EMA Write PMS API Implementation Guide - Enrichments
1.2.1 - ci-build

EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.2.1) 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: 1.2.1
Draft as of 2026-06-26 Computable Name: EmaWriteApiActivityDefinition

Defines the rule a ActivityDefinition resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application

Usages:

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.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ActivityDefinition C 0..* EmaWriteApiActivityDefinitionRestrictions The definition of a specific activity to be taken, independent of any particular patient or context
Interfaces Implemented: MetadataResource
Constraints: cnl-0
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
Required Pattern: active
... effectivePeriod Σ 0..1 EmaPeriod When the activity definition is expected to be used
... code Σ 1..1 EmaRefTermCodeableConcept Detail type of activity
Binding: Manufacturing Activity (required)
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... typeReference 1..1 Reference(Organization) Who or what can participate
..... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
..... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
...... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
...... 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ActivityDefinition.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ActivityDefinition.code Base required Manufacturing Activity 📦1.2.1 This IG
ActivityDefinition.participant.​typeReference.identifier.​use Base required IdentifierUse 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
cnl-0 warning ActivityDefinition Name should be usable as an identifier for the module by machine processing applications such as code generation name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from EmaWriteApiActivityDefinitionRestrictions

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ActivityDefinition 0..* EmaWriteApiActivityDefinitionRestrictions The definition of a specific activity to be taken, independent of any particular patient or context
Interfaces Implemented: MetadataResource
... 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)

Path Status Usage ValueSet Version Source
ActivityDefinition.code Base required Manufacturing Activity 📦1.2.1 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ActivityDefinition C 0..* EmaWriteApiActivityDefinitionRestrictions The definition of a specific activity to be taken, independent of any particular patient or context
Interfaces Implemented: MetadataResource
Constraints: cnl-0
... 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

Path Status Usage ValueSet Version Source
ActivityDefinition.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ActivityDefinition.code Base required Manufacturing Activity 📦1.2.1 This IG
ActivityDefinition.participant.​type Base required Action Participant Type 📍5.0.0 FHIR Std.
ActivityDefinition.participant.​typeReference.type Base extensible Resource Types 📍5.0.0 FHIR Std.
ActivityDefinition.participant.​typeReference.identifier.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
ActivityDefinition.participant.​typeReference.identifier.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
ActivityDefinition.participant.​role Base example Action Participant Role 📦2.0.0 THO v7.2
ActivityDefinition.participant.​function Base example Action Participant Function 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
cnl-0 warning ActivityDefinition Name should be usable as an identifier for the module by machine processing applications such as code generation name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ActivityDefinition C 0..* EmaWriteApiActivityDefinitionRestrictions The definition of a specific activity to be taken, independent of any particular patient or context
Interfaces Implemented: MetadataResource
Constraints: cnl-0
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.
Required Pattern: active
... effectivePeriod Σ 0..1 EmaPeriod When the activity definition is expected to be used
... code Σ 1..1 EmaRefTermCodeableConcept Detail type of activity
Binding: Manufacturing Activity (required)
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... typeReference 1..1 Reference(Organization) Who or what can participate
..... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
..... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
...... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
...... 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ActivityDefinition.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ActivityDefinition.code Base required Manufacturing Activity 📦1.2.1 This IG
ActivityDefinition.participant.​typeReference.identifier.​use Base required IdentifierUse 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
cnl-0 warning ActivityDefinition Name should be usable as an identifier for the module by machine processing applications such as code generation name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Differential View

This structure is derived from EmaWriteApiActivityDefinitionRestrictions

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ActivityDefinition 0..* EmaWriteApiActivityDefinitionRestrictions The definition of a specific activity to be taken, independent of any particular patient or context
Interfaces Implemented: MetadataResource
... 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)

Path Status Usage ValueSet Version Source
ActivityDefinition.code Base required Manufacturing Activity 📦1.2.1 This IG

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ActivityDefinition C 0..* EmaWriteApiActivityDefinitionRestrictions The definition of a specific activity to be taken, independent of any particular patient or context
Interfaces Implemented: MetadataResource
Constraints: cnl-0
... 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

Path Status Usage ValueSet Version Source
ActivityDefinition.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ActivityDefinition.code Base required Manufacturing Activity 📦1.2.1 This IG
ActivityDefinition.participant.​type Base required Action Participant Type 📍5.0.0 FHIR Std.
ActivityDefinition.participant.​typeReference.type Base extensible Resource Types 📍5.0.0 FHIR Std.
ActivityDefinition.participant.​typeReference.identifier.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
ActivityDefinition.participant.​typeReference.identifier.​type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
ActivityDefinition.participant.​role Base example Action Participant Role 📦2.0.0 THO v7.2
ActivityDefinition.participant.​function Base example Action Participant Function 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
cnl-0 warning ActivityDefinition Name should be usable as an identifier for the module by machine processing applications such as code generation name.exists() implies name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

 

Other representations of profile: CSV, Excel, Schematron