Release 5 Ballot

This page is part of the FHIR Specification (v5.0.0-ballot: R5 Ballot - see ballot notes). 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

15.15.0 MarketingStatus

Pharmacy icon Work GroupMaturity Level: 3Standards 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

NameFlagsCard.TypeDescription & Constraintsdoco
.. MarketingStatusΣDElementThe 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
... countryΣ0..1CodeableConceptThe 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
... jurisdictionΣ0..1CodeableConceptWhere 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
... statusΣ1..1CodeableConceptThis attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
... restoreDateΣ0..1dateTimeThe 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

Definition: XML | JSON

UML Diagram (Legend)

MarketingStatusThe country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elementscountry : 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 specifiedjurisdiction : 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 examplesstatus : 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 chaindateRange : 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 chainrestoreDate : dateTime [0..1]BackboneTypeMay 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 Element: extension -->
 <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><!-- 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 Element: extension
  "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 Element: Element.extension
  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: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
  • Min Cardinality changed from 1 to 0
MarketingStatus.dateRange
  • Min Cardinality changed from 1 to 0
  • Min Cardinality changed from 1 to 0

See the Full Difference for further information

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. MarketingStatusΣDElementThe 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
... countryΣ0..1CodeableConceptThe 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
... jurisdictionΣ0..1CodeableConceptWhere 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
... statusΣ1..1CodeableConceptThis attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
... restoreDateΣ0..1dateTimeThe 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)

MarketingStatusThe country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elementscountry : 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 specifiedjurisdiction : 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 examplesstatus : 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 chaindateRange : 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 chainrestoreDate : dateTime [0..1]BackboneTypeMay 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 Element: extension -->
 <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><!-- 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 Element: extension
  "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 Element: Element.extension
  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: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
  • Min Cardinality changed from 1 to 0
MarketingStatus.dateRange
  • Min Cardinality changed from 1 to 0
  • 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