EMA Write PMS API Implementation Guide - Enrichments
1.2.0 - ci-build
EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Official URL: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiActivityDefinition | Version: 1.2.0 | |||
| Draft as of 2025-08-08 | Computable Name: EmaWriteApiActivityDefinition | |||
Defines the rule a ActivityDefinition resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints![]() |
|---|---|---|---|---|
![]() |
C | 0..* | EmaWriteApiActivityDefinitionRestrictions | The definition of a specific activity to be taken, independent of any particular patient or context cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation |
![]() ![]() |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children Required Pattern: active |
![]() ![]() |
Σ | 0..1 | EmaPeriod | When the activity definition is expected to be used ele-1: All FHIR elements must have a @value or children |
![]() ![]() |
Σ | 1..1 | EmaRefTermCodeableConcept | Detail type of activity Binding: Manufacturing Activity (required) ele-1: All FHIR elements must have a @value or children |
![]() ![]() |
1..1 | BackboneElement | Who should participate in the action ele-1: All FHIR elements must have a @value or children | |
![]() ![]() ![]() |
?!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 |
![]() ![]() ![]() |
1..1 | Reference(Organization) | Who or what can participate ele-1: All FHIR elements must have a @value or children | |
![]() ![]() ![]() ![]() |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL ele-1: All FHIR elements must have a @value or children |
![]() ![]() ![]() ![]() |
ΣC | 1..1 | Identifier | Logical reference, when literal reference is not known ele-1: All FHIR elements must have a @value or children |
![]() ![]() ![]() ![]() ![]() |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . ele-1: All FHIR elements must have a @value or children |
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | uri | The namespace for the identifier value ele-1: All FHIR elements must have a @value or children Required Pattern: http://spor.ema.europa.eu/v1/locations |
![]() ![]() ![]() ![]() ![]() |
ΣC | 1..1 | string | The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456 |
Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| ActivityDefinition.status | required | Pattern: activehttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| ActivityDefinition.code | required | ManufacturingActivityVs (a valid code from Manufacturing Activity Value Set)http://ema.europa.eu/fhir/vs/manufacturingActivityfrom this IG | |
| ActivityDefinition.participant.typeReference.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard |
This structure is derived from EmaWriteApiActivityDefinitionRestrictions
| Name | Flags | Card. | Type | Description & Constraints![]() |
|---|---|---|---|---|
![]() |
0..* | EmaWriteApiActivityDefinitionRestrictions | The definition of a specific activity to be taken, independent of any particular patient or context | |
![]() ![]() |
1..1 | code | draft | active | retired | unknown Required Pattern: active | |
![]() ![]() |
0..1 | EmaPeriod | When the activity definition is expected to be used | |
![]() ![]() |
1..1 | EmaRefTermCodeableConcept | Detail type of activity Binding: Manufacturing Activity (required) | |
![]() ![]() |
1..1 | BackboneElement | Who should participate in the action | |
![]() ![]() ![]() |
1..1 | Reference(Organization) | Who or what can participate | |
![]() ![]() ![]() ![]() |
1..1 | Identifier | Logical reference, when literal reference is not known | |
![]() ![]() ![]() ![]() ![]() |
0..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/locations | |
![]() ![]() ![]() ![]() ![]() |
1..1 | string | The value that is unique | |
Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| ActivityDefinition.code | required | ManufacturingActivityVs (a valid code from Manufacturing Activity Value Set)http://ema.europa.eu/fhir/vs/manufacturingActivityfrom this IG |
| Name | Flags | Card. | Type | Description & Constraints![]() |
|---|---|---|---|---|
![]() |
C | 0..* | EmaWriteApiActivityDefinitionRestrictions | The definition of a specific activity to be taken, independent of any particular patient or context cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation |
![]() ![]() |
Σ | 0..1 | id | Logical id of this artifact |
![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. Required Pattern: active |
![]() ![]() |
Σ | 0..1 | EmaPeriod | When the activity definition is expected to be used |
![]() ![]() |
Σ | 1..1 | EmaRefTermCodeableConcept | Detail type of activity Binding: Manufacturing Activity (required) |
![]() ![]() |
1..1 | BackboneElement | Who should participate in the action | |
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() |
0..1 | code | careteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson Binding: ActionParticipantType (required): The type of participant in the activity. | |
![]() ![]() ![]() |
0..1 | canonical(CapabilityStatement) | Who or what can participate | |
![]() ![]() ![]() |
