CH EPL (R5)
1.0.1 - trial-use Switzerland flag

CH EPL (R5), published by Federal Office of Public Health FOPH. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/bag-epl/bag-epl-fhir/ and changes regularly. See the Directory of published versions

IDMP and FHIR

HL7 FHIR IDMP Overview

The International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards define a set of rules and data elements for uniquely identifying medicinal products globally. HL7 FHIR provides a set of resources and profiles that implement the IDMP standard, enabling consistent representation, exchange, and regulatory reporting of medicinal product information.

Core IDMP Resources in FHIR

MedicinalProduct - IDMP Medicinal Product

Captures high-level information about a medicinal product, including its name, type, status, and active ingredients. This resource supports global identification of the product independent of packaging or marketing authorization. FHIR Medicinal Product Definition

MedicinalProductAuthorization - IDMP Marketing Authorisation

Represents the regulatory approval status of a medicinal product, including marketing authorization holder, authorized countries, dates, and regulatory conditions. FHIR Regulated Authorization

PackagedMedicinalProduct - IDMP Packaged Medicinal Product

Captures packaging information for a medicinal product, including container types, pack sizes, materials, and identifiers (e.g., GTINs). This allows precise tracking and identification of marketed products. FHIR Packaged Product Definition

AdministrableProduct - IDMP Pharmaceutical Product

Describes the pharmaceutical form, route of administration, and packaging for the product, providing precise details for safe administration to patients. FHIR Administrable Product Definition

MedicinalProductIngredient - IDMP Ingredient

Defines individual ingredients within a medicinal product, specifying their role (active vs. excipient), strength, and relationship to the overall product. FHIR Ingredient

ManufacturedItem - IDMP Manufactured Item

Represents a manufactured batch or item of a medicinal product. This resource contains detailed manufacturing information, including manufacturer, site, batch identifiers, and production attributes. FHIR Manufactured Item Definition

ClinicalUseDefinition - IDMP Clinical Particulars

Captures information on the clinical use of a medicinal product, such as indications, contraindications, warnings, adverse effects, and dosage guidelines. This resource is critical for patient safety, pharmacovigilance, and clinical decision support. FHIR Clinical Use Definition

Substance - IDMP Substance

Represents the chemical or biological substance that forms the active ingredient or excipient of a medicinal product. Substances are identified with unique identifiers and may include structural, compositional, and functional information. FHIR Substance Definition

Terminology and Coding

IDMP FHIR resources rely heavily on standardized terminologies to ensure semantic interoperability:

  • ISO IDMP codes for substances, units, routes of administration, and dosage forms
  • ATC (Anatomical Therapeutic Chemical Classification System) for pharmacological classification
  • UN/GS1 identifiers for organizations, locations, and packaging
  • National coding systems for regulatory identifiers (e.g., Swissmedic, EMA LOC/RMS IDs)

Implementation in FHIR

  • FHIR IDMP profiles provide structured, machine-readable representations of medicinal product data.
  • These profiles facilitate regulatory reporting, pharmacovigilance, clinical research, and cross-border exchange.
  • Implementation Guides define constraints, mandatory fields, and terminology bindings to ensure consistent adoption across jurisdictions.

Adoption and Use Cases

  • National regulatory agencies and pharmaceutical companies use IDMP FHIR resources to standardize medicinal product information for regulatory submissions.
  • Cross-border initiatives in the EU (e.g., EMA SPOR, RMS, OMS) rely on FHIR IDMP resources for interoperability and harmonization.
  • Integration with electronic health records, clinical decision support, and supply chain management ensures accurate identification of products at the point of care.

For more information, see the official HL7 FHIR IDMP resources:
https://hl7.org/fhir/idmp.html