Resource Profile: 01 EU EPI Bundle
| Official URL: http://ema.europa.eu/fhir/StructureDefinition/EUEpiBundle | Version: 1.0.0 | |||
| Active as of 2026-08-26 | 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.
Usages:
- This Profile is not used by any profiles in this Specification
You can also check for usages in the FHIR IG Statistics
Formal Views of Profile Content
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints Filter:   |
|---|---|---|---|---|
  Bundle |
C | 0..* | Bundle | Contains a collection of resources Constraints: bdl-1, bdl-2, bdl-7, bdl-9, bdl-10, bdl-11, bdl-12, bdl-13, bdl-14, bdl-15, bdl-16, bdl-17, bdl-18, bdl-3a, bdl-3b, bdl-3c, bdl-3d |
  implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
 identifier |
ΣC | 0..1 | Identifier | Persistent business identifier for the Bundle. |
| 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. Required Pattern: document |
| timestamp |
ΣC | 1..1 | instant | Persistent original date of approval. |
 link |
ΣC | 0..* | BackboneElement | Support to XHTML content styling referencing an CSS stylesheet. |
  modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| relation |
ΣC | 1..1 | code | See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1 Binding: LinkRelationTypes (required) Required Pattern: stylesheet |
 url |
ΣC | 1..1 | uri | Reference details for the link |
 Slices for entry |
ΣC | 1..* | BackboneElement | Entry resource in the EPI bundle. Slice: Unordered, Open by type:$this.resource Constraints: bdl-5, bdl-8 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 |
| fullUrl |
ΣC | 1..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
 resource |
ΣC | 1..1 | Resource | A resource in the bundle |
  entry:composition |
ΣC | 1..1 | BackboneElement | EPI Composition Constraints: bdl-5, bdl-8 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 |
| fullUrl |
ΣC | 1..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
 resource |
ΣC | 1..1 | Composition | A resource in the bundle |
| issues |
ΣC | 0..1 | OperationOutcome(5.0.0) | Issues with the Bundle |
| Documentation for this format | ||||
Terminology Bindings
| Path | Status | Usage | ValueSet | Version | Source |
| Bundle.type | Base | required | Bundle Type | 📍5.0.0 | FHIR Std. |
| Bundle.link.relation | Base | required | Link Relation Types | 📍5.0.0 | FHIR Std. |
| Bundle.entry.request.method | Base | required | H T T P Verb | 📍5.0.0 | FHIR Std. |
| Bundle.entry:composition.request.method | Base | required | H T T P Verb | 📍5.0.0 | FHIR Std. |
Constraints
| Id | Grade | Path(s) | Description | Expression |
This structure is derived from Bundle
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Bundle |
0..* | Bundle | Contains a collection of resources | |
| identifier |
0..1 | Identifier | Persistent business identifier for the Bundle. | |
| type |
1..1 | code | document | message | transaction | transaction-response | batch | batch-response | history | searchset | collection | subscription-notification Required Pattern: document | |
| timestamp |
1..1 | instant | Persistent original date of approval. | |
| link |
0..* | BackboneElement | Support to XHTML content styling referencing an CSS stylesheet. | |
| relation |
1..1 | code | See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1 Required Pattern: stylesheet | |
 Slices for entry |
1..* | BackboneElement | Entry resource in the EPI bundle. Slice: Unordered, Open by type:$this.resource | |
| entry:All Slices |
Content/Rules for all slices | |||
| fullUrl |
1..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) | |
| resource |
1..1 | Resource | A resource in the bundle | |
| search |
0..0 | Search related information | ||
| request |
0..0 | Additional execution information (transaction/batch/history) | ||
| response |
0..0 | Results of execution (transaction/batch/history) | ||
| entry:composition |
1..1 | BackboneElement | EPI Composition | |
| resource |
1..1 | Composition | A resource in the bundle | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| Bundle |
C | 0..* | Bundle | Contains a collection of resources Constraints: bdl-1, bdl-2, bdl-7, bdl-9, bdl-10, bdl-11, bdl-12, bdl-13, bdl-14, bdl-15, bdl-16, bdl-17, bdl-18, bdl-3a, bdl-3b, bdl-3c, bdl-3d | ||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| identifier |
ΣC | 0..1 | Identifier | Persistent business identifier for the Bundle. | ||||
| 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. Required Pattern: document | ||||
