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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.

Usages:

• This Profile is not used by any profiles in this Specification

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
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 Required Pattern: en
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
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.
date	Σ	1..1	dateTime	Composition editing time
author	Σ	1..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the composition
title	Σ	1..1	string	Human Readable name/title
Slices for section	C	1..*	BackboneElement	Composition is broken into sections Slice: Unordered, Closed by value:code.coding.code Constraints: cmp-1, cmp-2
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:QRD-200000029850	C	1..1	BackboneElement	Composition is broken into sections Constraints: cmp-1, cmp-2
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section				Content/Rules for all slices
section:QRD-200000029851		1..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:QRD-200000029852		1..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section				Content/Rules for all slices
section:QRD-200000029853		0..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:QRD-200000029854		1..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section				Content/Rules for all slices
section:QRD-200000029855		1..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:QRD-200000029856		1..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section				Content/Rules for all slices
section:QRD-200000029857		1..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:QRD-200000029858		0..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:QRD-200000029859		0..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:QRD-200000029860		0..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Composition.language	Base	required	All Languages	📍5.0.0	FHIR Std.
Composition.status	Base	required	Composition Status	📍5.0.0	FHIR Std.
Composition.type	Base	preferred	FHIR Document Type Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029851.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section:QRD-200000029853.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section:QRD-200000029855.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029857.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029858.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029859.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029860.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.

Constraints

Id

Grade

Path(s)

Description

Expression

This structure is derived from Composition

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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
Slices for section				Content/Rules for all slices
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
Slices for section				Content/Rules for all slices
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
Slices for section				Content/Rules for all slices
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
Slices for section				Content/Rules for all slices
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    Filter: Bindings Constraints Obligations
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 Required Pattern: en
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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 Constraints: cmp-1, cmp-2
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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 Constraints: cmp-1, cmp-2
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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
Slices for section				Content/Rules for all slices
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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-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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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
Slices for section				Content/Rules for all slices
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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-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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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
Slices for section				Content/Rules for all slices
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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-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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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
Slices for section				Content/Rules for all slices
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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-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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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-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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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-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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Composition.language	Base	required	All Languages	📍5.0.0	FHIR Std.
Composition.status	Base	required	Composition Status	📍5.0.0	FHIR Std.
Composition.type	Base	preferred	FHIR Document Type Codes	📍5.0.0	FHIR Std.
Composition.category	Base	example	Referenced Item Category Value Set	📍5.0.0	FHIR Std.
Composition.attester.​mode	Base	preferred	Composition Attestation Mode	📍5.0.0	FHIR Std.
Composition.event.detail	Base	example	v3 Code System ActCode	📦3.0.0	THO v7.3
Composition.section.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029851.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029851.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029851.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029851.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029851.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029851.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section:QRD-200000029853.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section:QRD-200000029853.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section:QRD-200000029853.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section:QRD-200000029853.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section:QRD-200000029853.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section:QRD-200000029853.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section:QRD-200000029855.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section:QRD-200000029855.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section:QRD-200000029855.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section:QRD-200000029855.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section:QRD-200000029855.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section:QRD-200000029855.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029857.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029857.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029857.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029857.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029857.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029857.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029858.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029858.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029858.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029858.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029858.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029858.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029859.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029859.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029859.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029859.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029859.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029859.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029860.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029860.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029860.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029860.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029860.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029860.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.

Constraints

Id

Grade

Path(s)

Description

Expression

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    Filter: Bindings Constraints Obligations
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
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 Required Pattern: en
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
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.
date	Σ	1..1	dateTime	Composition editing time
author	Σ	1..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the composition
title	Σ	1..1	string	Human Readable name/title
Slices for section	C	1..*	BackboneElement	Composition is broken into sections Slice: Unordered, Closed by value:code.coding.code Constraints: cmp-1, cmp-2
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:QRD-200000029850	C	1..1	BackboneElement	Composition is broken into sections Constraints: cmp-1, cmp-2
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		4..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section				Content/Rules for all slices
section:QRD-200000029851		1..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:QRD-200000029852		1..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section				Content/Rules for all slices
section:QRD-200000029853		0..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:QRD-200000029854		1..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section				Content/Rules for all slices
section:QRD-200000029855		1..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:QRD-200000029856		1..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section				Content/Rules for all slices
section:QRD-200000029857		1..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:QRD-200000029858		0..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:QRD-200000029859		0..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:QRD-200000029860		0..1	BackboneElement	Nested Section
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.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section		0..*	See section (Composition)	Nested Section Slice: Unordered, Closed by value:code.coding.code
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Composition.language	Base	required	All Languages	📍5.0.0	FHIR Std.
Composition.status	Base	required	Composition Status	📍5.0.0	FHIR Std.
Composition.type	Base	preferred	FHIR Document Type Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029851.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section:QRD-200000029853.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section:QRD-200000029855.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029857.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029858.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029859.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029860.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.

Constraints

Id

Grade

Path(s)

Description

Expression

Differential View

This structure is derived from Composition

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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
Slices for section				Content/Rules for all slices
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
Slices for section				Content/Rules for all slices
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
Slices for section				Content/Rules for all slices
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
Slices for section				Content/Rules for all slices
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    Filter: Bindings Constraints Obligations
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 Required Pattern: en
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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 Constraints: cmp-1, cmp-2
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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 Constraints: cmp-1, cmp-2
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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
Slices for section				Content/Rules for all slices
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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-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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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
Slices for section				Content/Rules for all slices
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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-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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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
Slices for section				Content/Rules for all slices
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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-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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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
Slices for section				Content/Rules for all slices
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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-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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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-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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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-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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Composition.language	Base	required	All Languages	📍5.0.0	FHIR Std.
Composition.status	Base	required	Composition Status	📍5.0.0	FHIR Std.
Composition.type	Base	preferred	FHIR Document Type Codes	📍5.0.0	FHIR Std.
Composition.category	Base	example	Referenced Item Category Value Set	📍5.0.0	FHIR Std.
Composition.attester.​mode	Base	preferred	Composition Attestation Mode	📍5.0.0	FHIR Std.
Composition.event.detail	Base	example	v3 Code System ActCode	📦3.0.0	THO v7.3
Composition.section.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029851.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029851.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029851.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029851.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029851.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029851.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section:QRD-200000029853.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section:QRD-200000029853.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section:QRD-200000029853.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section:QRD-200000029853.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section:QRD-200000029853.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029852.​section:QRD-200000029853.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section:QRD-200000029855.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section:QRD-200000029855.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section:QRD-200000029855.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section:QRD-200000029855.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section:QRD-200000029855.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029854.​section:QRD-200000029855.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029857.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029857.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029857.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029857.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029857.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029857.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029858.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029858.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029858.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029858.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029858.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029858.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029859.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029859.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029859.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029859.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029859.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029856.​section:QRD-200000029859.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029860.​code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029860.​orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029860.​emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029860.​section.code	Base	example	Document Section Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029860.​section.orderedBy	Base	preferred	List Order Codes	📍5.0.0	FHIR Std.
Composition.section:QRD-200000029850.​section:QRD-200000029860.​section.emptyReason	Base	preferred	List Empty Reasons	📍5.0.0	FHIR Std.

Constraints

Id

Grade

Path(s)

Description

Expression

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)