Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use International flag

This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0: STU1) based on FHIR v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Use Case

FHIR ePI Documents

As noted in the background, ePIs take three forms:

  1. Information for healthcare professionals
  2. Information for patients
  3. Information on the package label

ePI documents are made up of the following five components:

  • Narrative - Section headings, paragraphs, bulleted lists, tables
  • Document data - Date of approval, date of last update, unique identifiers
  • Medicinal Product data - dosage form, strength, route of adminisation, ingredients, packaging
  • Organization data - Name, address, unique identifiers, and contact information
  • Clinical use data - Contraindication, indications, warnings and precautions

Overview of the FHIR Resources that make up the common ePI Profile

This Implementation Guide recommends the use of the following thirteen resources to support the creation and exchange of ePIs:

  • List
  • Bundle
  • Composition
  • Binary
  • Organization
  • Regulated Authorization
  • Medicinal Product Definition
  • Administrable Product Definition
  • Manufactured Item Definition
  • Ingredient
  • Substance Definition
  • Packaged Product Definition
  • Clinical Use Definition

It is not mandatory for any implementers to use all thirteen resources for all ePIs. Dependent on the region, or dependent on the use case, implementers may choose to use all or some of the thirteen resources. For example, health authorities are encouraged to use combinations of these resources to recreate their national ePI templates with these resources. Thus, allowing them to reap the benefits of FHIR while still maintaining compliance with local regulations and local ePI templates with regulated section and sub-section headings. Although optional, this IG recommends adopting one of the following three general approaches to encourage consistency.

  • Type 1 ePI documents support creating the narrative content (e.g., document type, document identifier, section headings, paragraphs, and tables) and only a basic list of medicinal products.
  • Type 2 ePI documents support creating the narrative content and now includes product information. However, it does not include structured clinical use information.
  • Type 3 ePI documents support creating the narrative, product information, and structured clinical use information.

Table 1 Overview of resources, ePI use cases for each resource, and ePI document types

FHIR Resource ePI use cases for each resource ePI Type 1 ePI Type 2 ePI Type 3
List List of related ePI documents; e.g., list of Summary of Product Characteristics (SmPC), Package Leaflet, package artwork/mockups, and Annexes for a given medicinal product. x x x
Bundle Container for a collection of resources and forms a FHIR document. x x x
Composition Basic structure and narrative content for a document (e.g., section headings, paragraphs, tablets, bulleted lists). x x x
Binary Encoded images. x x x
Organization Name, address, contact information, and idenifiers for referenced companies. x x x
Regulated Authorization Regulatory license for each medicinal product.   x x
Medicinal Product Definition Details for each regulated medicinal product   x x
Administrable Product Definition Final form of the medicinal product ready for administration to a patient   x x
Manufactured Item Definition Dose form of the medicinal product in its primary packaging   x x
Ingredient Ingredients (active, inactive, adjuvants) in which the manufactured item is composed of.   x x
Substance Definition Substances assocated with the ingredients.   x x
Packaged Product Definition Describes the unit for sale or supply (e.g., container closure system; primary and secondary packaging; items in the pack)   x x
Clinical Use Definition Structured information about indication, contraindication, interactions (drug:drug, drug:food; drug:lab); undesireable effect; warning     x