Release 5 FHIR CI-Build

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15.15.0 15.10.0 MarketingStatus

Maturity Level : 3
Responsible Owner: Pharmacy icon Work Group Standards Status : Trial Use

Types Framework Cross Reference: Base Types | Datatypes | Resources | Patterns

The MarketingStatus structure allows specifying that an item or product is on the market for sale, or that it is not available, and the dates associated. This refers to a marketing choice rather than having permission, and so is a different concept to it being approved, cleared or licenced to be on sale (for which see RegulatedAuthorization ).

Note: the MarketingStatus structure allows modifier extensions .

Structure

Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology
Name Flags Card. Type Description & Constraints      Filter: Filters doco
. . MarketingStatus Σ D N Element The marketing status describes the date when a medicinal product an item is actually put on the market or the date as of which it is no longer available

Elements defined in Ancestors: id , extension , modifierExtension
. . . country Σ 0..1 CodeableConcept The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements status applies
. . . jurisdiction Σ 0..1 CodeableConcept The controlled term and jurisdiction in which the controlled term identifier shall be specified marketing status applies
. . . status Σ 1..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 item
. . . restoreDate Σ 0..1 dateTime The date when the Medicinal Product item is due to be placed back on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in owner, manufacturer or distributor, after 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 suspension

doco Documentation for this format icon

Definition: XML | JSON

UML Diagram ( Legend )

MarketingStatus The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements status applies country : CodeableConcept [0..1] Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and jurisdiction in which the controlled term identifier shall be specified marketing status applies jurisdiction : CodeableConcept [0..1] This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples item status : CodeableConcept [1..1] The date when dates that the Medicinal Product item is placed made available on the market by the Marketing Authorization Holder owner (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 jurisdiction. Note that “on the market” refers to the release of the Medicinal Product item into the distribution chain dateRange : Period [0..1] The date when the Medicinal Product item is due to be placed back on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in owner, manufacturer or distributor, after 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 suspension restoreDate : dateTime [0..1] BackboneType May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself) (this element modifies the meaning of other elements) modifierExtension : Extension [0..*]

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .

[
 # from Element: 
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:

 # from Element: fhir:extension
  fhir:country [ CodeableConcept ] ; # 0..1 The country in which the marketing status applies
  fhir:jurisdiction [ CodeableConcept ] ; # 0..1 The jurisdiction in which the marketing status applies
  fhir:status [ CodeableConcept ] ; # 1..1 This attribute provides information on the status of the marketing of the item
  fhir:dateRange [ Period ] ; # 0..1 The dates that the item is made available on the market by the owner (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction. Note that “on the market” refers to the release of the item into the distribution chain
  fhir:restoreDate [ dateTime ] ; # 0..1 The date when the item is due to be placed back on the market by the owner, manufacturer or distributor, after a suspension

]

Changes since Release 3

Changes from both R4 and R4B

MarketingStatus
MarketingStatus.country
  • Min Cardinality changed from 1 to 0
MarketingStatus.dateRange
  • Min Cardinality changed from 1 to 0

See the Full Difference for further information

Structure

Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology
Name Flags Card. Type Description & Constraints      Filter: Filters doco
. . MarketingStatus Σ D N Element The marketing status describes the date when a medicinal product an item is actually put on the market or the date as of which it is no longer available

Elements defined in Ancestors: id , extension , modifierExtension
. . . country Σ 0..1 CodeableConcept The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements status applies
. . . jurisdiction Σ 0..1 CodeableConcept The controlled term and jurisdiction in which the controlled term identifier shall be specified marketing status applies
. . . status Σ 1..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 item
. . . restoreDate Σ 0..1 dateTime The date when the Medicinal Product item is due to be placed back on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in owner, manufacturer or distributor, after 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 suspension

doco Documentation for this format icon

UML Diagram ( Legend )

MarketingStatus The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements status applies country : CodeableConcept [0..1] Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and jurisdiction in which the controlled term identifier shall be specified marketing status applies jurisdiction : CodeableConcept [0..1] This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples item status : CodeableConcept [1..1] The date when dates that the Medicinal Product item is placed made available on the market by the Marketing Authorization Holder owner (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 jurisdiction. Note that “on the market” refers to the release of the Medicinal Product item into the distribution chain dateRange : Period [0..1] The date when the Medicinal Product item is due to be placed back on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in owner, manufacturer or distributor, after 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 suspension restoreDate : dateTime [0..1] BackboneType May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself) (this element modifies the meaning of other elements) modifierExtension : Extension [0..*]

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .

[
 # from Element: 
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:

 # from Element: fhir:extension
  fhir:country [ CodeableConcept ] ; # 0..1 The country in which the marketing status applies
  fhir:jurisdiction [ CodeableConcept ] ; # 0..1 The jurisdiction in which the marketing status applies
  fhir:status [ CodeableConcept ] ; # 1..1 This attribute provides information on the status of the marketing of the item
  fhir:dateRange [ Period ] ; # 0..1 The dates that the item is made available on the market by the owner (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction. Note that “on the market” refers to the release of the item into the distribution chain
  fhir:restoreDate [ dateTime ] ; # 0..1 The date when the item is due to be placed back on the market by the owner, manufacturer or distributor, after a suspension

]

Changes since Release 3

Changes from both R4 and R4B

MarketingStatus
MarketingStatus.country
  • Min Cardinality changed from 1 to 0
MarketingStatus.dateRange
  • Min Cardinality changed from 1 to 0

See the Full Difference for further information

Constraints

MarketingStatus is used in the following places: ManufacturedItemDefinition , MedicinalProductDefinition and PackagedProductDefinition