FHIR Cross-Version Extensions package for FHIR R4B from FHIR R4
0.0.1-snapshot-2 - informative International flag

FHIR Cross-Version Extensions package for FHIR R4B from FHIR R4 - Version 0.0.1-snapshot-2. See the Directory of published versions

Extension: Cross-version Extension for R4.MedicinalProduct for use in FHIR R4B

Official URL: http://hl7.org/fhir/4.0/StructureDefinition/extension-MedicinalProduct Version: 0.0.1-snapshot-2
Standards status: Informative Maturity Level: 0 Computable Name: Ext_R4_MedicinalProduct
This cross-version extension represents MedicinalProduct from http://hl7.org/fhir/StructureDefinition/MedicinalProduct 4.0.1 for use in FHIR R4B.

Context of Use

This extension may be used on the following element(s):

  • Element ID Basic

Usage info

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Extension Content

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

This structure is derived from Extension

Summary

Simple Extension with the type base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage: This cross-version extension represents MedicinalProduct from http://hl7.org/fhir/StructureDefinition/MedicinalProduct|4.0.1 for use in FHIR R4B.

Maturity: 0

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension(4.3.0) Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)
... Slices for extension 1..* Extension Extension
Slice: Unordered, Closed by value:url
.... extension:type 0..1 Extension Regulatory type, e.g. Investigational or Authorized
..... url 1..1 uri "type"
..... value[x] 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized
.... extension:domain 0..1 Extension If this medicine applies to human or veterinary uses
..... url 1..1 uri "domain"
..... value[x] 0..1 Coding If this medicine applies to human or veterinary uses
.... extension:combinedPharmaceuticalDoseForm 0..1 Extension The dose form for a single part product, or combined form of a multiple part product
..... url 1..1 uri "combinedPharmaceuticalDoseForm"
..... value[x] 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
.... extension:legalStatusOfSupply 0..1 Extension The legal status of supply of the medicinal product as classified by the regulator
..... url 1..1 uri "legalStatusOfSupply"
..... value[x] 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator
.... extension:additionalMonitoringIndicator 0..1 Extension Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
..... url 1..1 uri "additionalMonitoringIndicator"
..... value[x] 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
.... extension:specialMeasures 0..* Extension Whether the Medicinal Product is subject to special measures for regulatory reasons
..... url 1..1 uri "specialMeasures"
..... value[x] 0..1 string Whether the Medicinal Product is subject to special measures for regulatory reasons
.... extension:paediatricUseIndicator 0..1 Extension If authorised for use in children
..... url 1..1 uri "paediatricUseIndicator"
..... value[x] 0..1 CodeableConcept If authorised for use in children
.... extension:productClassification 0..* Extension Allows the product to be classified by various systems
..... url 1..1 uri "productClassification"
..... value[x] 0..1 CodeableConcept Allows the product to be classified by various systems
.... extension:marketingStatus 0..* Extension Marketing status of the medicinal product, in contrast to marketing authorizaton
..... Slices for extension 3..* Extension Extension
Slice: Unordered, Closed by value:url
...... extension:country 1..1 Extension The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
....... url 1..1 uri "country"
....... value[x] 0..1 CodeableConcept The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
...... extension:jurisdiction 0..1 Extension Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
....... url 1..1 uri "jurisdiction"
....... value[x] 0..1 CodeableConcept Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
...... extension:status 1..1 Extension This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
....... url 1..1 uri "status"
....... value[x] 0..1 CodeableConcept This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
...... extension:dateRange 1..1 Extension The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
....... url 1..1 uri "dateRange"
....... value[x] 0..1 Period The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
...... extension:restoreDate 0..1 Extension The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
....... url 1..1 uri "restoreDate"
....... value[x] 0..1 dateTime The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
...... extension:_datatype 0..1 (Complex) Data type name for MedicinalProduct.marketingStatus from FHIR R4
URL: http://hl7.org/fhir/StructureDefinition/_datatype
....... value[x] 1..1 string Value of extension
Fixed Value: MarketingStatus
..... url 1..1 uri "marketingStatus"
.... extension:pharmaceuticalProduct 0..* Extension Pharmaceutical aspects of product
..... url 1..1 uri "pharmaceuticalProduct"
..... value[x] 0..1 Reference() Pharmaceutical aspects of product
.... extension:packagedMedicinalProduct 0..* Extension Package representation for the product
..... url 1..1 uri "packagedMedicinalProduct"
..... value[x] 0..1 Reference() Package representation for the product
.... extension:attachedDocument 0..* Extension Supporting documentation, typically for regulatory submission
..... url 1..1 uri "attachedDocument"
..... value[x] 0..1 Reference() Supporting documentation, typically for regulatory submission
.... extension:masterFile 0..* Extension A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
..... url 1..1 uri "masterFile"
..... value[x] 0..1 Reference() A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
.... extension:contact 0..* Extension A product specific contact, person (in a role), or an organization
..... url 1..1 uri "contact"
..... value[x] 0..1 Reference() A product specific contact, person (in a role), or an organization
.... extension:clinicalTrial 0..* Extension Clinical trials or studies that this product is involved in
..... url 1..1 uri "clinicalTrial"
..... value[x] 0..1 Reference() Clinical trials or studies that this product is involved in
.... extension:name 1..* Extension The product's name, including full name and possibly coded parts
..... Slices for extension 1..* Extension Extension
Slice: Unordered, Closed by value:url
...... extension:productName 1..1 Extension The full product name
....... url 1..1 uri "productName"
....... value[x] 0..1 string The full product name
...... extension:namePart 0..* Extension Coding words or phrases of the name
....... Slices for extension 2..* Extension Extension
Slice: Unordered, Closed by value:url
........ extension:part 1..1 Extension A fragment of a product name
......... url 1..1 uri "part"
......... value[x] 0..1 string A fragment of a product name
........ extension:type 1..1 Extension Idenifying type for this part of the name (e.g. strength part)
......... url 1..1 uri "type"
......... value[x] 0..1 Coding Idenifying type for this part of the name (e.g. strength part)
....... url 1..1 uri "namePart"
...... extension:countryLanguage 0..* Extension Country where the name applies
....... Slices for extension 2..* Extension Extension
Slice: Unordered, Closed by value:url
........ extension:country 1..1 Extension Country code for where this name applies
......... url 1..1 uri "country"
......... value[x] 0..1 CodeableConcept Country code for where this name applies
........ extension:jurisdiction 0..1 Extension Jurisdiction code for where this name applies
......... url 1..1 uri "jurisdiction"
......... value[x] 0..1 CodeableConcept Jurisdiction code for where this name applies
........ extension:language 1..1 Extension Language code for this name
......... url 1..1 uri "language"
......... value[x] 0..1 CodeableConcept Language code for this name
....... url 1..1 uri "countryLanguage"
..... url 1..1 uri "name"
.... extension:crossReference 0..* Extension Reference to another product, e.g. for linking authorised to investigational product
..... url 1..1 uri "crossReference"
..... value[x] 0..1 Identifier Reference to another product, e.g. for linking authorised to investigational product
.... extension:manufacturingBusinessOperation 0..* Extension An operation applied to the product, for manufacturing or adminsitrative purpose
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Closed by value:url
...... extension:operationType 0..1 Extension The type of manufacturing operation
....... url 1..1 uri "operationType"
....... value[x] 0..1 CodeableConcept The type of manufacturing operation
...... extension:authorisationReferenceNumber 0..1 Extension Regulatory authorization reference number
....... url 1..1 uri "authorisationReferenceNumber"
....... value[x] 0..1 Identifier Regulatory authorization reference number
...... extension:effectiveDate 0..1 Extension Regulatory authorization date
....... url 1..1 uri "effectiveDate"
....... value[x] 0..1 dateTime Regulatory authorization date
...... extension:confidentialityIndicator 0..1 Extension To indicate if this proces is commercially confidential
....... url 1..1 uri "confidentialityIndicator"
....... value[x] 0..1 CodeableConcept To indicate if this proces is commercially confidential
...... extension:manufacturer 0..* Extension The manufacturer or establishment associated with the process
....... url 1..1 uri "manufacturer"
....... value[x] 0..1 Reference() The manufacturer or establishment associated with the process
...... extension:regulator 0..1 Extension A regulator which oversees the operation
....... url 1..1 uri "regulator"
....... value[x] 0..1 Reference() A regulator which oversees the operation
..... url 1..1 uri "manufacturingBusinessOperation"
.... extension:specialDesignation 0..* Extension Indicates if the medicinal product has an orphan designation for the treatment of a rare disease
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Closed by value:url
...... extension:identifier 0..* Extension Identifier for the designation, or procedure number
....... url 1..1 uri "identifier"
....... value[x] 0..1 Identifier Identifier for the designation, or procedure number
...... extension:type 0..1 Extension The type of special designation, e.g. orphan drug, minor use
....... url 1..1 uri "type"
....... value[x] 0..1 CodeableConcept The type of special designation, e.g. orphan drug, minor use
...... extension:intendedUse 0..1 Extension The intended use of the product, e.g. prevention, treatment
....... url 1..1 uri "intendedUse"
....... value[x] 0..1 CodeableConcept The intended use of the product, e.g. prevention, treatment
...... extension:indication[x] 0..1 Extension Condition for which the medicinal use applies
....... url 1..1 uri "indication[x]"
....... value[x] 0..1 Condition for which the medicinal use applies
........ valueCodeableConcept CodeableConcept
........ valueReference Reference(Any)
...... extension:status 0..1 Extension For example granted, pending, expired or withdrawn
....... url 1..1 uri "status"
....... value[x] 0..1 CodeableConcept For example granted, pending, expired or withdrawn
...... extension:date 0..1 Extension Date when the designation was granted
....... url 1..1 uri "date"
....... value[x] 0..1 dateTime Date when the designation was granted
...... extension:species 0..1 Extension Animal species for which this applies
....... url 1..1 uri "species"
....... value[x] 0..1 CodeableConcept Animal species for which this applies
..... url 1..1 uri "specialDesignation"
... url 1..1 uri "http://hl7.org/fhir/4.0/StructureDefinition/extension-MedicinalProduct"

