR list 100000000009 (SPOR code values preserved). PZN and PCID are local codes — no SPOR entry exists. |
| Project specific Product Information Leaflet Section Code System |
Extensible section codes for diGItal Product Information Leaflet documents, organized by root section (QRD and Localized Sections). |