| timestamp |
ΣC | 1..1 | instant | Persistent original date of approval. | ||||
| total |
ΣC | 0..1 | unsignedInt | If search, the total number of matches | ||||
| link |
ΣC | 0..* | BackboneElement | Support to XHTML content styling referencing an CSS stylesheet. | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
 extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| relation |
ΣC | 1..1 | code | See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1 Binding: LinkRelationTypes (required) Required Pattern: stylesheet | ||||
| url |
ΣC | 1..1 | uri | Reference details for the link | ||||
| Slices for entry |
ΣC | 1..* | BackboneElement | Entry resource in the EPI bundle. Slice: Unordered, Open by type:$this.resource Constraints: bdl-5, bdl-8 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 | |||||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| link |
Σ | 0..* | See link (Bundle) | Links related to this entry | ||||
| fullUrl |
ΣC | 1..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) | ||||
| resource |
ΣC | 1..1 | Resource | A resource in the bundle | ||||
| entry:composition |
ΣC | 1..1 | BackboneElement | EPI Composition Constraints: bdl-5, bdl-8 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 | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| link |
Σ | 0..* | See link (Bundle) | Links related to this entry | ||||
| fullUrl |
ΣC | 1..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) | ||||
| resource |
ΣC | 1..1 | Composition | A resource in the bundle | ||||
| signature |
Σ | 0..1 | Signature | Digital Signature | ||||
| issues |
ΣC | 0..1 | OperationOutcome(5.0.0) | Issues with the Bundle | ||||
| Documentation for this format | ||||||||
Terminology Bindings
| Path | Status | Usage | ValueSet | Version | Source |
| Bundle.language | Base | required | All Languages | 📍5.0.0 | FHIR Std. |
| Bundle.type | Base | required | Bundle Type | 📍5.0.0 | FHIR Std. |
| Bundle.link.relation | Base | required | Link Relation Types | 📍5.0.0 | FHIR Std. |
| Bundle.entry.search.mode | Base | required | Search Entry Mode | 📍5.0.0 | FHIR Std. |
| Bundle.entry.request.method | Base | required | H T T P Verb | 📍5.0.0 | FHIR Std. |
| Bundle.entry:composition.search.mode | Base | required | Search Entry Mode | 📍5.0.0 | FHIR Std. |
| Bundle.entry:composition.request.method | Base | required | H T T P Verb | 📍5.0.0 | FHIR Std. |
Constraints
| Id | Grade | Path(s) | Description | Expression |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Bundle |
C | 0..* | Bundle | Contains a collection of resources Constraints: bdl-1, bdl-2, bdl-7, bdl-9, bdl-10, bdl-11, bdl-12, bdl-13, bdl-14, bdl-15, bdl-16, bdl-17, bdl-18, bdl-3a, bdl-3b, bdl-3c, bdl-3d |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| identifier |
ΣC | 0..1 | Identifier | Persistent business identifier for the Bundle. |
| 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. Required Pattern: document |
| timestamp |
ΣC | 1..1 | instant | Persistent original date of approval. |
| link |
ΣC | 0..* | BackboneElement | Support to XHTML content styling referencing an CSS stylesheet. |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| relation |
ΣC | 1..1 | code | See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1 Binding: LinkRelationTypes (required) Required Pattern: stylesheet |
| url |
ΣC | 1..1 | uri | Reference details for the link |
| Slices for entry |
ΣC | 1..* | BackboneElement | Entry resource in the EPI bundle. Slice: Unordered, Open by type:$this.resource Constraints: bdl-5, bdl-8 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 |
| fullUrl |
ΣC | 1..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource |
ΣC | 1..1 | Resource | A resource in the bundle |
| entry:composition |
ΣC | 1..1 | BackboneElement | EPI Composition Constraints: bdl-5, bdl-8 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 |
| fullUrl |
ΣC | 1..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource |
ΣC | 1..1 | Composition | A resource in the bundle |
| issues |
ΣC | 0..1 | OperationOutcome(5.0.0) | Issues with the Bundle |
| Documentation for this format | ||||
Terminology Bindings
| Path | Status | Usage | ValueSet | Version | Source |
| Bundle.type | Base | required | Bundle Type | 📍5.0.0 | FHIR Std. |
| Bundle.link.relation | Base | required | Link Relation Types | 📍5.0.0 | FHIR Std. |
| Bundle.entry.request.method | Base | required | H T T P Verb | 📍5.0.0 | FHIR Std. |
