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

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Resource Profile: 10 EU EPI Composition (CAP Annex II documents)

Profile for QRD validations of CAP Annex II EPI documents

This profile represents the constraints applied to CAP Annex II documents.

Usage:

• This Resource Profile is not used by any profiles in this Implementation Guide

Formal Views of Profile Content

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

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
• All

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
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
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set ele-1: All FHIR elements must have a @value or children Required Pattern: en
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored 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	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition. ele-1: All FHIR elements must have a @value or children
type	Σ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition. ele-1: All FHIR elements must have a @value or children
date	Σ	1..1	dateTime	Composition editing time ele-1: All FHIR elements must have a @value or children
author	Σ	1..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the composition ele-1: All FHIR elements must have a @value or children
title	Σ	1..1	string	Human Readable name/title ele-1: All FHIR elements must have a @value or children
Slices for section	C	1..*	BackboneElement	Composition is broken into sections Slice: Unordered, Closed by value:code.coding.code cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty ele-1: All FHIR elements must have a @value or children
section: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
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
section:QRD-200000029850	C	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty 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
title		1..1	string	ANNEX II ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029851		1..1	BackboneElement	Nested Section 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
title		1..1	string	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029852		1..1	BackboneElement	Nested Section 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
title		1..1	string	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029853		0..1	BackboneElement	Nested Section 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
title		1..1	string	Official batch release ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029854		1..1	BackboneElement	Nested Section 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
title		1..1	string	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029855		1..1	BackboneElement	Nested Section 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
title		1..1	string	Periodic safety update reports (PSURs) ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029856		1..1	BackboneElement	Nested Section 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
title		1..1	string	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029857		1..1	BackboneElement	Nested Section 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
title		1..1	string	Risk management plan (RMP) ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029858		0..1	BackboneElement	Nested Section 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
title		1..1	string	Additional risk minimisation measures ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029859		0..1	BackboneElement	Nested Section 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
title		1..1	string	Obligation to conduct post-authorisation measures ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029860		0..1	BackboneElement	Nested Section 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
title		1..1	string	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Composition.language	required	Pattern: en http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Composition.status	required	CompositionStatus http://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard
Composition.type	preferred	FHIRDocumentTypeCodes http://hl7.org/fhir/ValueSet/doc-typecodes from the FHIR Standard
Composition.section:QRD-200000029850.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029851.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029852.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029852.section:QRD-200000029853.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029854.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029854.section:QRD-200000029855.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029857.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029858.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029859.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029860.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard