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension(4.3.0) Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)
Constraints: ext-1
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 1..* Extension Extension
Slice: Unordered, Closed by value:url
Constraints: ext-1
.... extension:type 0..1 Extension Regulatory type, e.g. Investigational or Authorized
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "type"
..... value[x] 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized
.... extension:domain 0..1 Extension If this medicine applies to human or veterinary uses
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "domain"
..... value[x] 0..1 Coding If this medicine applies to human or veterinary uses
.... extension:combinedPharmaceuticalDoseForm 0..1 Extension The dose form for a single part product, or combined form of a multiple part product
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "combinedPharmaceuticalDoseForm"
..... value[x] 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
.... extension:legalStatusOfSupply 0..1 Extension The legal status of supply of the medicinal product as classified by the regulator
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "legalStatusOfSupply"
..... value[x] 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator
.... extension:additionalMonitoringIndicator 0..1 Extension Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "additionalMonitoringIndicator"
..... value[x] 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
.... extension:specialMeasures 0..* Extension Whether the Medicinal Product is subject to special measures for regulatory reasons
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "specialMeasures"
..... value[x] 0..1 string Whether the Medicinal Product is subject to special measures for regulatory reasons
.... extension:paediatricUseIndicator 0..1 Extension If authorised for use in children
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "paediatricUseIndicator"
..... value[x] 0..1 CodeableConcept If authorised for use in children
.... extension:productClassification 0..* Extension Allows the product to be classified by various systems
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "productClassification"
..... value[x] 0..1 CodeableConcept Allows the product to be classified by various systems
.... extension:marketingStatus 0..* Extension Marketing status of the medicinal product, in contrast to marketing authorizaton
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... Slices for extension 3..* Extension Extension
Slice: Unordered, Closed by value:url
Constraints: ext-1
...... extension:country 1..1 Extension The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "country"
....... value[x] 0..1 CodeableConcept The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
...... extension:jurisdiction 0..1 Extension Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "jurisdiction"
....... value[x] 0..1 CodeableConcept Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
...... extension:status 1..1 Extension This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "status"
....... value[x] 0..1 CodeableConcept This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
...... extension:dateRange 1..1 Extension The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "dateRange"
....... value[x] 0..1 Period The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
...... extension:restoreDate 0..1 Extension The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "restoreDate"
....... value[x] 0..1 dateTime The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
...... extension:_datatype 0..1 (Complex) Data type name for MedicinalProduct.marketingStatus from FHIR R4
URL: http://hl7.org/fhir/StructureDefinition/_datatype
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..0
....... url 1..1 uri "http://hl7.org/fhir/StructureDefinition/_datatype"
....... value[x] 1..1 string Value of extension
Fixed Value: MarketingStatus
..... url 1..1 uri "marketingStatus"
..... value[x] 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueContributor Contributor
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueDosage Dosage
.... extension:pharmaceuticalProduct 0..* Extension Pharmaceutical aspects of product
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "pharmaceuticalProduct"
..... value[x] 0..1 Reference() Pharmaceutical aspects of product
.... extension:packagedMedicinalProduct 0..* Extension Package representation for the product
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "packagedMedicinalProduct"
..... value[x] 0..1 Reference() Package representation for the product
.... extension:attachedDocument 0..* Extension Supporting documentation, typically for regulatory submission
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "attachedDocument"
..... value[x] 0..1 Reference() Supporting documentation, typically for regulatory submission
.... extension:masterFile 0..* Extension A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "masterFile"
..... value[x] 0..1 Reference() A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
.... extension:contact 0..* Extension A product specific contact, person (in a role), or an organization
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "contact"
..... value[x] 0..1 Reference() A product specific contact, person (in a role), or an organization
.... extension:clinicalTrial 0..* Extension Clinical trials or studies that this product is involved in
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "clinicalTrial"
..... value[x] 0..1 Reference() Clinical trials or studies that this product is involved in
.... extension:name 1..* Extension The product's name, including full name and possibly coded parts
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... Slices for extension 1..* Extension Extension
Slice: Unordered, Closed by value:url
Constraints: ext-1
...... extension:productName 1..1 Extension The full product name
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "productName"
....... value[x] 0..1 string The full product name
...... extension:namePart 0..* Extension Coding words or phrases of the name
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... Slices for extension 2..* Extension Extension
Slice: Unordered, Closed by value:url
Constraints: ext-1
........ extension:part 1..1 Extension A fragment of a product name
Constraints: ext-1
......... id 0..1 id Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
......... url 1..1 uri "part"
......... value[x] 0..1 string A fragment of a product name
........ extension:type 1..1 Extension Idenifying type for this part of the name (e.g. strength part)
Constraints: ext-1
......... id 0..1 id Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
......... url 1..1 uri "type"
......... value[x] 0..1 Coding Idenifying type for this part of the name (e.g. strength part)
....... url 1..1 uri "namePart"
....... value[x] 0..1 Value of extension
........ valueBase64Binary base64Binary
........ valueBoolean boolean
........ valueCanonical canonical(Any)
........ valueCode code
........ valueDate date
........ valueDateTime dateTime
........ valueDecimal decimal
........ valueId id
........ valueInstant instant
........ valueInteger integer
........ valueMarkdown markdown
........ valueOid oid
........ valuePositiveInt positiveInt
........ valueString string
........ valueTime time
........ valueUnsignedInt unsignedInt
........ valueUri uri
........ valueUrl url
........ valueUuid uuid
........ valueAddress Address
........ valueAge Age
........ valueAnnotation Annotation
........ valueAttachment Attachment
........ valueCodeableConcept CodeableConcept
........ valueCodeableReference CodeableReference
........ valueCoding Coding
........ valueContactPoint ContactPoint
........ valueCount Count
........ valueDistance Distance
........ valueDuration Duration
........ valueHumanName HumanName
........ valueIdentifier Identifier
........ valueMoney Money
........ valuePeriod Period
........ valueQuantity Quantity
........ valueRange Range
........ valueRatio Ratio
........ valueRatioRange RatioRange
........ valueReference Reference(Any)
........ valueSampledData SampledData
........ valueSignature Signature
........ valueTiming Timing
........ valueContactDetail ContactDetail
........ valueContributor Contributor
........ valueDataRequirement DataRequirement
........ valueExpression Expression
........ valueParameterDefinition ParameterDefinition
........ valueRelatedArtifact RelatedArtifact
........ valueTriggerDefinition TriggerDefinition
........ valueUsageContext UsageContext
........ valueDosage Dosage
...... extension:countryLanguage 0..* Extension Country where the name applies
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... Slices for extension 2..* Extension Extension