| Bundle.entry:composition.request.method | Base | required | H T T P Verb | 📍5.0.0 | FHIR Std. |
Constraints
| Id | Grade | Path(s) | Description | Expression |
Differential View
This structure is derived from Bundle
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Bundle |
0..* | Bundle | Contains a collection of resources | |
| identifier |
0..1 | Identifier | Persistent business identifier for the Bundle. | |
| type |
1..1 | code | document | message | transaction | transaction-response | batch | batch-response | history | searchset | collection | subscription-notification Required Pattern: document | |
| timestamp |
1..1 | instant | Persistent original date of approval. | |
| link |
0..* | BackboneElement | Support to XHTML content styling referencing an CSS stylesheet. | |
| relation |
1..1 | code | See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1 Required Pattern: stylesheet | |
| Slices for entry |
1..* | BackboneElement | Entry resource in the EPI bundle. Slice: Unordered, Open by type:$this.resource | |
| entry:All Slices |
Content/Rules for all slices | |||
| fullUrl |
1..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) | |
| resource |
1..1 | Resource | A resource in the bundle | |
| search |
0..0 | Search related information | ||
| request |
0..0 | Additional execution information (transaction/batch/history) | ||
| response |
0..0 | Results of execution (transaction/batch/history) | ||
| entry:composition |
1..1 | BackboneElement | EPI Composition | |
| resource |
1..1 | Composition | A resource in the bundle | |
| Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| Bundle |
C | 0..* | Bundle | Contains a collection of resources Constraints: bdl-1, bdl-2, bdl-7, bdl-9, bdl-10, bdl-11, bdl-12, bdl-13, bdl-14, bdl-15, bdl-16, bdl-17, bdl-18, bdl-3a, bdl-3b, bdl-3c, bdl-3d | ||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| identifier |
ΣC | 0..1 | Identifier | Persistent business identifier for the Bundle. | ||||
| 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. Required Pattern: document | ||||
| timestamp |
ΣC | 1..1 | instant | Persistent original date of approval. | ||||
| total |
ΣC | 0..1 | unsignedInt | If search, the total number of matches | ||||
| link |
ΣC | 0..* | BackboneElement | Support to XHTML content styling referencing an CSS stylesheet. | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| relation |
ΣC | 1..1 | code | See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1 Binding: LinkRelationTypes (required) Required Pattern: stylesheet | ||||
| url |
ΣC | 1..1 | uri | Reference details for the link | ||||
| Slices for entry |
ΣC | 1..* | BackboneElement | Entry resource in the EPI bundle. Slice: Unordered, Open by type:$this.resource Constraints: bdl-5, bdl-8 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 | |||||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| link |
Σ | 0..* | See link (Bundle) | Links related to this entry | ||||
| fullUrl |
ΣC | 1..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) | ||||
| resource |
ΣC | 1..1 | Resource | A resource in the bundle | ||||
| entry:composition |
ΣC | 1..1 | BackboneElement | EPI Composition Constraints: bdl-5, bdl-8 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 | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| link |
Σ | 0..* | See link (Bundle) | Links related to this entry | ||||
| fullUrl |
ΣC | 1..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) | ||||
| resource |
ΣC | 1..1 | Composition | A resource in the bundle | ||||
| signature |
Σ | 0..1 | Signature | Digital Signature | ||||
| issues |
ΣC | 0..1 | OperationOutcome(5.0.0) | Issues with the Bundle | ||||
| Documentation for this format | ||||||||
Terminology Bindings
| Path | Status | Usage | ValueSet | Version | Source |
| Bundle.language | Base | required | All Languages | 📍5.0.0 | FHIR Std. |
| Bundle.type | Base | required | Bundle Type | 📍5.0.0 | FHIR Std. |
| Bundle.link.relation | Base | required | Link Relation Types | 📍5.0.0 | FHIR Std. |
| Bundle.entry.search.mode | Base | required | Search Entry Mode | 📍5.0.0 | FHIR Std. |
| Bundle.entry.request.method | Base | required | H T T P Verb | 📍5.0.0 | FHIR Std. |
| Bundle.entry:composition.search.mode | Base | required | Search Entry Mode | 📍5.0.0 | FHIR Std. |
| Bundle.entry:composition.request.method | Base | required | H T T P Verb | 📍5.0.0 | FHIR Std. |
Constraints
| Id | Grade | Path(s) | Description | Expression |
Other representations of profile: CSV, Excel, Schematron