Release 4B Ballot #1

15.10.0 MarketingStatus

Pharmacy

Work Group

Maturity Level: 3

Standards Status: Trial Use

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

Name	Flags	Card.	Type	Description & Constraints
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
dateRange	Σ	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
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
Documentation for this format

UML Diagram (Legend)

XML Template

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

{
  // 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: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

MarketingStatus.dateRange

Min Cardinality changed from 1 to 0

See the Full Difference for further information