MedicinalProductAuthorization

R4 Ballot #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.5.0: R4 Ballot #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

11.8.5 Resource MedicinalProductAuthorization - Detailed Descriptions

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Trial Use

Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the MedicinalProductAuthorization resource.

MedicinalProductAuthorization
Element Id	MedicinalProductAuthorization
Definition	The regulatory authorization of a medicinal product.
Control	1..1
Type	DomainResource
Summary	true
MedicinalProductAuthorization.identifier
Element Id	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..*
Type	Identifier
Summary	true
MedicinalProductAuthorization.subject
Element Id	MedicinalProductAuthorization.subject
Definition	The medicinal product that is being authorized.
Control	0..1
Type	Reference(MedicinalProduct \| MedicinalProductPackaged)
Summary	true
MedicinalProductAuthorization.country
Element Id	MedicinalProductAuthorization.country
Definition	The country in which the marketing authorization has been granted.
Control	0..*
Type	CodeableConcept
Summary	true
MedicinalProductAuthorization.jurisdiction
Element Id	MedicinalProductAuthorization.jurisdiction
Definition	Jurisdiction within a country.
Control	0..*
Type	CodeableConcept
Summary	true
MedicinalProductAuthorization.legalStatusOfSupply
Element Id	MedicinalProductAuthorization.legalStatusOfSupply
Definition	The legal status of supply of the medicinal product as classified by the regulator.
Control	0..1
Type	CodeableConcept
Summary	true
MedicinalProductAuthorization.status
Element Id	MedicinalProductAuthorization.status
Definition	The status of the marketing authorization.
Control	0..1
Type	CodeableConcept
Summary	true
MedicinalProductAuthorization.statusDate
Element Id	MedicinalProductAuthorization.statusDate
Definition	The date at which the given status has become applicable.
Control	0..1
Type	dateTime
Summary	true
MedicinalProductAuthorization.restoreDate
Element Id	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
Element Id	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	0..1
Type	Period
Summary	true
MedicinalProductAuthorization.dataExclusivityPeriod
Element Id	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
Element Id	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
Element Id	MedicinalProductAuthorization.internationalBirthDate
Definition	Date of first marketing authorization for a company's new medicinal product in any country in the World.
Control	0..1
Type	dateTime
Summary	true
MedicinalProductAuthorization.legalBasis
Element Id	MedicinalProductAuthorization.legalBasis
Definition	The legal framework against which this authorization is granted.
Control	0..1
Type	CodeableConcept
Summary	true
MedicinalProductAuthorization.jurisdictionalAuthorization
Element Id	MedicinalProductAuthorization.jurisdictionalAuthorization
Definition	Authorization in areas within a country.
Control	0..*
Summary	true
MedicinalProductAuthorization.jurisdictionalAuthorization.identifier
Element Id	MedicinalProductAuthorization.jurisdictionalAuthorization.identifier
Definition	The assigned number for the marketing authorization.
Note	This is a business identifer, not a resource identifier (see discussion)
Control	0..*
Type	Identifier
Summary	true
MedicinalProductAuthorization.jurisdictionalAuthorization.country
Element Id	MedicinalProductAuthorization.jurisdictionalAuthorization.country
Definition	Country of authorization.
Control	0..1
Type	CodeableConcept
Summary	true
MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction
Element Id	MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction
Definition	Jurisdiction within a country.
Control	0..*
Type	CodeableConcept
Summary	true
MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply
Element Id	MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply
Definition	The legal status of supply in a jurisdiction or region.
Control	0..1
Type	CodeableConcept
Summary	true
MedicinalProductAuthorization.jurisdictionalAuthorization.validityPeriod
Element Id	MedicinalProductAuthorization.jurisdictionalAuthorization.validityPeriod
Definition	The start and expected end date of the authorization.
Control	0..1
Type	Period
Summary	true
MedicinalProductAuthorization.holder
Element Id	MedicinalProductAuthorization.holder
Definition	Marketing Authorization Holder.
Control	0..1
Type	Reference(Organization)
Summary	true
MedicinalProductAuthorization.regulator
Element Id	MedicinalProductAuthorization.regulator
Definition	Medicines Regulatory Agency.
Control	0..1
Type	Reference(Organization)
Summary	true
MedicinalProductAuthorization.procedure
Element Id	MedicinalProductAuthorization.procedure
Definition	The regulatory procedure for granting or amending a marketing authorization.
Control	0..1
Summary	true
MedicinalProductAuthorization.procedure.identifier
Element Id	MedicinalProductAuthorization.procedure.identifier
Definition	Identifier for this procedure.
Note	This is a business identifer, not a resource identifier (see discussion)
Control	0..1
Type	Identifier
Summary	true
MedicinalProductAuthorization.procedure.type
Element Id	MedicinalProductAuthorization.procedure.type
Definition	Type of procedure.
Control	1..1
Type	CodeableConcept
Summary	true
MedicinalProductAuthorization.procedure.date[x]
Element Id	MedicinalProductAuthorization.procedure.date[x]
Definition	Date of procedure.
Control	0..1
Type	Period\|dateTime
[x] Note	See Choice of Data Types for further information about how to use [x]
Summary	true
MedicinalProductAuthorization.procedure.application
Element Id	MedicinalProductAuthorization.procedure.application
Definition	Applcations submitted to obtain a marketing authorization.
Control	0..*
Type	See MedicinalProductAuthorization.procedure
Summary	true