MedicinalProductAuthorization

R4 Draft for Comment

This page is part of the FHIR Specification (v3.2.0: R4 Ballot 1). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

11.7.4 Resource MedicinalProductAuthorization - Detailed Descriptions

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Draft

Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the MedicinalProductAuthorization resource.

MedicinalProductAuthorization
Definition	The regulatory authorization of a medicinal product.
Control	1..1
Summary	true
MedicinalProductAuthorization.identifier
Definition	Business identifier for the marketing authorization, as assigned by a regulator.
Note	This is a business identifer, not a resource identifier (see discussion)
Control	0..1
Type	Identifier
Summary	true
MedicinalProductAuthorization.country
Definition	The country in which the marketing authorization has been granted.
Control	1..*
Type	CodeableConcept
Summary	true
MedicinalProductAuthorization.legalStatusOfSupply
Definition	The legal status of supply of the medicinal product as classified by the regulator.
Control	1..1
Type	CodeableConcept
Summary	true
MedicinalProductAuthorization.status
Definition	The status of the marketing authorization.
Control	1..1
Type	CodeableConcept
Summary	true
MedicinalProductAuthorization.statusDate
Definition	The date at which the given status has become applicable.
Control	1..1
Type	dateTime
Summary	true
MedicinalProductAuthorization.restoreDate
Definition	The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored.
Control	0..1
Type	dateTime
Summary	true
MedicinalProductAuthorization.validityPeriod
Definition	The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.
Control	1..1
Type	Period
Summary	true
MedicinalProductAuthorization.dataExclusivityPeriod
Definition	A period of time after authorization before generic product applicatiosn can be submitted.
Control	0..1
Type	Period
Summary	true
MedicinalProductAuthorization.dateOfFirstAuthorization
Definition	The date when the first authorization was granted by a Medicines Regulatory Agency.
Control	0..1
Type	dateTime
Summary	true
MedicinalProductAuthorization.internationalBirthDate
Definition	Date of first marketing authorization for a company's new medicinal product in any country in the World.
Control	1..1
Type	dateTime
Summary	true
MedicinalProductAuthorization.jurisdictionalAuthorization
Definition	Authorization in areas within a country.
Control	0..*
Summary	true
MedicinalProductAuthorization.jurisdictionalAuthorization.country
Definition	Country of authorization.
Control	1..1
Type	CodeableConcept
Summary	true
MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction
Definition	Jurisdiction within a country.
Control	0..1
Type	CodeableConcept
Summary	true
MedicinalProductAuthorization.jurisdictionalAuthorization.number
Definition	The assigned number for the marketing authorization.
Control	0..1
Type	Identifier
Summary	true
MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply
Definition	The legal status of supply in a jurisdiction or region.
Control	0..1
Type	CodeableConcept
Summary	true
MedicinalProductAuthorization.holder
Definition	Marketing Authorization Holder.
Control	1..1
Type	Reference(Organization)
Summary	true
MedicinalProductAuthorization.regulator
Definition	Medicines Regulatory Agency.
Control	1..1
Type	Reference(Organization)
Summary	true
MedicinalProductAuthorization.procedure
Definition	The regulatory procedure for granting or amending a marketing authorization.
Control	1..1
Summary	true
MedicinalProductAuthorization.procedure.number
Definition	Identifier for this procedure.
Control	0..1
Type	Identifier
Summary	true
MedicinalProductAuthorization.procedure.type
Definition	Type of procedure.
Control	1..1
Type	CodeableConcept
Summary	true
MedicinalProductAuthorization.procedure.date
Definition	Date of procedure.
Control	0..1
Type	Period
Summary	true
MedicinalProductAuthorization.procedure.application
Definition	Applcations submitted to obtain a marketing authorization.
Control	0..*
Summary	true
MedicinalProductAuthorization.procedure.application.number
Definition	A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency.
Control	1..1
Type	Identifier
Summary	true
MedicinalProductAuthorization.procedure.application.type
Definition	The type of the application.
Control	1..1
Type	CodeableConcept
Summary	true
MedicinalProductAuthorization.procedure.application.date
Definition	Date that that application was made.
Control	1..1
Type	dateTime
Summary	true
MedicinalProductAuthorization.marketingStatus
Definition	Marketing status of the medicinal product, in contrast to marketing authorizaton.
Control	0..*
Type	MarketingStatus
Summary	true