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

Resource Profile: EMA Write API ActivityDefinition

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:

Formal Views of Profile Content

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

NameFlagsCard.TypeDescription & Constraintsdoco
.. ActivityDefinition 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
... status ?!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
... effectivePeriod Σ 0..1 EmaPeriod When the activity definition is expected to be used
ele-1: All FHIR elements must have a @value or children
... code Σ 1..1 EmaRefTermCodeableConcept Detail type of activity
Binding: Manufacturing Activity (required)
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
.... typeReference 1..1 Reference(Organization) Who or what can participate
ele-1: All FHIR elements must have a @value or children
..... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
ele-1: All FHIR elements must have a @value or children
..... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
ele-1: All FHIR elements must have a @value or children
...... use ?!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
...... system 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
...... value ΣC 1..1 string The value that is unique
ele-1: All FHIR elements must have a @value or children
Example General: 123456

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
ActivityDefinition.statusrequiredPattern: active
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
ActivityDefinition.coderequiredManufacturingActivityVs (a valid code from Manufacturing Activity Value Set)
http://ema.europa.eu/fhir/vs/manufacturingActivity
from this IG
ActivityDefinition.participant.typeReference.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard

This structure is derived from EmaWriteApiActivityDefinitionRestrictions

NameFlagsCard.TypeDescription & Constraintsdoco
.. ActivityDefinition 0..* EmaWriteApiActivityDefinitionRestrictions The definition of a specific activity to be taken, independent of any particular patient or context
... status 1..1 code draft | active | retired | unknown
Required Pattern: active
... effectivePeriod 0..1 EmaPeriod When the activity definition is expected to be used
... code 1..1 EmaRefTermCodeableConcept Detail type of activity
Binding: Manufacturing Activity (required)
.... typeReference 1..1 Reference(Organization) Who or what can participate
..... identifier 1..1 Identifier Logical reference, when literal reference is not known
...... system 0..1 uri The namespace for the identifier value
Required Pattern: http://spor.ema.europa.eu/v1/locations
...... value 1..1 string The value that is unique

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
ActivityDefinition.coderequiredManufacturingActivityVs (a valid code from Manufacturing Activity Value Set)
http://ema.europa.eu/fhir/vs/manufacturingActivity
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. ActivityDefinition 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
... id Σ 0..1 id Logical id of this artifact
... extension 0..* Extension Additional content defined by implementations
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.


Required Pattern: active
... code Σ 1..1 EmaRefTermCodeableConcept Detail type of activity
Binding: Manufacturing Activity (required)
... participant 1..1 BackboneElement Who should participate in the action
.... 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
.... type 0..1 code careteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson
Binding: ActionParticipantType (required): The type of participant in the activity.

.... typeCanonical 0..1 canonical(CapabilityStatement) Who or what can participate
.... typeReference 1..1 Reference(Organization) Who or what can participate
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
..... type 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).

..... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

...... type 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.

...... system Σ 0..1 uri The namespace for the identifier value
Required Pattern: http://spor.ema.europa.eu/v1/locations
...... value ΣC 1..1 string The value that is unique
Example General: 123456
...... period Σ 0..1 Period Time period when id is/was valid for use
...... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
..... display ΣC 0..1 string Text alternative for the resource
.... role 0..1 CodeableConcept E.g. Nurse, Surgeon, Parent, etc
Binding: Action Participant Role (example): Defines roles played by participants for the action.

.... function 0..1 CodeableConcept E.g. Author, Reviewer, Witness, etc
Binding: ActionParticipantFunction (example)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
ActivityDefinition.statusrequiredPattern: active
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
ActivityDefinition.coderequiredManufacturingActivityVs (a valid code from Manufacturing Activity Value Set)
http://ema.europa.eu/fhir/vs/manufacturingActivity
from this IG
ActivityDefinition.participant.typerequiredActionParticipantType
http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0
from the FHIR Standard
ActivityDefinition.participant.typeReference.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
ActivityDefinition.participant.typeReference.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
ActivityDefinition.participant.typeReference.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
ActivityDefinition.participant.roleexampleActionParticipantRole
http://terminology.hl7.org/ValueSet/action-participant-role
ActivityDefinition.participant.functionexampleActionParticipantFunction
http://hl7.org/fhir/ValueSet/action-participant-function
from the FHIR Standard

