Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide, published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions
Contents:
This page provides a list of the FHIR artifacts defined as part of this implementation guide.
The following artifacts define the specific capabilities that different types of systems are expected to have in order to comply with this implementation guide. Systems conforming to this implementation guide are expected to declare conformance to one or more of the following capability statements.
| Advanced Vulcan ePI Server Capability Statement |
| Simple Vulcan ePI Server Capability Statement |
These define constraints on FHIR resources for systems conforming to this implementation guide.
| AdministrableProductDefinition (ePI) |
AdministrableProductDefinition (ePI) |
| Bundle - ePI |
Medicinal product information is a pivotal source of regulated and scientifically validated information that assists healthcare professionals in prescribing and dispensing the medicine and informs consumers about its safe and effective use. This profile represents the constraints applied to the Bundle resource used in the Electronic Product Information (ePI) FHIR Implementation Guide. |
| ClinicalUseDefinition Contraindication (ePI) |
ClinicalUseDefinition Contraindication (ePI) |
| ClinicalUseDefinition Indication (ePI) |
ClinicalUseDefinition Indication (ePI) |
| ClinicalUseDefinition Interaction (ePI) |
ClinicalUseDefinition Interaction (ePI) |
| ClinicalUseDefinition Undesirable Effect (ePI) |
ClinicalUseDefinition Undesirable Effect (ePI) |
| ClinicalUseDefinition Warning (ePI) |
ClinicalUseDefinition Warning (ePI) |
| Composition (ePI) |
The Composition captures the section headings, sub-section headings, and narrative text (For example, paragraphs, bulleted lists, tables) in an ePI. |
| Ingredient (ePI) |
Ingredient (ePI) |
| ManufacturedItemDefinition (ePI) |
ManufacturedItemDefinition (ePI) |
| MedicinalProductDefinition (ePI) |
Description of the packaged authorized medicinal product(s) associated to this ePI document. |
| Organization (ePI) |
Organization (ePI) |
| PackagedProductDefinition (ePI) |
PackagedProductDefinition (ePI) |
| RegulatedAuthorization (ePI) |
RegulatedAuthorization (ePI) |
| SubstanceDefinition (ePI) |
SubstanceDefinition (ePI) |
These define sets of codes used by systems conforming to this implementation guide.
| Administrable Pharmaceutical Dose Form |
Administrable Pharmaceutical Dose Form |
| Color of the product |
Color of the product |
| Dose Form |
The dose form for a single part product, or combined form of a multiple part product |
| Flavor of the product |
Flavor of the product |
| ISO Country two letter code |
ISO Country two letter code |
| ISO language two letter code |
ISO language two letter code |
| Ingredient Role |
Ingredient Role; e.g.,active, excipient |
| Manufactured Dose Form |
Manufactured Dose Form |
| MedDRA Terms for clinical diseases and symptoms |
MedDRA Terms for clinical diseases and symptoms |
| Route Of Administration |
Route Of Administration |
| Section Codes |
Section Codes |
| Shape of the product |
Shape of the product |
| Substances |
Substances |
| Units of Presentation |
Units of Presentation |
| WHO ATC |
World Health Organization Anatomical Therapeutic Chemical (ATC) classification system |
| ePI document types |
ePI document types |
These define new code systems used by systems conforming to this implementation guide.
| eMedicinal Product Information Code System |
eMedicinal Product Information Code System. Coded concepts defined for ePI use only. |
These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.
| Administrable Product for DrugX 75 mg tablets |
DrugX 75 mg tablet |
| Clinical Use - Contraindication |
Contraindication example - Gastrointestinal disorders |
| Clinical Use - Indication |
Indication example - psoriasis |
| Clinical Use - Interaction |
Interaction example - methotrexate |
| Clinical Use - Undesirable Effect |
Undesirable Effect example - Psoriasis |
| Clinical Use - Warning |
Warning - hypotension |
| Ingredient - Carnauba wax |
Excipient ingredient using Carnauba wax |
| Ingredient - Croscarmellose sodium |
Excipient ingredient using Croscarmellose sodium |
| Ingredient - Hypromellose |
Excipient ingredient using Hypromellose |
| Ingredient - Lactose Monohydrate |
Excipient ingredient using Lactose Monohydrate |
| Ingredient - Macrogol 3000 |
Excipient ingredient using Macrogol 3000 |
| Ingredient - Magnesium stearate |
Excipient ingredient using Magnesium stearate |
| Ingredient - Microcrystalline cellulose |
Excipient ingredient using Microcrystalline cellulose |
| Ingredient - Silicon dioxide |
Excipient ingredient using Silicon dioxide |
| Ingredient - Titanium Dioxide |
Excipient ingredient using Titanium Dioxide |
| Ingredient - acetaminophen |
Active ingredient using acetaminophen |
| Manufactured Item - 75 mg tablet |
DrugX 75 mg tablet |
| Medicinal Product DrugX 75 tablet in a blister of x28 tablets |
Medicinal Product for DrugX 75 mg tablet blister x28 |
| Organization - Acme Inc. |
Marketing Authorization Holder |
| Package Leaflet with a medicinal product |
Example of a Package Leaflet with a reference to a medicinal product as its subject |
| Package Leaflet without a medicinal product |
Example of a Package Leaflet with no references to a medicinal product (i.e., no subject) |
| Packaging - Blister |
Blister x28 tablets |
| Regulated Authorization for the 75 mg tablet |
Regulated Authorization for the 75 mg tablet |
| Substance - acetaminophen |
Substance details for the active ingredient - acetaminophen |
| ePI Bundle Type 1 - DrugX Package Insert |
Example of a type 1 ePI Bundle - Package Insert |
| ePI Bundle Type 2 - DrugX Package Insert |
Example of a type 2 ePI Bundle - Package Insert |
| ePI Bundle Type 3 - DrugX Package Insert |
Example of a type 3 ePI Bundle - Package Insert |
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group. Package hl7.fhir.uv.emedicinal-product-info#1.0.0 based on FHIR 5.0.0. Generated 2024-07-15
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