German (DEU) electronic Product Information Leaflet (ePIL) Implementation Guide
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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
| Official URL: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/ImplementationGuide/DEU-ePIL | Version: 0.7.0 | |||
| Draft as of 2026-05-04 | Computable Name: DEU_ePIl_ImplementationGuide | |||
Important: eAAPI (Input) and eCAPI (Output) Use Different Profiles
This IG defines two sets of FHIR profiles for different purposes:
- eAAPI profiles are used to submit ePIL content to the central platform. They enforce all mandatory data fields required for a complete, validated submission.
- eCAPI profiles are used to deliver ePIL content to patient-facing systems. They are derived from the eAAPI profiles and share the same data field formats and meanings — but relax certain mandatory fields to optional, since not all submission details are relevant for consumer display.
Both profile sets are documented separately throughout this IG. See Composition Sections for a detailed comparison.
Terminology Note: ePIL vs. ePI PL
Throughout this Implementation Guide, we use the term ePIL (electronic Product Information Leaflet) to refer to the patient-facing electronic leaflet. This is equivalent to the EMA terminology ePI PL (electronic Product Information Package Leaflet), which describes the same concept. Both terms refer to the digital version of the patient information leaflet that accompanies medicinal products.
The choice of "ePIL" in this guide is for consistency and readability, while maintaining full compatibility with EMA regulatory frameworks that use "ePI PL".
German ePIL Pilot Project
Based on the current EU regulatory roadmap, the use of electronic product information (ePI) is anticipated to become mandatory across member states, although no binding timeline has been established yet.
In Germany, the diGItal Pilot Project was launched to proactively explore and test practical scenarios for the implementation and use of electronic product information leaflets. In doing so, the project provides real-world insights to support the regulatory discourse at both the European and national levels.
As part of this initiative, a centralized system is being developed that will serve as a trusted source for all ePILs (electronic Product Information Leaflets) in Germany. Pharmaceutical companies will populate this system with their respective ePILs. Authorized stakeholders with a legitimate interest will be able to access the data via standardized interfaces.
The use cases to be tested include:
The Role and Structure of the ePIL
The ePIL (electronic Product Information Leaflet) is a subset of the broader electronic Product Information (ePI). While the ePI includes content for healthcare professionals and package labeling information, the ePIL focuses specifically on the patient-facing part. ePILs in Europe follow the QRD (Quality Review of Documents) template, which imposes constraints on structure, order, and coding of the sections.
The Role of HL7 FHIR
To address these requirements, the HL7 FHIR standard is used. It provides a structured, exchangeable data format for representing both the textual and contextual content of the ePIL. This enables:
In sum, the diGItal project is laying the groundwork for a future-proof, interoperable, and patient-focused ePIL infrastructure, aligning national implementation with European regulatory developments.
This Implementation Guide (IG) defines the FHIR-based data standard for two complementary interfaces of the German national ePI pilot platform:
1. eAAPI — electronic Author API (Input) The eAAPI is the submission interface through which marketing authorization holders provide structured ePIL content to the central pilot platform. The input profile defined in this IG specifies all mandatory and optional data fields required for a complete, validated ePIL submission — including product metadata, packaging identifiers, and the full QRD-compliant composition structure.
2. eCAPI — electronic Consumer API (Output) The eCAPI is the retrieval interface through which authorized external systems (e.g., health insurance apps, pharmacy systems, public health portals) access published ePIL content. The output profile is derived from the input profile and shares the same data field formats and semantics, but relaxes certain mandatory constraints — reflecting that not all submission metadata is relevant or appropriate for consumer-facing delivery.
Note: The output (eCAPI) profile is a proper subset of the input (eAAPI) profile. Any valid output instance is structurally compatible with the input profile, but the reverse is not necessarily true due to additional mandatory fields in the input profile.
By leveraging HL7 FHIR standards and controlled terminologies, the IG provides a consistent and interoperable approach to managing ePILs across diverse IT landscapes. This supports enhanced data accessibility, version control, and targeted information delivery based on regulatory, clinical, and patient-centered needs.
The IG defines a standardized resource structure for representing ePILs, including relationships to product identifiers. The ePILs are represented as FHIR-compliant resources, including:
In Scope
Out of Scope
This German pilot IG builds on and aligns with broader ePI efforts, including:
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