http://hl7.org/fhir/StructureDefinition/MedicinalProductAuthorization|4.0.1

The regulatory authorization of a medicinal product.

Structure JSON Dependencies FHIRSchema Other Versions Dependant (0)Elements Summary

Name	Flags	Card	Type	Description & Constraints
MedicinalProductAuthorization		0..*		The regulatory authorization of a medicinal product
identifier	Σ	0..*	Identifier	Business identifier for the marketing authorization, as assigned by a regulator
subject	Σ	0..1	Reference	The medicinal product that is being authorized
country	Σ	0..*	CodeableConcept	The country in which the marketing authorization has been granted
jurisdiction	Σ	0..*	CodeableConcept	Jurisdiction within a country
status	Σ	0..1	CodeableConcept	The status of the marketing authorization
statusDate	Σ	0..1	dateTime	The date at which the given status has become applicable
restoreDate	Σ	0..1	dateTime	The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored
validityPeriod	Σ	0..1	Period	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
dataExclusivityPeriod	Σ	0..1	Period	A period of time after authorization before generic product applicatiosn can be submitted
dateOfFirstAuthorization	Σ	0..1	dateTime	The date when the first authorization was granted by a Medicines Regulatory Agency
internationalBirthDate	Σ	0..1	dateTime	Date of first marketing authorization for a company's new medicinal product in any country in the World
legalBasis	Σ	0..1	CodeableConcept	The legal framework against which this authorization is granted
jurisdictionalAuthorization	Σ	0..*	BackboneElement	Authorization in areas within a country
identifier	Σ	0..*	Identifier	The assigned number for the marketing authorization
country	Σ	0..1	CodeableConcept	Country of authorization
jurisdiction	Σ	0..*	CodeableConcept	Jurisdiction within a country
legalStatusOfSupply	Σ	0..1	CodeableConcept	The legal status of supply in a jurisdiction or region
validityPeriod	Σ	0..1	Period	The start and expected end date of the authorization
holder	Σ	0..1	Reference	Marketing Authorization Holder
regulator	Σ	0..1	Reference	Medicines Regulatory Agency
procedure	Σ	0..1	BackboneElement	The regulatory procedure for granting or amending a marketing authorization
identifier	Σ	0..1	Identifier	Identifier for this procedure
type *	Σ	1..1	CodeableConcept	Type of procedure
date[x]	Σ	0..1		Date of procedure
datePeriod	Σ	0..1	Period
dateDateTime	Σ	0..1	dateTime
application	Σ	0..*		Applcations submitted to obtain a marketing authorization