Slice: Unordered, Closed by value:url
Constraints: ext-1
........ extension:country 1..1 Extension Country code for where this name applies
Constraints: ext-1
......... id 0..1 id Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
......... url 1..1 uri "country"
......... value[x] 0..1 CodeableConcept Country code for where this name applies
........ extension:jurisdiction 0..1 Extension Jurisdiction code for where this name applies
Constraints: ext-1
......... id 0..1 id Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
......... url 1..1 uri "jurisdiction"
......... value[x] 0..1 CodeableConcept Jurisdiction code for where this name applies
........ extension:language 1..1 Extension Language code for this name
Constraints: ext-1
......... id 0..1 id Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
......... url 1..1 uri "language"
......... value[x] 0..1 CodeableConcept Language code for this name
....... url 1..1 uri "countryLanguage"
....... value[x] 0..1 Value of extension
........ valueBase64Binary base64Binary
........ valueBoolean boolean
........ valueCanonical canonical(Any)
........ valueCode code
........ valueDate date
........ valueDateTime dateTime
........ valueDecimal decimal
........ valueId id
........ valueInstant instant
........ valueInteger integer
........ valueMarkdown markdown
........ valueOid oid
........ valuePositiveInt positiveInt
........ valueString string
........ valueTime time
........ valueUnsignedInt unsignedInt
........ valueUri uri
........ valueUrl url
........ valueUuid uuid
........ valueAddress Address
........ valueAge Age
........ valueAnnotation Annotation
........ valueAttachment Attachment
........ valueCodeableConcept CodeableConcept
........ valueCodeableReference CodeableReference
........ valueCoding Coding
........ valueContactPoint ContactPoint
........ valueCount Count
........ valueDistance Distance
........ valueDuration Duration
........ valueHumanName HumanName
........ valueIdentifier Identifier
........ valueMoney Money
........ valuePeriod Period
........ valueQuantity Quantity
........ valueRange Range
........ valueRatio Ratio
........ valueRatioRange RatioRange
........ valueReference Reference(Any)
........ valueSampledData SampledData
........ valueSignature Signature
........ valueTiming Timing
........ valueContactDetail ContactDetail
........ valueContributor Contributor
........ valueDataRequirement DataRequirement
........ valueExpression Expression
........ valueParameterDefinition ParameterDefinition
........ valueRelatedArtifact RelatedArtifact
........ valueTriggerDefinition TriggerDefinition
........ valueUsageContext UsageContext
........ valueDosage Dosage
..... url 1..1 uri "name"
..... value[x] 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueContributor Contributor
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueDosage Dosage
.... extension:crossReference 0..* Extension Reference to another product, e.g. for linking authorised to investigational product
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "crossReference"
..... value[x] 0..1 Identifier Reference to another product, e.g. for linking authorised to investigational product
.... extension:manufacturingBusinessOperation 0..* Extension An operation applied to the product, for manufacturing or adminsitrative purpose
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Closed by value:url
Constraints: ext-1
...... extension:operationType 0..1 Extension The type of manufacturing operation
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "operationType"
....... value[x] 0..1 CodeableConcept The type of manufacturing operation
...... extension:authorisationReferenceNumber 0..1 Extension Regulatory authorization reference number
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "authorisationReferenceNumber"
....... value[x] 0..1 Identifier Regulatory authorization reference number
...... extension:effectiveDate 0..1 Extension Regulatory authorization date
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "effectiveDate"
....... value[x] 0..1 dateTime Regulatory authorization date
...... extension:confidentialityIndicator 0..1 Extension To indicate if this proces is commercially confidential
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "confidentialityIndicator"
....... value[x] 0..1 CodeableConcept To indicate if this proces is commercially confidential
...... extension:manufacturer 0..* Extension The manufacturer or establishment associated with the process
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "manufacturer"
....... value[x] 0..1 Reference() The manufacturer or establishment associated with the process
...... extension:regulator 0..1 Extension A regulator which oversees the operation
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "regulator"
....... value[x] 0..1 Reference() A regulator which oversees the operation
..... url 1..1 uri "manufacturingBusinessOperation"
..... value[x] 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueContributor Contributor
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueDosage Dosage
.... extension:specialDesignation 0..* Extension Indicates if the medicinal product has an orphan designation for the treatment of a rare disease
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Closed by value:url
Constraints: ext-1
...... extension:identifier 0..* Extension Identifier for the designation, or procedure number
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "identifier"
....... value[x] 0..1 Identifier Identifier for the designation, or procedure number
...... extension:type 0..1 Extension The type of special designation, e.g. orphan drug, minor use
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "type"
....... value[x] 0..1 CodeableConcept The type of special designation, e.g. orphan drug, minor use
...... extension:intendedUse 0..1 Extension The intended use of the product, e.g. prevention, treatment
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "intendedUse"
....... value[x] 0..1 CodeableConcept The intended use of the product, e.g. prevention, treatment
...... extension:indication[x] 0..1 Extension Condition for which the medicinal use applies
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "indication[x]"
....... value[x] 0..1 Condition for which the medicinal use applies
........ valueCodeableConcept CodeableConcept
........ valueReference Reference(Any)
...... extension:status 0..1 Extension For example granted, pending, expired or withdrawn
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "status"
....... value[x] 0..1 CodeableConcept For example granted, pending, expired or withdrawn
...... extension:date 0..1 Extension Date when the designation was granted
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "date"
....... value[x] 0..1 dateTime Date when the designation was granted
...... extension:species 0..1 Extension Animal species for which this applies
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "species"
....... value[x] 0..1 CodeableConcept Animal species for which this applies
..... url 1..1 uri "specialDesignation"
..... value[x] 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueContributor Contributor
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueDosage Dosage
... url 1..1 uri "http://hl7.org/fhir/4.0/StructureDefinition/extension-MedicinalProduct"
.... valueBase64Binary base64Binary
.... valueBoolean boolean
.... valueCanonical canonical(Any)
.... valueCode code
.... valueDate date
.... valueDateTime dateTime
.... valueDecimal decimal
.... valueId id
.... valueInstant instant
.... valueInteger integer
.... valueMarkdown markdown
.... valueOid oid
.... valuePositiveInt positiveInt
.... valueString string
.... valueTime time
.... valueUnsignedInt unsignedInt
.... valueUri uri
.... valueUrl url
.... valueUuid uuid
.... valueAddress Address
.... valueAge Age
.... valueAnnotation Annotation
.... valueAttachment Attachment
.... valueCodeableConcept CodeableConcept
.... valueCodeableReference CodeableReference
.... valueCoding Coding
.... valueContactPoint ContactPoint
.... valueCount Count
.... valueDistance Distance
.... valueDuration Duration
.... valueHumanName HumanName
.... valueIdentifier Identifier
.... valueMoney Money
.... valuePeriod Period
.... valueQuantity Quantity
.... valueRange Range
.... valueRatio Ratio
.... valueRatioRange RatioRange
.... valueReference Reference(Any)
.... valueSampledData SampledData
.... valueSignature Signature
.... valueTiming Timing
.... valueContactDetail ContactDetail
.... valueContributor Contributor
.... valueDataRequirement DataRequirement
.... valueExpression Expression
.... valueParameterDefinition ParameterDefinition
.... valueRelatedArtifact RelatedArtifact
.... valueTriggerDefinition TriggerDefinition
.... valueUsageContext UsageContext
.... valueDosage Dosage