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ActivityDefinition 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
... status ?!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
... effectivePeriod Σ 0..1 EmaPeriod When the activity definition is expected to be used
ele-1: All FHIR elements must have a @value or children
... code Σ 1..1 EmaRefTermCodeableConcept Detail type of activity
Binding: Manufacturing Activity (required)
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
.... typeReference 1..1 Reference(Organization) Who or what can participate
ele-1: All FHIR elements must have a @value or children
..... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
ele-1: All FHIR elements must have a @value or children
..... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
ele-1: All FHIR elements must have a @value or children
...... use ?!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
...... system 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
...... value ΣC 1..1 string The value that is unique
ele-1: All FHIR elements must have a @value or children
Example General: 123456

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
ActivityDefinition.statusrequiredPattern: active
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
ActivityDefinition.coderequiredManufacturingActivityVs (a valid code from Manufacturing Activity Value Set)
http://ema.europa.eu/fhir/vs/manufacturingActivity
from this IG
ActivityDefinition.participant.typeReference.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard

Differential View

This structure is derived from EmaWriteApiActivityDefinitionRestrictions

NameFlagsCard.TypeDescription & Constraintsdoco
.. ActivityDefinition 0..* EmaWriteApiActivityDefinitionRestrictions The definition of a specific activity to be taken, independent of any particular patient or context
... status 1..1 code draft | active | retired | unknown
Required Pattern: active
... effectivePeriod 0..1 EmaPeriod When the activity definition is expected to be used
... code 1..1 EmaRefTermCodeableConcept Detail type of activity
Binding: Manufacturing Activity (required)
.... typeReference 1..1 Reference(Organization) Who or what can participate
..... identifier 1..1 Identifier Logical reference, when literal reference is not known
...... system 0..1 uri The namespace for the identifier value
Required Pattern: http://spor.ema.europa.eu/v1/locations
...... value 1..1 string The value that is unique

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
ActivityDefinition.coderequiredManufacturingActivityVs (a valid code from Manufacturing Activity Value Set)
http://ema.europa.eu/fhir/vs/manufacturingActivity
from this IG

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ActivityDefinition 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
... id Σ 0..1 id Logical id of this artifact
... extension 0..* Extension Additional content defined by implementations
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.


Required Pattern: active
... code Σ 1..1 EmaRefTermCodeableConcept Detail type of activity
Binding: Manufacturing Activity (required)
... participant 1..1 BackboneElement Who should participate in the action
.... 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
.... type 0..1 code careteam | device | group | healthcareservice | location | organization | patient | practitioner | practitionerrole | relatedperson
Binding: ActionParticipantType (required): The type of participant in the activity.

.... typeCanonical 0..1 canonical(CapabilityStatement) Who or what can participate
.... typeReference 1..1 Reference(Organization) Who or what can participate
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
..... type 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).

..... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

...... type 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.

...... system Σ 0..1 uri The namespace for the identifier value
Required Pattern: http://spor.ema.europa.eu/v1/locations
...... value ΣC 1..1 string The value that is unique
Example General: 123456
...... period Σ 0..1 Period Time period when id is/was valid for use
...... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
..... display ΣC 0..1 string Text alternative for the resource
.... role 0..1 CodeableConcept E.g. Nurse, Surgeon, Parent, etc
Binding: Action Participant Role (example): Defines roles played by participants for the action.

.... function 0..1 CodeableConcept E.g. Author, Reviewer, Witness, etc
Binding: ActionParticipantFunction (example)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
ActivityDefinition.statusrequiredPattern: active
http://hl7.org/fhir/ValueSet/publication-status|5.0.0
from the FHIR Standard
ActivityDefinition.coderequiredManufacturingActivityVs (a valid code from Manufacturing Activity Value Set)
http://ema.europa.eu/fhir/vs/manufacturingActivity
from this IG
ActivityDefinition.participant.typerequiredActionParticipantType
http://hl7.org/fhir/ValueSet/action-participant-type|5.0.0
from the FHIR Standard
ActivityDefinition.participant.typeReference.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
ActivityDefinition.participant.typeReference.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
ActivityDefinition.participant.typeReference.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
ActivityDefinition.participant.roleexampleActionParticipantRole
http://terminology.hl7.org/ValueSet/action-participant-role
ActivityDefinition.participant.functionexampleActionParticipantFunction
http://hl7.org/fhir/ValueSet/action-participant-function
from the FHIR Standard

 

Other representations of profile: CSV, Excel, Schematron