This structure is derived from Composition

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
language		0..1	code	Language of the resource content Required Pattern: en
Slices for section		1..*	BackboneElement	Composition is broken into sections Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029850		1..1	BackboneElement	Composition is broken into sections
title		1..1	string	ANNEX II
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029850
Slices for section		4..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029851		1..1	BackboneElement	Nested Section
title		1..1	string	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029851
section		0..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029852		1..1	BackboneElement	Nested Section
title		1..1	string	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029852
Slices for section		0..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029853		0..1	BackboneElement	Nested Section
title		1..1	string	Official batch release
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029853
section		0..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029854		1..1	BackboneElement	Nested Section
title		1..1	string	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029854
Slices for section		1..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029855		1..1	BackboneElement	Nested Section
title		1..1	string	Periodic safety update reports (PSURs)
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029855
section		0..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029856		1..1	BackboneElement	Nested Section
title		1..1	string	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029856
Slices for section		1..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029857		1..1	BackboneElement	Nested Section
title		1..1	string	Risk management plan (RMP)
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029857
section		0..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029858		0..1	BackboneElement	Nested Section
title		1..1	string	Additional risk minimisation measures
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029858
section		0..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029859		0..1	BackboneElement	Nested Section
title		1..1	string	Obligation to conduct post-authorisation measures
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029859
section		0..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029860		0..1	BackboneElement	Nested Section
title		1..1	string	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029860
section		0..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
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 Additional Bindings Purpose CommonLanguages Starter Set Required Pattern: en
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url	Σ	0..1	uri	Canonical identifier for this Composition, represented as a URI (globally unique)
identifier	Σ	0..*	Identifier	Version-independent identifier for the Composition
version	Σ	0..1	string	An explicitly assigned identifer of a variation of the content in the Composition
status	?!Σ	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition.
type	Σ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
category	Σ	0..*	CodeableConcept	Categorization of Composition Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
subject	Σ	0..*	Reference(Resource)	Who and/or what the composition is about
encounter	Σ	0..1	Reference(Encounter)	Context of the Composition
date	Σ	1..1	dateTime	Composition editing time
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
author	Σ	1..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the composition
name	Σ	0..1	string	Name for this Composition (computer friendly)
title	Σ	1..1	string	Human Readable name/title
note		0..*	Annotation	For any additional notes
attester		0..*	BackboneElement	Attests to accuracy of composition
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
mode		1..1	CodeableConcept	personal | professional | legal | official Binding: CompositionAttestationMode (preferred): The way in which a person authenticated a composition.
time		0..1	dateTime	When the composition was attested
party		0..1	Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization)	Who attested the composition
custodian	Σ	0..1	Reference(Organization)	Organization which maintains the composition
relatesTo		0..*	RelatedArtifact	Relationships to other compositions/documents
event	Σ	0..*	BackboneElement	The clinical service(s) being documented
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
period	Σ	0..1	Period	The period covered by the documentation
detail	Σ	0..*	CodeableReference(Resource)	The event(s) being documented, as code(s), reference(s), or both Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
Slices for section	C	1..*	BackboneElement	Composition is broken into sections Slice: Unordered, Closed by value:code.coding.code cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
section: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
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:QRD-200000029850	C	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
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
title		1..1	string	ANNEX II
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029850
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029851		1..1	BackboneElement	Nested Section
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
title		1..1	string	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029851
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029852		1..1	BackboneElement	Nested Section
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
title		1..1	string	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029852
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029853		0..1	BackboneElement	Nested Section
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
title		1..1	string	Official batch release
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029853
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029854		1..1	BackboneElement	Nested Section
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
title		1..1	string	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029854
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029855		1..1	BackboneElement	Nested Section
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
title		1..1	string	Periodic safety update reports (PSURs)
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029855
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029856		1..1	BackboneElement	Nested Section
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
title		1..1	string	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029856
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029857		1..1	BackboneElement	Nested Section
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
title		1..1	string	Risk management plan (RMP)
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029857
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029858		0..1	BackboneElement	Nested Section
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
title		1..1	string	Additional risk minimisation measures
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029858
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029859		0..1	BackboneElement	Nested Section
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
title		1..1	string	Obligation to conduct post-authorisation measures
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029859
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029860		0..1	BackboneElement	Nested Section
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
title		1..1	string	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029860
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Composition.language	required	Pattern: en http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Composition.status	required	CompositionStatus http://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard
Composition.type	preferred	FHIRDocumentTypeCodes http://hl7.org/fhir/ValueSet/doc-typecodes from the FHIR Standard
Composition.category	example	ReferencedItemCategoryValueSet http://hl7.org/fhir/ValueSet/referenced-item-category from the FHIR Standard
Composition.attester.mode	preferred	CompositionAttestationMode http://hl7.org/fhir/ValueSet/composition-attestation-mode from the FHIR Standard
Composition.event.detail	example	ActCode http://terminology.hl7.org/ValueSet/v3-ActCode
Composition.section.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029851.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029851.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029851.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029852.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029852.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029852.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029852.section:QRD-200000029853.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029852.section:QRD-200000029853.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029852.section:QRD-200000029853.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029854.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029854.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029854.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029854.section:QRD-200000029855.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029854.section:QRD-200000029855.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029854.section:QRD-200000029855.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029857.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029857.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029857.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029858.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029858.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029858.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029859.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029859.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029859.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029860.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029860.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029860.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard

This structure is derived from Composition

Summary

Mandatory: 24 elements(30 nested mandatory elements)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Composition.section (Closed)
• The element 1 is sliced based on the value of Composition.section.section (Closed)
• The element 1 is sliced based on the value of Composition.section.section.section (Closed)
• The element 1 is sliced based on the value of Composition.section.section.section.section (Closed)