doco Documentation for this format

This structure is derived from Extension

Summary

Simple Extension with the type base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage: This cross-version extension represents MedicinalProduct from http://hl7.org/fhir/StructureDefinition/MedicinalProduct|4.0.1 for use in FHIR R4B.

Maturity: 0

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension(4.3.0) Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)
... Slices for extension 1..* Extension Extension
Slice: Unordered, Closed by value:url
.... extension:type 0..1 Extension Regulatory type, e.g. Investigational or Authorized
..... url 1..1 uri "type"
..... value[x] 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized
.... extension:domain 0..1 Extension If this medicine applies to human or veterinary uses
..... url 1..1 uri "domain"
..... value[x] 0..1 Coding If this medicine applies to human or veterinary uses
.... extension:combinedPharmaceuticalDoseForm 0..1 Extension The dose form for a single part product, or combined form of a multiple part product
..... url 1..1 uri "combinedPharmaceuticalDoseForm"
..... value[x] 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
.... extension:legalStatusOfSupply 0..1 Extension The legal status of supply of the medicinal product as classified by the regulator
..... url 1..1 uri "legalStatusOfSupply"
..... value[x] 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator
.... extension:additionalMonitoringIndicator 0..1 Extension Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
..... url 1..1 uri "additionalMonitoringIndicator"
..... value[x] 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
.... extension:specialMeasures 0..* Extension Whether the Medicinal Product is subject to special measures for regulatory reasons
..... url 1..1 uri "specialMeasures"
..... value[x] 0..1 string Whether the Medicinal Product is subject to special measures for regulatory reasons
.... extension:paediatricUseIndicator 0..1 Extension If authorised for use in children
..... url 1..1 uri "paediatricUseIndicator"
..... value[x] 0..1 CodeableConcept If authorised for use in children
.... extension:productClassification 0..* Extension Allows the product to be classified by various systems
..... url 1..1 uri "productClassification"
..... value[x] 0..1 CodeableConcept Allows the product to be classified by various systems
.... extension:marketingStatus 0..* Extension Marketing status of the medicinal product, in contrast to marketing authorizaton
..... Slices for extension 3..* Extension Extension
Slice: Unordered, Closed by value:url
...... extension:country 1..1 Extension The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
....... url 1..1 uri "country"
....... value[x] 0..1 CodeableConcept The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
...... extension:jurisdiction 0..1 Extension Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
....... url 1..1 uri "jurisdiction"
....... value[x] 0..1 CodeableConcept Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
...... extension:status 1..1 Extension This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
....... url 1..1 uri "status"
....... value[x] 0..1 CodeableConcept This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
...... extension:dateRange 1..1 Extension The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
....... url 1..1 uri "dateRange"
....... value[x] 0..1 Period The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
...... extension:restoreDate 0..1 Extension The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
....... url 1..1 uri "restoreDate"
....... value[x] 0..1 dateTime The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
...... extension:_datatype 0..1 (Complex) Data type name for MedicinalProduct.marketingStatus from FHIR R4
URL: http://hl7.org/fhir/StructureDefinition/_datatype
....... value[x] 1..1 string Value of extension
Fixed Value: MarketingStatus
..... url 1..1 uri "marketingStatus"
.... extension:pharmaceuticalProduct 0..* Extension Pharmaceutical aspects of product
..... url 1..1 uri "pharmaceuticalProduct"
..... value[x] 0..1 Reference() Pharmaceutical aspects of product
.... extension:packagedMedicinalProduct 0..* Extension Package representation for the product
..... url 1..1 uri "packagedMedicinalProduct"
..... value[x] 0..1 Reference() Package representation for the product
.... extension:attachedDocument 0..* Extension Supporting documentation, typically for regulatory submission
..... url 1..1 uri "attachedDocument"
..... value[x] 0..1 Reference() Supporting documentation, typically for regulatory submission
.... extension:masterFile 0..* Extension A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
..... url 1..1 uri "masterFile"
..... value[x] 0..1 Reference() A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
.... extension:contact 0..* Extension A product specific contact, person (in a role), or an organization
..... url 1..1 uri "contact"
..... value[x] 0..1 Reference() A product specific contact, person (in a role), or an organization
.... extension:clinicalTrial 0..* Extension Clinical trials or studies that this product is involved in
..... url 1..1 uri "clinicalTrial"
..... value[x] 0..1 Reference() Clinical trials or studies that this product is involved in
.... extension:name 1..* Extension The product's name, including full name and possibly coded parts
..... Slices for extension 1..* Extension Extension
Slice: Unordered, Closed by value:url
...... extension:productName 1..1 Extension The full product name
....... url 1..1 uri "productName"
....... value[x] 0..1 string The full product name
...... extension:namePart 0..* Extension Coding words or phrases of the name
....... Slices for extension 2..* Extension Extension
Slice: Unordered, Closed by value:url
........ extension:part 1..1 Extension A fragment of a product name
......... url 1..1 uri "part"
......... value[x] 0..1 string A fragment of a product name
........ extension:type 1..1 Extension Idenifying type for this part of the name (e.g. strength part)
......... url 1..1 uri "type"
......... value[x] 0..1 Coding Idenifying type for this part of the name (e.g. strength part)
....... url 1..1 uri "namePart"
...... extension:countryLanguage 0..* Extension Country where the name applies
....... Slices for extension 2..* Extension Extension
Slice: Unordered, Closed by value:url
........ extension:country 1..1 Extension Country code for where this name applies
......... url 1..1 uri "country"
......... value[x] 0..1 CodeableConcept Country code for where this name applies
........ extension:jurisdiction 0..1 Extension Jurisdiction code for where this name applies
......... url 1..1 uri "jurisdiction"
......... value[x] 0..1 CodeableConcept Jurisdiction code for where this name applies
........ extension:language 1..1 Extension Language code for this name
......... url 1..1 uri "language"
......... value[x] 0..1 CodeableConcept Language code for this name
....... url 1..1 uri "countryLanguage"
..... url 1..1 uri "name"
.... extension:crossReference 0..* Extension Reference to another product, e.g. for linking authorised to investigational product
..... url 1..1 uri "crossReference"
..... value[x] 0..1 Identifier Reference to another product, e.g. for linking authorised to investigational product
.... extension:manufacturingBusinessOperation 0..* Extension An operation applied to the product, for manufacturing or adminsitrative purpose
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Closed by value:url
...... extension:operationType 0..1 Extension The type of manufacturing operation
....... url 1..1 uri "operationType"
....... value[x] 0..1 CodeableConcept The type of manufacturing operation
...... extension:authorisationReferenceNumber 0..1 Extension Regulatory authorization reference number
....... url 1..1 uri "authorisationReferenceNumber"
....... value[x] 0..1 Identifier Regulatory authorization reference number
...... extension:effectiveDate 0..1 Extension Regulatory authorization date
....... url 1..1 uri "effectiveDate"
....... value[x] 0..1 dateTime Regulatory authorization date
...... extension:confidentialityIndicator 0..1 Extension To indicate if this proces is commercially confidential
....... url 1..1 uri "confidentialityIndicator"
....... value[x] 0..1 CodeableConcept To indicate if this proces is commercially confidential
...... extension:manufacturer 0..* Extension The manufacturer or establishment associated with the process
....... url 1..1 uri "manufacturer"
....... value[x] 0..1 Reference() The manufacturer or establishment associated with the process
...... extension:regulator 0..1 Extension A regulator which oversees the operation
....... url 1..1 uri "regulator"
....... value[x] 0..1 Reference() A regulator which oversees the operation
..... url 1..1 uri "manufacturingBusinessOperation"
.... extension:specialDesignation 0..* Extension Indicates if the medicinal product has an orphan designation for the treatment of a rare disease
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Closed by value:url
...... extension:identifier 0..* Extension Identifier for the designation, or procedure number
....... url 1..1 uri "identifier"
....... value[x] 0..1 Identifier Identifier for the designation, or procedure number
...... extension:type 0..1 Extension The type of special designation, e.g. orphan drug, minor use
....... url 1..1 uri "type"
....... value[x] 0..1 CodeableConcept The type of special designation, e.g. orphan drug, minor use
...... extension:intendedUse 0..1 Extension The intended use of the product, e.g. prevention, treatment
....... url 1..1 uri "intendedUse"
....... value[x] 0..1 CodeableConcept The intended use of the product, e.g. prevention, treatment
...... extension:indication[x] 0..1 Extension Condition for which the medicinal use applies
....... url 1..1 uri "indication[x]"
....... value[x] 0..1 Condition for which the medicinal use applies
........ valueCodeableConcept CodeableConcept
........ valueReference Reference(Any)
...... extension:status 0..1 Extension For example granted, pending, expired or withdrawn
....... url 1..1 uri "status"
....... value[x] 0..1 CodeableConcept For example granted, pending, expired or withdrawn
...... extension:date 0..1 Extension Date when the designation was granted
....... url 1..1 uri "date"
....... value[x] 0..1 dateTime Date when the designation was granted
...... extension:species 0..1 Extension Animal species for which this applies
....... url 1..1 uri "species"
....... value[x] 0..1 CodeableConcept Animal species for which this applies
..... url 1..1 uri "specialDesignation"
... url 1..1 uri "http://hl7.org/fhir/4.0/StructureDefinition/extension-MedicinalProduct"