1..1 | Reference(Organization) | Who or what can participate | |
![]() ![]() ![]() ![]() |
0..1 | id | Unique id for inter-element referencing | |
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
![]() ![]() ![]() ![]() |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL |
![]() ![]() ![]() ![]() |
Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). |
![]() ![]() ![]() ![]() |
ΣC | 1..1 | Identifier | Logical reference, when literal reference is not known |
![]() ![]() ![]() ![]() ![]() |
0..1 | id | Unique id for inter-element referencing | |
![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
![]() ![]() ![]() ![]() ![]() |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/locations |
![]() ![]() ![]() ![]() ![]() |
ΣC | 1..1 | string | The value that is unique Example General: 123456 |
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | Period | Time period when id is/was valid for use |
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
![]() ![]() ![]() ![]() |
ΣC | 0..1 | string | Text alternative for the resource |
![]() ![]() ![]() |
0..1 | CodeableConcept | E.g. Nurse, Surgeon, Parent, etc Binding: Action Participant Role (example): Defines roles played by participants for the action. | |
![]() ![]() ![]() |
0..1 | CodeableConcept | E.g. Author, Reviewer, Witness, etc Binding: ActionParticipantFunction (example) | |
Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| ActivityDefinition.status | required | Pattern: activehttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| ActivityDefinition.code | required | ManufacturingActivityVs (a valid code from Manufacturing Activity Value Set)http://ema.europa.eu/fhir/vs/manufacturingActivityfrom this IG | |
| ActivityDefinition.participant.type | required | ActionParticipantTypehttp://hl7.org/fhir/ValueSet/action-participant-type|5.0.0from the FHIR Standard | |
| ActivityDefinition.participant.typeReference.type | extensible | ResourceTypehttp://hl7.org/fhir/ValueSet/resource-typesfrom the FHIR Standard | |
| ActivityDefinition.participant.typeReference.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard | |
| ActivityDefinition.participant.typeReference.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-typefrom the FHIR Standard | |
| ActivityDefinition.participant.role | example | ActionParticipantRolehttp://terminology.hl7.org/ValueSet/action-participant-role | |
| ActivityDefinition.participant.function | example | ActionParticipantFunctionhttp://hl7.org/fhir/ValueSet/action-participant-functionfrom the FHIR Standard |
This structure is derived from EmaWriteApiActivityDefinitionRestrictions
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints![]() |
|---|---|---|---|---|
![]() |
C | 0..* | EmaWriteApiActivityDefinitionRestrictions | The definition of a specific activity to be taken, independent of any particular patient or context cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation |
![]() ![]() |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children Required Pattern: active |
![]() ![]() |
Σ | 0..1 | EmaPeriod | When the activity definition is expected to be used ele-1: All FHIR elements must have a @value or children |
![]() ![]() |
Σ | 1..1 | EmaRefTermCodeableConcept | Detail type of activity Binding: Manufacturing Activity (required) ele-1: All FHIR elements must have a @value or children |
![]() ![]() |
1..1 | BackboneElement | Who should participate in the action ele-1: All FHIR elements must have a @value or children | |
![]() ![]() ![]() |
?!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 |
![]() ![]() ![]() |
1..1 | Reference(Organization) | Who or what can participate ele-1: All FHIR elements must have a @value or children | |
![]() ![]() ![]() ![]() |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL ele-1: All FHIR elements must have a @value or children |
![]() ![]() ![]() ![]() |
ΣC | 1..1 | Identifier | Logical reference, when literal reference is not known ele-1: All FHIR elements must have a @value or children |
![]() ![]() ![]() ![]() ![]() |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . ele-1: All FHIR elements must have a @value or children |
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | uri | The namespace for the identifier value ele-1: All FHIR elements must have a @value or children Required Pattern: http://spor.ema.europa.eu/v1/locations |
![]() ![]() ![]() ![]() ![]() |
ΣC | 1..1 | string | The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456 |
Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| ActivityDefinition.status | required | Pattern: activehttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| ActivityDefinition.code | required | ManufacturingActivityVs (a valid code from Manufacturing Activity Value Set)http://ema.europa.eu/fhir/vs/manufacturingActivityfrom this IG | |
| ActivityDefinition.participant.typeReference.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard |
Differential View
This structure is derived from EmaWriteApiActivityDefinitionRestrictions