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
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
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set ele-1: All FHIR elements must have a @value or children Required Pattern: en
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored 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	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition. ele-1: All FHIR elements must have a @value or children
type	Σ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition. ele-1: All FHIR elements must have a @value or children
date	Σ	1..1	dateTime	Composition editing time ele-1: All FHIR elements must have a @value or children
author	Σ	1..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the composition ele-1: All FHIR elements must have a @value or children
title	Σ	1..1	string	Human Readable name/title ele-1: All FHIR elements must have a @value or children
Slices for section	C	1..*	BackboneElement	Composition is broken into sections Slice: Unordered, Closed by value:code.coding.code cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty ele-1: All FHIR elements must have a @value or children
section: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
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
section:QRD-200000029850	C	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty 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
title		1..1	string	ANNEX II ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029851		1..1	BackboneElement	Nested Section 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
title		1..1	string	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029852		1..1	BackboneElement	Nested Section 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
title		1..1	string	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029853		0..1	BackboneElement	Nested Section 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
title		1..1	string	Official batch release ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029854		1..1	BackboneElement	Nested Section 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
title		1..1	string	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029855		1..1	BackboneElement	Nested Section 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
title		1..1	string	Periodic safety update reports (PSURs) ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029856		1..1	BackboneElement	Nested Section 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
title		1..1	string	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029857		1..1	BackboneElement	Nested Section 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
title		1..1	string	Risk management plan (RMP) ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029858		0..1	BackboneElement	Nested Section 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
title		1..1	string	Additional risk minimisation measures ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029859		0..1	BackboneElement	Nested Section 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
title		1..1	string	Obligation to conduct post-authorisation measures ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
section:QRD-200000029860		0..1	BackboneElement	Nested Section 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
title		1..1	string	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES ele-1: All FHIR elements must have a @value or children
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. ele-1: All FHIR elements must have a @value or children
entry	C	0..*	Reference(Resource)	A reference to data that supports this section ele-1: All FHIR elements must have a @value or children
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Composition.language	required	Pattern: en http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Composition.status	required	CompositionStatus http://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard
Composition.type	preferred	FHIRDocumentTypeCodes http://hl7.org/fhir/ValueSet/doc-typecodes from the FHIR Standard
Composition.section:QRD-200000029850.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029851.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029852.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029852.section:QRD-200000029853.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029854.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029854.section:QRD-200000029855.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029857.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029858.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029859.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029860.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard

Differential View

This structure is derived from Composition

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
language		0..1	code	Language of the resource content Required Pattern: en
Slices for section		1..*	BackboneElement	Composition is broken into sections Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029850		1..1	BackboneElement	Composition is broken into sections
title		1..1	string	ANNEX II
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029850
Slices for section		4..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029851		1..1	BackboneElement	Nested Section
title		1..1	string	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029851
section		0..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029852		1..1	BackboneElement	Nested Section
title		1..1	string	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029852
Slices for section		0..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029853		0..1	BackboneElement	Nested Section
title		1..1	string	Official batch release
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029853
section		0..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029854		1..1	BackboneElement	Nested Section
title		1..1	string	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029854
Slices for section		1..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029855		1..1	BackboneElement	Nested Section
title		1..1	string	Periodic safety update reports (PSURs)
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029855
section		0..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029856		1..1	BackboneElement	Nested Section
title		1..1	string	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029856
Slices for section		1..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029857		1..1	BackboneElement	Nested Section
title		1..1	string	Risk management plan (RMP)
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029857
section		0..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029858		0..1	BackboneElement	Nested Section
title		1..1	string	Additional risk minimisation measures
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029858
section		0..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029859		0..1	BackboneElement	Nested Section
title		1..1	string	Obligation to conduct post-authorisation measures
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029859
section		0..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029860		0..1	BackboneElement	Nested Section
title		1..1	string	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
code		1..1	CodeableConcept	Classification of section (recommended)
coding
system		1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
code		1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029860
section		0..*		Nested Section Slice: Unordered, Closed by value:code.coding.code
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
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 Additional Bindings Purpose CommonLanguages Starter Set Required Pattern: en
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url	Σ	0..1	uri	Canonical identifier for this Composition, represented as a URI (globally unique)
identifier	Σ	0..*	Identifier	Version-independent identifier for the Composition
version	Σ	0..1	string	An explicitly assigned identifer of a variation of the content in the Composition
status	?!Σ	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition.
type	Σ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
category	Σ	0..*	CodeableConcept	Categorization of Composition Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
subject	Σ	0..*	Reference(Resource)	Who and/or what the composition is about
encounter	Σ	0..1	Reference(Encounter)	Context of the Composition
date	Σ	1..1	dateTime	Composition editing time
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
author	Σ	1..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the composition
name	Σ	0..1	string	Name for this Composition (computer friendly)
title	Σ	1..1	string	Human Readable name/title
note		0..*	Annotation	For any additional notes
attester		0..*	BackboneElement	Attests to accuracy of composition
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
mode		1..1	CodeableConcept	personal | professional | legal | official Binding: CompositionAttestationMode (preferred): The way in which a person authenticated a composition.
time		0..1	dateTime	When the composition was attested
party		0..1	Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization)	Who attested the composition
custodian	Σ	0..1	Reference(Organization)	Organization which maintains the composition
relatesTo		0..*	RelatedArtifact	Relationships to other compositions/documents
event	Σ	0..*	BackboneElement	The clinical service(s) being documented
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
period	Σ	0..1	Period	The period covered by the documentation
detail	Σ	0..*	CodeableReference(Resource)	The event(s) being documented, as code(s), reference(s), or both Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
Slices for section	C	1..*	BackboneElement	Composition is broken into sections Slice: Unordered, Closed by value:code.coding.code cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
section: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
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:QRD-200000029850	C	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
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
title		1..1	string	ANNEX II
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029850
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029851		1..1	BackboneElement	Nested Section
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
title		1..1	string	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029851
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029852		1..1	BackboneElement	Nested Section
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
title		1..1	string	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029852
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029853		0..1	BackboneElement	Nested Section
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
title		1..1	string	Official batch release
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029853
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029854		1..1	BackboneElement	Nested Section
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
title		1..1	string	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029854
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029855		1..1	BackboneElement	Nested Section
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
title		1..1	string	Periodic safety update reports (PSURs)
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029855
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029856		1..1	BackboneElement	Nested Section
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
title		1..1	string	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029856
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029857		1..1	BackboneElement	Nested Section
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
title		1..1	string	Risk management plan (RMP)
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029857
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029858		0..1	BackboneElement	Nested Section
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
title		1..1	string	Additional risk minimisation measures
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029858
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029859		0..1	BackboneElement	Nested Section
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
title		1..1	string	Obligation to conduct post-authorisation measures
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029859
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:QRD-200000029860		0..1	BackboneElement	Nested Section
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
title		1..1	string	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
code		1..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system Required Pattern: 200000029860
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Composition.language	required	Pattern: en http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Composition.status	required	CompositionStatus http://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard
Composition.type	preferred	FHIRDocumentTypeCodes http://hl7.org/fhir/ValueSet/doc-typecodes from the FHIR Standard
Composition.category	example	ReferencedItemCategoryValueSet http://hl7.org/fhir/ValueSet/referenced-item-category from the FHIR Standard
Composition.attester.mode	preferred	CompositionAttestationMode http://hl7.org/fhir/ValueSet/composition-attestation-mode from the FHIR Standard
Composition.event.detail	example	ActCode http://terminology.hl7.org/ValueSet/v3-ActCode
Composition.section.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029851.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029851.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029851.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029852.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029852.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029852.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029852.section:QRD-200000029853.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029852.section:QRD-200000029853.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029852.section:QRD-200000029853.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029854.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029854.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029854.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029854.section:QRD-200000029855.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029854.section:QRD-200000029855.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029854.section:QRD-200000029855.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029857.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029857.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029857.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029858.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029858.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029858.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029859.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029859.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029856.section:QRD-200000029859.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029860.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029860.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section:QRD-200000029850.section:QRD-200000029860.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard

This structure is derived from Composition

Summary

Mandatory: 24 elements(30 nested mandatory elements)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Composition.section (Closed)
• The element 1 is sliced based on the value of Composition.section.section (Closed)
• The element 1 is sliced based on the value of Composition.section.section.section (Closed)
• The element 1 is sliced based on the value of Composition.section.section.section.section (Closed)