European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
1.0.0 - ci-build

European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: 01 EU EPI Bundle

Official URL: http://ema.europa.eu/fhir/StructureDefinition/EUEpiBundle Version: 1.0.0
Active as of 2025-04-02 Computable Name: EUEpiBundle

This profile represents the constraints applied to the Bundle resource used in ePI, as defined by the EU ePI Common Standard. ePI is composed of multiple documents (summary of product characteristics, package leaflet, etc.). Each document is represented by a Bundle with type=document.

This profile represents the constraints applied to the Bundle resource used to create an Electronic Product Information (EPI) document.

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraintsdoco
.. Bundle C 0..* Bundle Contains a collection of resources
bdl-1: total only when a search or history
bdl-2: entry.search only when a search
bdl-7: FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles)
bdl-9: A document must have an identifier with a system and a value
bdl-10: A document must have a date
bdl-11: A document must have a Composition as the first resource
bdl-12: A message must have a MessageHeader as the first resource
bdl-13: A subscription-notification must have a SubscriptionStatus as the first resource
bdl-14: entry.request.method PATCH not allowed for history
bdl-15: Bundle resources where type is not transaction, transaction-response, batch, or batch-response or when the request is a POST SHALL have Bundle.entry.fullUrl populated
bdl-16: Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'.
bdl-17: Use and meaning of issues for documents has not been validated because the content will not be rendered in the document.
bdl-18: Self link is required for searchsets.
bdl-3a: For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements
bdl-3b: For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH
bdl-3c: For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH
bdl-3d: For collections of type transaction-response or batch-response, all entries must contain response elements
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
ele-1: All FHIR elements must have a @value or children
... identifier ΣC 0..1 Identifier Persistent business identifier for the Bundle.
ele-1: All FHIR elements must have a @value or children
... type ΣC 1..1 code document | message | transaction | transaction-response | batch | batch-response | history | searchset | collection | subscription-notification
Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used.


ele-1: All FHIR elements must have a @value or children
Required Pattern: document
... link ΣC 0..* BackboneElement Support to XHTML content styling referencing an CSS stylesheet.
ele-1: All FHIR elements must have a @value or children
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... relation ΣC 1..1 code See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1
Binding: LinkRelationTypes (required)
ele-1: All FHIR elements must have a @value or children
Required Pattern: stylesheet
.... url ΣC 1..1 uri Reference details for the link
ele-1: All FHIR elements must have a @value or children
... Slices for entry ΣC 1..* BackboneElement Entry resource in the EPI bundle.
Slice: Unordered, Open by type:$this.resource
bdl-5: must be a resource unless there's a request or response
bdl-8: fullUrl cannot be a version specific reference
ele-1: All FHIR elements must have a @value or children
This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
.... entry:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... fullUrl ΣC 1..1 uri URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
ele-1: All FHIR elements must have a @value or children
..... resource ΣC 1..1 Resource A resource in the bundle
.... entry:composition ΣC 1..1 BackboneElement EPI Composition
bdl-5: must be a resource unless there's a request or response
bdl-8: fullUrl cannot be a version specific reference
ele-1: All FHIR elements must have a @value or children
This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... fullUrl ΣC 0..1 uri URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
ele-1: All FHIR elements must have a @value or children
..... resource ΣC 0..1 Composition A resource in the bundle
..... request ΣC 0..1 BackboneElement Additional execution information (transaction/batch/history)
ele-1: All FHIR elements must have a @value or children
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
...... method ΣC 1..1 code GET | HEAD | POST | PUT | DELETE | PATCH
Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details.


ele-1: All FHIR elements must have a @value or children
...... url Σ 1..1 uri URL for HTTP equivalent of this entry
ele-1: All FHIR elements must have a @value or children
..... response ΣC 0..1 BackboneElement Results of execution (transaction/batch/history)
ele-1: All FHIR elements must have a @value or children
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
...... status Σ 1..1 string Status response code (text optional)
ele-1: All FHIR elements must have a @value or children
... issues ΣC 0..1 OperationOutcome Issues with the Bundle

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Bundle.typerequiredPattern: document
http://hl7.org/fhir/ValueSet/bundle-type|5.0.0
from the FHIR Standard
Bundle.link.relationrequiredPattern: stylesheet
http://hl7.org/fhir/ValueSet/iana-link-relations|5.0.0
from the FHIR Standard
Bundle.entry.request.methodrequiredHTTPVerb
http://hl7.org/fhir/ValueSet/http-verb|5.0.0
from the FHIR Standard
Bundle.entry:composition.request.methodrequiredHTTPVerb
http://hl7.org/fhir/ValueSet/http-verb|5.0.0
from the FHIR Standard

 

Other representations of profile: CSV, Excel, Schematron