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension(4.3.0) Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)
Constraints: ext-1
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 1..* Extension Extension
Slice: Unordered, Closed by value:url
Constraints: ext-1
.... extension:type 0..1 Extension Regulatory type, e.g. Investigational or Authorized
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "type"
..... value[x] 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized
.... extension:domain 0..1 Extension If this medicine applies to human or veterinary uses
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "domain"
..... value[x] 0..1 Coding If this medicine applies to human or veterinary uses
.... extension:combinedPharmaceuticalDoseForm 0..1 Extension The dose form for a single part product, or combined form of a multiple part product
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "combinedPharmaceuticalDoseForm"
..... value[x] 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
.... extension:legalStatusOfSupply 0..1 Extension The legal status of supply of the medicinal product as classified by the regulator
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "legalStatusOfSupply"
..... value[x] 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator
.... extension:additionalMonitoringIndicator 0..1 Extension Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "additionalMonitoringIndicator"
..... value[x] 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
.... extension:specialMeasures 0..* Extension Whether the Medicinal Product is subject to special measures for regulatory reasons
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "specialMeasures"
..... value[x] 0..1 string Whether the Medicinal Product is subject to special measures for regulatory reasons
.... extension:paediatricUseIndicator 0..1 Extension If authorised for use in children
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "paediatricUseIndicator"
..... value[x] 0..1 CodeableConcept If authorised for use in children
.... extension:productClassification 0..* Extension Allows the product to be classified by various systems
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "productClassification"
..... value[x] 0..1 CodeableConcept Allows the product to be classified by various systems
.... extension:marketingStatus 0..* Extension Marketing status of the medicinal product, in contrast to marketing authorizaton
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... Slices for extension 3..* Extension Extension
Slice: Unordered, Closed by value:url
Constraints: ext-1
...... extension:country 1..1 Extension The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "country"
....... value[x] 0..1 CodeableConcept The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
...... extension:jurisdiction 0..1 Extension Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "jurisdiction"
....... value[x] 0..1 CodeableConcept Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
...... extension:status 1..1 Extension This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "status"
....... value[x] 0..1 CodeableConcept This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
...... extension:dateRange 1..1 Extension The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "dateRange"
....... value[x] 0..1 Period The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
...... extension:restoreDate 0..1 Extension The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "restoreDate"
....... value[x] 0..1 dateTime The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
...... extension:_datatype 0..1 (Complex) Data type name for MedicinalProduct.marketingStatus from FHIR R4
URL: http://hl7.org/fhir/StructureDefinition/_datatype
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..0
....... url 1..1 uri "http://hl7.org/fhir/StructureDefinition/_datatype"
....... value[x] 1..1 string Value of extension
Fixed Value: MarketingStatus
..... url 1..1 uri "marketingStatus"
..... value[x] 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueContributor Contributor
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueDosage Dosage
.... extension:pharmaceuticalProduct 0..* Extension Pharmaceutical aspects of product
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "pharmaceuticalProduct"
..... value[x] 0..1 Reference() Pharmaceutical aspects of product
.... extension:packagedMedicinalProduct 0..* Extension Package representation for the product
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "packagedMedicinalProduct"
..... value[x] 0..1 Reference() Package representation for the product
.... extension:attachedDocument 0..* Extension Supporting documentation, typically for regulatory submission
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "attachedDocument"
..... value[x] 0..1 Reference() Supporting documentation, typically for regulatory submission
.... extension:masterFile 0..* Extension A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "masterFile"
..... value[x] 0..1 Reference() A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
.... extension:contact 0..* Extension A product specific contact, person (in a role), or an organization
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "contact"
..... value[x] 0..1 Reference() A product specific contact, person (in a role), or an organization
.... extension:clinicalTrial 0..* Extension Clinical trials or studies that this product is involved in
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "clinicalTrial"
..... value[x] 0..1 Reference() Clinical trials or studies that this product is involved in
.... extension:name 1..* Extension The product's name, including full name and possibly coded parts
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... Slices for extension 1..* Extension Extension
Slice: Unordered, Closed by value:url
Constraints: ext-1
...... extension:productName 1..1 Extension The full product name
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "productName"
....... value[x] 0..1 string The full product name
...... extension:namePart 0..* Extension Coding words or phrases of the name
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... Slices for extension 2..* Extension Extension
Slice: Unordered, Closed by value:url
Constraints: ext-1
........ extension:part 1..1 Extension A fragment of a product name
Constraints: ext-1
......... id 0..1 id Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
......... url 1..1 uri "part"
......... value[x] 0..1 string A fragment of a product name
........ extension:type 1..1 Extension Idenifying type for this part of the name (e.g. strength part)
Constraints: ext-1
......... id 0..1 id Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
......... url 1..1 uri "type"
......... value[x] 0..1 Coding Idenifying type for this part of the name (e.g. strength part)
....... url 1..1 uri "namePart"
....... value[x] 0..1 Value of extension
........ valueBase64Binary base64Binary
........ valueBoolean boolean
........ valueCanonical canonical(Any)
........ valueCode code
........ valueDate date
........ valueDateTime dateTime
........ valueDecimal decimal
........ valueId id
........ valueInstant instant
........ valueInteger integer
........ valueMarkdown markdown
........ valueOid oid
........ valuePositiveInt positiveInt
........ valueString string
........ valueTime time
........ valueUnsignedInt unsignedInt
........ valueUri uri
........ valueUrl url
........ valueUuid uuid
........ valueAddress Address
........ valueAge Age
........ valueAnnotation Annotation
........ valueAttachment Attachment
........ valueCodeableConcept CodeableConcept
........ valueCodeableReference CodeableReference
........ valueCoding Coding
........ valueContactPoint ContactPoint
........ valueCount Count
........ valueDistance Distance
........ valueDuration Duration
........ valueHumanName HumanName
........ valueIdentifier Identifier
........ valueMoney Money
........ valuePeriod Period
........ valueQuantity Quantity
........ valueRange Range
........ valueRatio Ratio
........ valueRatioRange RatioRange
........ valueReference Reference(Any)
........ valueSampledData SampledData
........ valueSignature Signature
........ valueTiming Timing
........ valueContactDetail ContactDetail
........ valueContributor Contributor
........ valueDataRequirement DataRequirement
........ valueExpression Expression
........ valueParameterDefinition ParameterDefinition
........ valueRelatedArtifact RelatedArtifact
........ valueTriggerDefinition TriggerDefinition
........ valueUsageContext UsageContext
........ valueDosage Dosage
...... extension:countryLanguage 0..* Extension Country where the name applies
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... Slices for extension 2..* Extension Extension
Slice: Unordered, Closed by value:url
Constraints: ext-1
........ extension:country 1..1 Extension Country code for where this name applies
Constraints: ext-1
......... id 0..1 id Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
......... url 1..1 uri "country"
......... value[x] 0..1 CodeableConcept Country code for where this name applies
........ extension:jurisdiction 0..1 Extension Jurisdiction code for where this name applies
Constraints: ext-1
......... id 0..1 id Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
......... url 1..1 uri "jurisdiction"
......... value[x] 0..1 CodeableConcept Jurisdiction code for where this name applies
........ extension:language 1..1 Extension Language code for this name
Constraints: ext-1
......... id 0..1 id Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