| Name | Flags | Card. | Type | Description & Constraints![]() |
|---|---|---|---|---|
![]() |
0..* | EmaWriteApiActivityDefinitionRestrictions | The definition of a specific activity to be taken, independent of any particular patient or context | |
![]() ![]() |
1..1 | code | draft | active | retired | unknown Required Pattern: active | |
![]() ![]() |
0..1 | EmaPeriod | When the activity definition is expected to be used | |
![]() ![]() |
1..1 | EmaRefTermCodeableConcept | Detail type of activity Binding: Manufacturing Activity (required) | |
![]() ![]() |
1..1 | BackboneElement | Who should participate in the action | |
![]() ![]() ![]() |
1..1 | Reference(Organization) | Who or what can participate | |
![]() ![]() ![]() ![]() |
1..1 | Identifier | Logical reference, when literal reference is not known | |
![]() ![]() ![]() ![]() ![]() |
0..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/locations | |
![]() ![]() ![]() ![]() ![]() |
1..1 | string | The value that is unique | |
Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| ActivityDefinition.code | required | ManufacturingActivityVs (a valid code from Manufacturing Activity Value Set)http://ema.europa.eu/fhir/vs/manufacturingActivityfrom this IG |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints![]() |
|---|---|---|---|---|
![]() |
C | 0..* | EmaWriteApiActivityDefinitionRestrictions | The definition of a specific activity to be taken, independent of any particular patient or context cnl-0: Name should be usable as an identifier for the module by machine processing applications such as code generation |
![]() ![]() |
Σ | 0..1 | id | Logical id of this artifact |
![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. Required Pattern: active |
![]() ![]() |
Σ | 0..1 | EmaPeriod | When the activity definition is expected to be used |
![]() ![]() |
Σ | 1..1 | EmaRefTermCodeableConcept | Detail type of activity Binding: Manufacturing Activity (required) |
![]() ![]() |
1..1 | BackboneElement | Who should participate in the action | |
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() |
0..1 | code | careteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson Binding: ActionParticipantType (required): The type of participant in the activity. | |
![]() ![]() ![]() |
0..1 | canonical(CapabilityStatement) | Who or what can participate | |
![]() ![]() ![]() |
1..1 | Reference(Organization) | Who or what can participate | |
![]() ![]() ![]() ![]() |
0..1 | id | Unique id for inter-element referencing | |
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
![]() ![]() ![]() ![]() |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL |
![]() ![]() ![]() ![]() |
Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). |
![]() ![]() ![]() ![]() |
ΣC | 1..1 | Identifier | Logical reference, when literal reference is not known |
![]() ![]() ![]() ![]() ![]() |
0..1 | id | Unique id for inter-element referencing | |
![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
![]() ![]() ![]() ![]() ![]() |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/locations |
![]() ![]() ![]() ![]() ![]() |
ΣC | 1..1 | string | The value that is unique Example General: 123456 |
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | Period | Time period when id is/was valid for use |
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
![]() ![]() ![]() ![]() |
ΣC | 0..1 | string | Text alternative for the resource |
![]() ![]() ![]() |
0..1 | CodeableConcept | E.g. Nurse, Surgeon, Parent, etc Binding: Action Participant Role (example): Defines roles played by participants for the action. | |
![]() ![]() ![]() |
0..1 | CodeableConcept | E.g. Author, Reviewer, Witness, etc Binding: ActionParticipantFunction (example) | |
Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| ActivityDefinition.status | required | Pattern: activehttp://hl7.org/fhir/ValueSet/publication-status|5.0.0from the FHIR Standard | |
| ActivityDefinition.code | required | ManufacturingActivityVs (a valid code from Manufacturing Activity Value Set)http://ema.europa.eu/fhir/vs/manufacturingActivityfrom this IG | |
| ActivityDefinition.participant.type | required | ActionParticipantTypehttp://hl7.org/fhir/ValueSet/action-participant-type|5.0.0from the FHIR Standard | |
| ActivityDefinition.participant.typeReference.type | extensible | ResourceTypehttp://hl7.org/fhir/ValueSet/resource-typesfrom the FHIR Standard | |
| ActivityDefinition.participant.typeReference.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard | |
| ActivityDefinition.participant.typeReference.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-typefrom the FHIR Standard | |
| ActivityDefinition.participant.role | example | ActionParticipantRolehttp://terminology.hl7.org/ValueSet/action-participant-role | |
| ActivityDefinition.participant.function | example | ActionParticipantFunctionhttp://hl7.org/fhir/ValueSet/action-participant-functionfrom the FHIR Standard |
This structure is derived from EmaWriteApiActivityDefinitionRestrictions
Other representations of profile: CSV, Excel, Schematron