MedicinalProductAuthorization

draftResource40 elementsv4.0.1

The regulatory authorization of a medicinal product.

Metadata

Canonical URL: http://hl7.org/fhir/StructureDefinition/MedicinalProductAuthorization
ID: MedicinalProductAuthorization
Type
Base Definition
Derivation: specialization
Publisher: Health Level Seven International (Biomedical Research and Regulation)
Version: 4.0.1

Path	Card.	Type	Description
`MedicinalProductAuthorization`	`0..*`		The regulatory authorization of a medicinal product
`id`	`0..1`	string	Logical id of this artifact
`meta`	`0..1`	Meta	Metadata about the resource
`implicitRules`	`0..1`	uri	A set of rules under which this content was created
`language`	`0..1`	code	Language of the resource contentpreferred: languages
`text`	`0..1`	Narrative	Text summary of the resource, for human interpretation
`contained`	`0..*`	Resource	Contained, inline Resources
`extension`	`0..*`	Extension	Additional content defined by implementations
`modifierExtension`	`0..*`	Extension	Extensions that cannot be ignored
`identifier`	`0..*`	Identifier	Business identifier for the marketing authorization, as assigned by a regulator
`subject`	`0..1`	Reference	The medicinal product that is being authorized
`country`	`0..*`	CodeableConcept	The country in which the marketing authorization has been granted
`jurisdiction`	`0..*`	CodeableConcept	Jurisdiction within a country
`status`	`0..1`	CodeableConcept	The status of the marketing authorization
`statusDate`	`0..1`	dateTime	The date at which the given status has become applicable
`restoreDate`	`0..1`	dateTime	The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored
`validityPeriod`	`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`	`0..1`	Period	A period of time after authorization before generic product applicatiosn can be submitted
`dateOfFirstAuthorization`	`0..1`	dateTime	The date when the first authorization was granted by a Medicines Regulatory Agency
`internationalBirthDate`	`0..1`	dateTime	Date of first marketing authorization for a company's new medicinal product in any country in the World
`legalBasis`	`0..1`	CodeableConcept	The legal framework against which this authorization is granted
`jurisdictionalAuthorization`	`0..*`	BackboneElement	Authorization in areas within a country
`holder`	`0..1`	Reference	Marketing Authorization Holder
`regulator`	`0..1`	Reference	Medicines Regulatory Agency
`procedure`	`0..1`	BackboneElement	The regulatory procedure for granting or amending a marketing authorization