......... url 1..1 uri "language"
......... value[x] 0..1 CodeableConcept Language code for this name
....... url 1..1 uri "countryLanguage"
....... value[x] 0..1 Value of extension
........ valueBase64Binary base64Binary
........ valueBoolean boolean
........ valueCanonical canonical(Any)
........ valueCode code
........ valueDate date
........ valueDateTime dateTime
........ valueDecimal decimal
........ valueId id
........ valueInstant instant
........ valueInteger integer
........ valueMarkdown markdown
........ valueOid oid
........ valuePositiveInt positiveInt
........ valueString string
........ valueTime time
........ valueUnsignedInt unsignedInt
........ valueUri uri
........ valueUrl url
........ valueUuid uuid
........ valueAddress Address
........ valueAge Age
........ valueAnnotation Annotation
........ valueAttachment Attachment
........ valueCodeableConcept CodeableConcept
........ valueCodeableReference CodeableReference
........ valueCoding Coding
........ valueContactPoint ContactPoint
........ valueCount Count
........ valueDistance Distance
........ valueDuration Duration
........ valueHumanName HumanName
........ valueIdentifier Identifier
........ valueMoney Money
........ valuePeriod Period
........ valueQuantity Quantity
........ valueRange Range
........ valueRatio Ratio
........ valueRatioRange RatioRange
........ valueReference Reference(Any)
........ valueSampledData SampledData
........ valueSignature Signature
........ valueTiming Timing
........ valueContactDetail ContactDetail
........ valueContributor Contributor
........ valueDataRequirement DataRequirement
........ valueExpression Expression
........ valueParameterDefinition ParameterDefinition
........ valueRelatedArtifact RelatedArtifact
........ valueTriggerDefinition TriggerDefinition
........ valueUsageContext UsageContext
........ valueDosage Dosage
..... url 1..1 uri "name"
..... value[x] 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueContributor Contributor
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueDosage Dosage
.... extension:crossReference 0..* Extension Reference to another product, e.g. for linking authorised to investigational product
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
..... url 1..1 uri "crossReference"
..... value[x] 0..1 Identifier Reference to another product, e.g. for linking authorised to investigational product
.... extension:manufacturingBusinessOperation 0..* Extension An operation applied to the product, for manufacturing or adminsitrative purpose
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Closed by value:url
Constraints: ext-1
...... extension:operationType 0..1 Extension The type of manufacturing operation
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "operationType"
....... value[x] 0..1 CodeableConcept The type of manufacturing operation
...... extension:authorisationReferenceNumber 0..1 Extension Regulatory authorization reference number
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "authorisationReferenceNumber"
....... value[x] 0..1 Identifier Regulatory authorization reference number
...... extension:effectiveDate 0..1 Extension Regulatory authorization date
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "effectiveDate"
....... value[x] 0..1 dateTime Regulatory authorization date
...... extension:confidentialityIndicator 0..1 Extension To indicate if this proces is commercially confidential
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "confidentialityIndicator"
....... value[x] 0..1 CodeableConcept To indicate if this proces is commercially confidential
...... extension:manufacturer 0..* Extension The manufacturer or establishment associated with the process
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "manufacturer"
....... value[x] 0..1 Reference() The manufacturer or establishment associated with the process
...... extension:regulator 0..1 Extension A regulator which oversees the operation
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "regulator"
....... value[x] 0..1 Reference() A regulator which oversees the operation
..... url 1..1 uri "manufacturingBusinessOperation"
..... value[x] 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueContributor Contributor
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueDosage Dosage
.... extension:specialDesignation 0..* Extension Indicates if the medicinal product has an orphan designation for the treatment of a rare disease
Constraints: ext-1
..... id 0..1 id Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Closed by value:url
Constraints: ext-1
...... extension:identifier 0..* Extension Identifier for the designation, or procedure number
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "identifier"
....... value[x] 0..1 Identifier Identifier for the designation, or procedure number
...... extension:type 0..1 Extension The type of special designation, e.g. orphan drug, minor use
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "type"
....... value[x] 0..1 CodeableConcept The type of special designation, e.g. orphan drug, minor use
...... extension:intendedUse 0..1 Extension The intended use of the product, e.g. prevention, treatment
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "intendedUse"
....... value[x] 0..1 CodeableConcept The intended use of the product, e.g. prevention, treatment
...... extension:indication[x] 0..1 Extension Condition for which the medicinal use applies
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "indication[x]"
....... value[x] 0..1 Condition for which the medicinal use applies
........ valueCodeableConcept CodeableConcept
........ valueReference Reference(Any)
...... extension:status 0..1 Extension For example granted, pending, expired or withdrawn
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "status"
....... value[x] 0..1 CodeableConcept For example granted, pending, expired or withdrawn
...... extension:date 0..1 Extension Date when the designation was granted
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "date"
....... value[x] 0..1 dateTime Date when the designation was granted
...... extension:species 0..1 Extension Animal species for which this applies
Constraints: ext-1
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1
....... url 1..1 uri "species"
....... value[x] 0..1 CodeableConcept Animal species for which this applies
..... url 1..1 uri "specialDesignation"
..... value[x] 0..1 Value of extension
...... valueBase64Binary base64Binary
...... valueBoolean boolean
...... valueCanonical canonical(Any)
...... valueCode code
...... valueDate date
...... valueDateTime dateTime
...... valueDecimal decimal
...... valueId id
...... valueInstant instant
...... valueInteger integer
...... valueMarkdown markdown
...... valueOid oid
...... valuePositiveInt positiveInt
...... valueString string
...... valueTime time
...... valueUnsignedInt unsignedInt
...... valueUri uri
...... valueUrl url
...... valueUuid uuid
...... valueAddress Address
...... valueAge Age
...... valueAnnotation Annotation
...... valueAttachment Attachment
...... valueCodeableConcept CodeableConcept
...... valueCodeableReference CodeableReference
...... valueCoding Coding
...... valueContactPoint ContactPoint
...... valueCount Count
...... valueDistance Distance
...... valueDuration Duration
...... valueHumanName HumanName
...... valueIdentifier Identifier
...... valueMoney Money
...... valuePeriod Period
...... valueQuantity Quantity
...... valueRange Range
...... valueRatio Ratio
...... valueRatioRange RatioRange
...... valueReference Reference(Any)
...... valueSampledData SampledData
...... valueSignature Signature
...... valueTiming Timing
...... valueContactDetail ContactDetail
...... valueContributor Contributor
...... valueDataRequirement DataRequirement
...... valueExpression Expression
...... valueParameterDefinition ParameterDefinition
...... valueRelatedArtifact RelatedArtifact
...... valueTriggerDefinition TriggerDefinition
...... valueUsageContext UsageContext
...... valueDosage Dosage
... url 1..1 uri "http://hl7.org/fhir/4.0/StructureDefinition/extension-MedicinalProduct"
.... valueBase64Binary base64Binary
.... valueBoolean boolean
.... valueCanonical canonical(Any)
.... valueCode code
.... valueDate date
.... valueDateTime dateTime
.... valueDecimal decimal
.... valueId id
.... valueInstant instant
.... valueInteger integer
.... valueMarkdown markdown
.... valueOid oid
.... valuePositiveInt positiveInt
.... valueString string
.... valueTime time
.... valueUnsignedInt unsignedInt
.... valueUri uri
.... valueUrl url
.... valueUuid uuid
.... valueAddress Address
.... valueAge Age
.... valueAnnotation Annotation
.... valueAttachment Attachment
.... valueCodeableConcept CodeableConcept
.... valueCodeableReference CodeableReference
.... valueCoding Coding
.... valueContactPoint ContactPoint
.... valueCount Count
.... valueDistance Distance
.... valueDuration Duration
.... valueHumanName HumanName
.... valueIdentifier Identifier
.... valueMoney Money
.... valuePeriod Period
.... valueQuantity Quantity
.... valueRange Range
.... valueRatio Ratio
.... valueRatioRange RatioRange
.... valueReference Reference(Any)
.... valueSampledData SampledData
.... valueSignature Signature
.... valueTiming Timing
.... valueContactDetail ContactDetail
.... valueContributor Contributor
.... valueDataRequirement DataRequirement
.... valueExpression Expression
.... valueParameterDefinition ParameterDefinition
.... valueRelatedArtifact RelatedArtifact
.... valueTriggerDefinition TriggerDefinition
.... valueUsageContext UsageContext
.... valueDosage Dosage

