German (DEU) Electronic Product Information (ePI) Product Leaflet (PL) Implementation Guide
0.1.0 - ci-build
German (DEU) Electronic Product Information (ePI) Product Leaflet (PL) Implementation Guide - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Official URL: http://pharmaprotect.de/digital/epil-fhir-ig/ImplementationGuide/DEUePIPL | Version: 0.1.0 | |||
| Draft as of 2025-06-13 | Computable Name: DEUePiPlImplementationGuide | |||
The aim of this implementation guide is to enable the exchange of structured electronic product information leaflets (ePIL) based on a common collection and understanding of corresponding content and all related data. For this data the HL7 standards and terminologies are used and incorporated into a meaningful and appropriate resource setup.
This ePIL guide shall be established as a standard for requesting the right ePIL for a given product to ensure a direct reference to the right and approved patient information. So the selection of resources enables to allocate, forward, and find a specific ePIL between connected services and systems based on any own data model connected to the ePIL. With that it is possible to manage and offer ePIL content for a patient regardless the specific used search term such as e.g. ePIL name (parts), product name, GTIN, batch number, national identifier, responsible MAH etc.
Define a common and interoperable standard for exchanging medicinal product information leaflets across international systems, services and other valid entities such as public sector or authorities including all context data of an ePIL.
The ePIL, electronic Product Information leaflet or short Information for Patients, is a part of the full ePI, a medicine’’s product information which also contains information for health care professionals and package label information. In different contexts and countries the ePIL may also have different names. The ePIL content is based on the QRD template and constraints concerning the order, amount, and names of paragraphs. In Europe it is also a mandatory extra printed part of the package handed out to the patient and thus the ePIL’s physical and digital format very often is related to a printable PDF format. This unstructured format and the underlying preparation of texts for a print are not optimal for digital representations on smartphones, tablets, and other small screens with limited sizes but mighty reading support functions (search, adaptive designs, and readability help such as paragraph collapsing). Also the patients perspective needs to be incorporated to not just handing over a fixed set of paragraphs for a product that is maybe only close to the exact package he is looking for. Since products and their packs sometimes are very close to eachother, especially their versions and an unambiguous relation between specific pack and its valid leaflet is missing in the digital representation: a system must be able to find the specific leaflet based on product scan (identifier) but also based on fuzzy search terms like product name, (parts of) MAH name, ePIL title, parts of content, and other related ePIL context data. To solve this HL7 FHIR format adopts the corresponding text and further data fields in a standardized and exchangeable way. This ensures to collect all necessary and right ressources connected to the patients use cases and enables further 3rd party systems such as compendia data management and adapted output generation which reflect the patients needs and minimize wrong ePIl presentations such as an outdated version.
Download the Implementation Guide Package (package.tgz)