Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot
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 
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.
| epi-server |
This section describes a minumum expected capabilities of an ePI FHIR Server which is responsible for providing responses to the queries submitted by the ePI clients. Please refer to the XML or JSON versions of this specification for details on which elements search is to be enabled on. A compliant server SHALL adhere to the requirements listed in this resource, and implement the RESTful behavior according to the FHIR specification. |
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.
| Additional Monitoring Indicator |
Additional Monitoring Indicator |
| AdministrableProductDefinition identifier systems |
AdministrableProductDefinition Identifier systems (uri) |
| WHO ATC |
World Health Organization Anatomical Therapeutic Chemical (ATC) classification system |
| Authorization Status |
Authorization Status |
| Case System Identifiers |
Case System Identifiers |
| ISO Country two letter code |
ISO Country two letter code |
| Data Carrier Identifiers |
Listing of identifiers for Data Carriers |
| ePI document types |
ePI document types |
| The topic of this list |
The topic of this list |
| General Status used across ePI resources |
General Status used across ePI resources |
| Legal Status for the Supply |
Legal Status for the Supply |
| ManufacturedItemDefinition identifier systems |
ManufacturedItemDefinition Identifier systems (uri) |
| Marketing Status |
Marketing Status |
| MedicinalProductDefinition identifier systems |
MedicinalProductDefinition Identifier systems (uri) |
| Medicinal Product Type |
Medicinal Product Type |
| MedDRA Terms for clinical diseases and symptoms |
MedDRA Terms for clinical diseases and symptoms |
| Non-proprietary Name of the active ingredient(s) |
Non-proprietary Name of the active ingredient(s) |
| Type of operation |
Type of operation |
| Organization identifier systems |
Organization Identifier systems (uri) |
| Type of organization |
Type of organization |
| Package Material |
Package Material |
| High level Pack Type |
High level type of pack; e.g., medicinal product pack, sample pack, shipping container. |
| PackagedProductDefinition identifier systems |
PackagedProductDefinition Identifier systems (uri) |
| Part Type |
Part Type |
| Pediatric Use Indicator |
Pediatric Use Indicator |
| Combined Pharmaceutical Dose Form |
Combined Pharmaceutical Dose Form |
| Pharmaceutical Dose Form of the medicinal product |
Pharmaceutical Dose Form of the medicinal product |
| Product Confidentiality |
Product Confidentiality |
| Product Name Part Type |
Product Name Part Type |
| Color of the product |
Color of the product |
| Flavor of the product |
Flavor of the product |
| Score on the product |
Score on the product |
| Shape of the product |
Shape of the product |
| Surface form of the product |
Surface form of the product |
| Proprietary Name of the medicinal product |
Proprietary Name of the medicinal product |
| Type of Regulated Authorization |
Type of Regulated Authorization |
| Regulated Authorization Type identifier systems |
Regulated Authorization Type Identifier systems (uri) |
| Regulatory Activity Type |
Regulatory Activity Type; e.g., MAA |
| Ingredient Role; e.g., inactive, active base, active moiety |
Ingredient Role; e.g., inactive, active base, active moiety |
| Route Of Administration |
Route Of Administration |
| Pack Type |
Pack Type |
| Section Codes |
Section Codes |
| Shelf Life Type |
Shelf Life Type |
| Special Precautions For Storage |
Special Precautions For Storage |
| Strength of the medicinal product name |
Strength of the medicinal product name |
| Substances |
Substances |
| Units of Measure |
Units of Measure |
| Units of Presentation |
Units of Presentation |
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 internal project use. |
| Organization Management Services CodeSystem |
Items from https://spor.ema.europa.eu/omswi |
| Products Management Services CodeSystem |
Items from https://spor.ema.europa.eu/pmswi |
| Referentials Management Services CodeSystem |
Items from https://spor.ema.europa.eu/rmswi |
| Substances Management Services CodeSystem |
Items from https://spor.ema.europa.eu/smswi |
These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.
IG © 2021+ . Package hl7.fhir.uv.emedicinal-product-info#1.0.0-ballot based on FHIR 5.0.0-ballot. Generated 2022-12-04
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