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Constraints

IdGradePath(s)DetailsRequirements
ele-1errorExtension, Extension.extension, Extension.extension:type, Extension.extension:type.extension, Extension.extension:type.value[x], Extension.extension:domain, Extension.extension:domain.extension, Extension.extension:domain.value[x], Extension.extension:combinedPharmaceuticalDoseForm, Extension.extension:combinedPharmaceuticalDoseForm.extension, Extension.extension:combinedPharmaceuticalDoseForm.value[x], Extension.extension:legalStatusOfSupply, Extension.extension:legalStatusOfSupply.extension, Extension.extension:legalStatusOfSupply.value[x], Extension.extension:additionalMonitoringIndicator, Extension.extension:additionalMonitoringIndicator.extension, Extension.extension:additionalMonitoringIndicator.value[x], Extension.extension:specialMeasures, Extension.extension:specialMeasures.extension, Extension.extension:specialMeasures.value[x], Extension.extension:paediatricUseIndicator, Extension.extension:paediatricUseIndicator.extension, Extension.extension:paediatricUseIndicator.value[x], Extension.extension:productClassification, Extension.extension:productClassification.extension, Extension.extension:productClassification.value[x], Extension.extension:marketingStatus, Extension.extension:marketingStatus.extension, Extension.extension:marketingStatus.extension:country, Extension.extension:marketingStatus.extension:country.extension, Extension.extension:marketingStatus.extension:country.value[x], Extension.extension:marketingStatus.extension:jurisdiction, Extension.extension:marketingStatus.extension:jurisdiction.extension, Extension.extension:marketingStatus.extension:jurisdiction.value[x], Extension.extension:marketingStatus.extension:status, Extension.extension:marketingStatus.extension:status.extension, Extension.extension:marketingStatus.extension:status.value[x], Extension.extension:marketingStatus.extension:dateRange, Extension.extension:marketingStatus.extension:dateRange.extension, Extension.extension:marketingStatus.extension:dateRange.value[x], Extension.extension:marketingStatus.extension:restoreDate, Extension.extension:marketingStatus.extension:restoreDate.extension, Extension.extension:marketingStatus.extension:restoreDate.value[x], Extension.extension:marketingStatus.extension:_datatype, Extension.extension:marketingStatus.extension:_datatype.value[x], Extension.extension:marketingStatus.value[x], Extension.extension:pharmaceuticalProduct, Extension.extension:pharmaceuticalProduct.extension, Extension.extension:pharmaceuticalProduct.value[x], Extension.extension:packagedMedicinalProduct, Extension.extension:packagedMedicinalProduct.extension, Extension.extension:packagedMedicinalProduct.value[x], Extension.extension:attachedDocument, Extension.extension:attachedDocument.extension, Extension.extension:attachedDocument.value[x], Extension.extension:masterFile, Extension.extension:masterFile.extension, Extension.extension:masterFile.value[x], Extension.extension:contact, Extension.extension:contact.extension, Extension.extension:contact.value[x], Extension.extension:clinicalTrial, Extension.extension:clinicalTrial.extension, Extension.extension:clinicalTrial.value[x], Extension.extension:name, Extension.extension:name.extension, Extension.extension:name.extension:productName, Extension.extension:name.extension:productName.extension, Extension.extension:name.extension:productName.value[x], Extension.extension:name.extension:namePart, Extension.extension:name.extension:namePart.extension, Extension.extension:name.extension:namePart.extension:part, Extension.extension:name.extension:namePart.extension:part.extension, Extension.extension:name.extension:namePart.extension:part.value[x], Extension.extension:name.extension:namePart.extension:type, Extension.extension:name.extension:namePart.extension:type.extension, Extension.extension:name.extension:namePart.extension:type.value[x], Extension.extension:name.extension:namePart.value[x], Extension.extension:name.extension:countryLanguage, Extension.extension:name.extension:countryLanguage.extension, Extension.extension:name.extension:countryLanguage.extension:country, Extension.extension:name.extension:countryLanguage.extension:country.extension, Extension.extension:name.extension:countryLanguage.extension:country.value[x], Extension.extension:name.extension:countryLanguage.extension:jurisdiction, Extension.extension:name.extension:countryLanguage.extension:jurisdiction.extension, Extension.extension:name.extension:countryLanguage.extension:jurisdiction.value[x], Extension.extension:name.extension:countryLanguage.extension:language, Extension.extension:name.extension:countryLanguage.extension:language.extension, Extension.extension:name.extension:countryLanguage.extension:language.value[x], Extension.extension:name.extension:countryLanguage.value[x], Extension.extension:name.value[x], Extension.extension:crossReference, Extension.extension:crossReference.extension, Extension.extension:crossReference.value[x], Extension.extension:manufacturingBusinessOperation, Extension.extension:manufacturingBusinessOperation.extension, Extension.extension:manufacturingBusinessOperation.extension:operationType, Extension.extension:manufacturingBusinessOperation.extension:operationType.extension, Extension.extension:manufacturingBusinessOperation.extension:operationType.value[x], Extension.extension:manufacturingBusinessOperation.extension:authorisationReferenceNumber, Extension.extension:manufacturingBusinessOperation.extension:authorisationReferenceNumber.extension, Extension.extension:manufacturingBusinessOperation.extension:authorisationReferenceNumber.value[x], Extension.extension:manufacturingBusinessOperation.extension:effectiveDate, Extension.extension:manufacturingBusinessOperation.extension:effectiveDate.extension, Extension.extension:manufacturingBusinessOperation.extension:effectiveDate.value[x], Extension.extension:manufacturingBusinessOperation.extension:confidentialityIndicator, Extension.extension:manufacturingBusinessOperation.extension:confidentialityIndicator.extension, Extension.extension:manufacturingBusinessOperation.extension:confidentialityIndicator.value[x], Extension.extension:manufacturingBusinessOperation.extension:manufacturer, Extension.extension:manufacturingBusinessOperation.extension:manufacturer.extension, Extension.extension:manufacturingBusinessOperation.extension:manufacturer.value[x], Extension.extension:manufacturingBusinessOperation.extension:regulator, Extension.extension:manufacturingBusinessOperation.extension:regulator.extension, Extension.extension:manufacturingBusinessOperation.extension:regulator.value[x], Extension.extension:manufacturingBusinessOperation.value[x], Extension.extension:specialDesignation, Extension.extension:specialDesignation.extension, Extension.extension:specialDesignation.extension:identifier, Extension.extension:specialDesignation.extension:identifier.extension, Extension.extension:specialDesignation.extension:identifier.value[x], Extension.extension:specialDesignation.extension:type, Extension.extension:specialDesignation.extension:type.extension, Extension.extension:specialDesignation.extension:type.value[x], Extension.extension:specialDesignation.extension:intendedUse, Extension.extension:specialDesignation.extension:intendedUse.extension, Extension.extension:specialDesignation.extension:intendedUse.value[x], Extension.extension:specialDesignation.extension:indication[x], Extension.extension:specialDesignation.extension:indication[x].extension, Extension.extension:specialDesignation.extension:indication[x].value[x], Extension.extension:specialDesignation.extension:status, Extension.extension:specialDesignation.extension:status.extension, Extension.extension:specialDesignation.extension:status.value[x], Extension.extension:specialDesignation.extension:date, Extension.extension:specialDesignation.extension:date.extension, Extension.extension:specialDesignation.extension:date.value[x], Extension.extension:specialDesignation.extension:species, Extension.extension:specialDesignation.extension:species.extension, Extension.extension:specialDesignation.extension:species.value[x], Extension.extension:specialDesignation.value[x], Extension.value[x]All FHIR elements must have a @value or children unless an empty Parameters resource
: hasValue() or (children().count() > id.count()) or $this is Parameters
ext-1errorExtension, Extension.extension, Extension.extension:type, Extension.extension:type.extension, Extension.extension:domain, Extension.extension:domain.extension, Extension.extension:combinedPharmaceuticalDoseForm, Extension.extension:combinedPharmaceuticalDoseForm.extension, Extension.extension:legalStatusOfSupply, Extension.extension:legalStatusOfSupply.extension, Extension.extension:additionalMonitoringIndicator, Extension.extension:additionalMonitoringIndicator.extension, Extension.extension:specialMeasures, Extension.extension:specialMeasures.extension, Extension.extension:paediatricUseIndicator, Extension.extension:paediatricUseIndicator.extension, Extension.extension:productClassification, Extension.extension:productClassification.extension, Extension.extension:marketingStatus, Extension.extension:marketingStatus.extension, Extension.extension:marketingStatus.extension:country, Extension.extension:marketingStatus.extension:country.extension, Extension.extension:marketingStatus.extension:jurisdiction, Extension.extension:marketingStatus.extension:jurisdiction.extension, Extension.extension:marketingStatus.extension:status, Extension.extension:marketingStatus.extension:status.extension, Extension.extension:marketingStatus.extension:dateRange, Extension.extension:marketingStatus.extension:dateRange.extension, Extension.extension:marketingStatus.extension:restoreDate, Extension.extension:marketingStatus.extension:restoreDate.extension, Extension.extension:marketingStatus.extension:_datatype, Extension.extension:pharmaceuticalProduct, Extension.extension:pharmaceuticalProduct.extension, Extension.extension:packagedMedicinalProduct, Extension.extension:packagedMedicinalProduct.extension, Extension.extension:attachedDocument, Extension.extension:attachedDocument.extension, Extension.extension:masterFile, Extension.extension:masterFile.extension, Extension.extension:contact, Extension.extension:contact.extension, Extension.extension:clinicalTrial, Extension.extension:clinicalTrial.extension, Extension.extension:name, Extension.extension:name.extension, Extension.extension:name.extension:productName, Extension.extension:name.extension:productName.extension, Extension.extension:name.extension:namePart, Extension.extension:name.extension:namePart.extension, Extension.extension:name.extension:namePart.extension:part, Extension.extension:name.extension:namePart.extension:part.extension, Extension.extension:name.extension:namePart.extension:type, Extension.extension:name.extension:namePart.extension:type.extension, Extension.extension:name.extension:countryLanguage, Extension.extension:name.extension:countryLanguage.extension, Extension.extension:name.extension:countryLanguage.extension:country, Extension.extension:name.extension:countryLanguage.extension:country.extension, Extension.extension:name.extension:countryLanguage.extension:jurisdiction, Extension.extension:name.extension:countryLanguage.extension:jurisdiction.extension, Extension.extension:name.extension:countryLanguage.extension:language, Extension.extension:name.extension:countryLanguage.extension:language.extension, Extension.extension:crossReference, Extension.extension:crossReference.extension, Extension.extension:manufacturingBusinessOperation, Extension.extension:manufacturingBusinessOperation.extension, Extension.extension:manufacturingBusinessOperation.extension:operationType, Extension.extension:manufacturingBusinessOperation.extension:operationType.extension, Extension.extension:manufacturingBusinessOperation.extension:authorisationReferenceNumber, Extension.extension:manufacturingBusinessOperation.extension:authorisationReferenceNumber.extension, Extension.extension:manufacturingBusinessOperation.extension:effectiveDate, Extension.extension:manufacturingBusinessOperation.extension:effectiveDate.extension, Extension.extension:manufacturingBusinessOperation.extension:confidentialityIndicator, Extension.extension:manufacturingBusinessOperation.extension:confidentialityIndicator.extension, Extension.extension:manufacturingBusinessOperation.extension:manufacturer, Extension.extension:manufacturingBusinessOperation.extension:manufacturer.extension, Extension.extension:manufacturingBusinessOperation.extension:regulator, Extension.extension:manufacturingBusinessOperation.extension:regulator.extension, Extension.extension:specialDesignation, Extension.extension:specialDesignation.extension, Extension.extension:specialDesignation.extension:identifier, Extension.extension:specialDesignation.extension:identifier.extension, Extension.extension:specialDesignation.extension:type, Extension.extension:specialDesignation.extension:type.extension, Extension.extension:specialDesignation.extension:intendedUse, Extension.extension:specialDesignation.extension:intendedUse.extension, Extension.extension:specialDesignation.extension:indication[x], Extension.extension:specialDesignation.extension:indication[x].extension, Extension.extension:specialDesignation.extension:status, Extension.extension:specialDesignation.extension:status.extension, Extension.extension:specialDesignation.extension:date, Extension.extension:specialDesignation.extension:date.extension, Extension.extension:specialDesignation.extension:species, Extension.extension:specialDesignation.extension:species.extensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()