This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR v5.0.0-ballot. . For a full list of available versions, see the Directory of published versions

Introduction

Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/ImplementationGuide/hl7.fhir.uv.emedicinal-product-info				Version: 1.0.0-ballot
Active as of 2022-12-04				Computable Name: EpiIG

Purpose

To provide guidance on the technical and business conformance rules needed to create and exchange electronic Product Information (ePI) using FHIR and standard terminologies; and, as well as to create a common global approach for structuring medicinal product information and medicinal product labelling that is based on HL7 International standards.

Goals

The immediate goal of this specification is to expose ePI consumers and the vendor community to a set of profiles that identify the data elements, code systems and value sets commonly used in ePIs regardless of the jurisdiction.

The strategic goal is to offer a better route for patients to access trustworthy, up-to-date medicinal product information that better meets their individual needs.

Objectives

Define a common and interoperable standard for exchanging medicinal product information across international healthcare jurisdictions.

Scope

In Scope

ePI (information for healthcare practitioner, information for the patient, package label). Human pharmaceutical, radiopharmaceutical and biologic medicinal products (prescription and physician-administered). Over the counter (non-prescription) drugs Investigational and authorized medicinal products Medical devices co-packed with a biopharmaceutical product (e.g., pre-filled syringe). FHIR resources: List Bundle Composition Organization Regulated Authorization Medicinal Product Definition Administrable Product Definition Manufactured Item Definition Ingredient Substance Definition Packaged Product Definition Clinical Use Definition Binary

Out of Scope

Self-care products, natural health products, medical devices, food and veterinary drugs.

How to use this guide

The Core ePI Implementation Guide is a common baseline from which other FHIR ePI implementation guides can be derived. It is not expected to be implemented as is. It is meant to be a common starting point to build region specific profiles that support local requirements and local use cases.

For example, the content of this implementation guide can be used to develop FHIR ePI profiles for the USA, European Union, and Japan that are interoperable and can be supported by the same vendor marketplace.

Establishing a consistent set of rules across jurisdictions promotes interoperability; allows flexibility for standard evolution; and creates a uniform landscape for vendors to create solutions and services.

Core ePI Profile

The Core ePI Profile defines the minimum set of rules to create a compliant FHIR ePI. National ePI profiles are expected to comply with the Core ePI Profile.

National ePI Profiles

National profiles define the minimum mandatory elements, extensions and terminology requirements to create a compliant FHIR ePI for a given jurisdiction.

Conformance to a national ePI profiles is tied to the regulatory mandates of the health authority for that jurisdiction.

Status

This implementation guide is based on FHIR v5.0.0-snapshot1: R5 Snapshot #1 and is intended to be a balloted draft standard for trial use. It is subject to a formal review and approval process.

This guide is a living document that includes instructions and profiles that will evolve as it undergoes review by the FHIR community and through testing feedback.

Additional changes by HL7 are expected because FHIR is an evolving standard. Developments will be assessed for impact; updates will be planned and communicated publicly in advance to allow time for a stakeholders to adapt to the new version.

Governance

The Core FHIR ePI Profile was defined by representatives from Gravitate Health, HL7’s Vulcan Accelerator, the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the Pharmaceuticals and Medical Devices Agency (PMDA).

The national FHIR ePI profiles were defined by representatives from the health authority for the corresponding jurisdiction, representatives from Gravitate Health, and HL7’s Vulcan Accelerator. On behalf of the international community and health authorities, this guide is maintained by HL7’s Biomedical Research and Regulation (BR&R) Working Group.

This guide will be reviewed annually for active use, obsolescence, and potential need for change. When a change is identified, HL7’s BR&R will make efforts to communicate to stakeholders or potential users in advance of any action.

Authors and Contributors

Role	Name	Organization
Co-Lead	Craig Anderson	Pfizer
Co-Lead	Catherine Chronaki	HL7 Europe
Technical Lead	Jens Kristian Villadsen	Trifork
Technical Leads	Giorgio Cangioli	HL7 Europe
Gravitate Health Contributors
HL7 Vulcan Contributors