Release 4 4B
This page is part of the FHIR Specification (v4.0.1: R4 - Mixed Normative and STU ) in it's permanent home (it will always be available at this URL). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4

11.27.0 15.10.0 MarketingStatus

Pharmacy Work Group Maturity Level : 3 Standards Status : Trial Use
This type

The MarketingStatus structure allows specifying that an item or product is still undergoing development on the market for sale, or that it is not available, and review by the appropriate Workgroups. At this time, dates associated. This refers to a marketing choice rather than having permission, and so is considered only as a draft design not suitable for production implementation The MarketingStatus structure defines TODO. different concept to it being approved, cleared or licenced to be on sale (for which see RegulatedAuthorization ).

Note: the MarketingStatus structure allows modifier extensions .

11.27.0.1 15.10.0.1 Content

Structure

1..1
Name Flags Card. Type Description & Constraints doco
. . MarketingStatus Σ D BackBoneElement The marketing status describes the date when a medicinal product 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 authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
. . . jurisdiction Σ 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
. . . 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
. . . restoreDate Σ 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

doco Documentation for this format

UML Diagram ( Legend )

BackboneElement Extensions - as described for all elements: additional information that is not part of the basic definition of the resource / type extension : Extension 0..* Modifier Extensions - as described for some elements: additional information that is not part of the basic definition of the resource / type that modifies the interpretation of the containing element modifierExtension : Extension 0..* MarketingStatus 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 country : CodeableConcept [1..1] [0..1] 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 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 status : CodeableConcept [1..1] 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 dateRange : Period [1..1] [0..1] 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 restoreDate : dateTime [0..1] BackboneElement 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 manageable, 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..*]

XML Template 

<MarketingStatus xmlns="http://hl7.org/fhir">
 <!-- from BackboneElement: extension, modifierExtension -->
 <</country>

 <country><!-- 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 --></country>

 <jurisdiction><!-- 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 --></jurisdiction>
 <status><!-- 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 --></status>
 <</dateRange>

 <dateRange><!-- 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 --></dateRange>

 <restoreDate value="[dateTime]"/><!-- 0..1 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 -->
</MarketingStatus>

JSON Template 

{doco
  // from BackboneElement: extension, modifierExtension
  "

  "country" : { 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

  "jurisdiction" : { 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
  "status" : { CodeableConcept }, // R!  This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
  "
  "

  "dateRange" : { 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
  "restoreDate" : "<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

}

Turtle Template 

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

[
 # from BackboneElement: Element.extension, BackboneElement.modifierextension
  fhir:

  fhir:MarketingStatus.country [ CodeableConcept ]; # 0..1 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

  fhir:MarketingStatus.jurisdiction [ CodeableConcept ]; # 0..1 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
  fhir:MarketingStatus.status [ CodeableConcept ]; # 1..1 This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
  fhir:
  fhir:

  fhir:MarketingStatus.dateRange [ Period ]; # 0..1 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
  fhir:MarketingStatus.restoreDate [ dateTime ]; # 0..1 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

]

Changes since Release 3

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

This complex-type did not exist in Release 2 See the Full Difference for further information

Structure

1..1
Name Flags Card. Type Description & Constraints doco
. . MarketingStatus Σ D BackBoneElement The marketing status describes the date when a medicinal product 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 authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
. . . jurisdiction Σ 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
. . . 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
. . . restoreDate Σ 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

doco Documentation for this format

UML Diagram ( Legend )

BackboneElement Extensions - as described for all elements: additional information that is not part of the basic definition of the resource / type extension : Extension 0..* Modifier Extensions - as described for some elements: additional information that is not part of the basic definition of the resource / type that modifies the interpretation of the containing element modifierExtension : Extension 0..* MarketingStatus 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 country : CodeableConcept [1..1] [0..1] 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 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 status : CodeableConcept [1..1] 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 dateRange : Period [1..1] [0..1] 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 restoreDate : dateTime [0..1] BackboneElement 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 manageable, 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..*]

XML Template 

<MarketingStatus xmlns="http://hl7.org/fhir">
 <!-- from BackboneElement: extension, modifierExtension -->
 <</country>

 <country><!-- 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 --></country>

 <jurisdiction><!-- 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 --></jurisdiction>
 <status><!-- 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 --></status>
 <</dateRange>

 <dateRange><!-- 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 --></dateRange>

 <restoreDate value="[dateTime]"/><!-- 0..1 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 -->
</MarketingStatus>

JSON Template 

{doco
  // from BackboneElement: extension, modifierExtension
  "

  "country" : { 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

  "jurisdiction" : { 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
  "status" : { CodeableConcept }, // R!  This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
  "
  "

  "dateRange" : { 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
  "restoreDate" : "<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

}

Turtle Template 

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

[
 # from BackboneElement: Element.extension, BackboneElement.modifierextension
  fhir:

  fhir:MarketingStatus.country [ CodeableConcept ]; # 0..1 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

  fhir:MarketingStatus.jurisdiction [ CodeableConcept ]; # 0..1 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
  fhir:MarketingStatus.status [ CodeableConcept ]; # 1..1 This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
  fhir:
  fhir:

  fhir:MarketingStatus.dateRange [ Period ]; # 0..1 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
  fhir:MarketingStatus.restoreDate [ dateTime ]; # 0..1 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

]

Changes since Release 3

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

This complex-type did not exist in Release 2 See the Full Difference for further information

Constraints

MarketingStatus is used in the following places: MedicinalProduct MedicinalProductDefinition and MedicinalProductPackaged PackagedProductDefinition

11.27.0.2 15.10.0.2 Interpretation of MarketingStatus in different contexts