Name | Flags | Card. | Type | Description & Constraints![]() |
---|---|---|---|---|
ΣD | DomainResource | The regulatory authorization of a medicinal product Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension | ||
Σ | 0..1 | Identifier | Business identifier for the marketing authorization, as assigned by a regulator | |
Σ | 1..* | CodeableConcept | The country in which the marketing authorization has been granted | |
Σ | 1..1 | CodeableConcept | The legal status of supply of the medicinal product as classified by the regulator | |
Σ | 1..1 | CodeableConcept | The status of the marketing authorization | |
Σ | 1..1 | dateTime | The date at which the given status has become applicable | |
Σ | 0..1 | dateTime | The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored | |
Σ | 1..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 | |
Σ | 0..1 | Period | A period of time after authorization before generic product applicatiosn can be submitted | |
Σ | 0..1 | dateTime | The date when the first authorization was granted by a Medicines Regulatory Agency | |
Σ | 1..1 | dateTime | Date of first marketing authorization for a company's new medicinal product in any country in the World | |
Σ | 0..* | BackboneElement | Authorization in areas within a country | |
Σ | 1..1 | CodeableConcept | Country of authorization | |
Σ | 0..1 | CodeableConcept | Jurisdiction within a country | |
Σ | 0..1 | Identifier | The assigned number for the marketing authorization | |
Σ | 0..1 | CodeableConcept | The legal status of supply in a jurisdiction or region | |
Σ | 1..1 | Reference(Organization) | Marketing Authorization Holder | |
Σ | 1..1 | Reference(Organization) | Medicines Regulatory Agency | |
Σ | 1..1 | BackboneElement | The regulatory procedure for granting or amending a marketing authorization | |
Σ | 0..1 | Identifier | Identifier for this procedure | |
Σ | 1..1 | CodeableConcept | Type of procedure | |
Σ | 0..1 | Period | Date of procedure | |
Σ | 0..* | BackboneElement | Applcations submitted to obtain a marketing authorization | |
Σ | 1..1 | Identifier | 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 | |
Σ | 1..1 | CodeableConcept | The type of the application | |
Σ | 1..1 | dateTime | Date that the application was made | |
Σ | 0..* | MarketingStatus | Marketing status of the medicinal product, in contrast to marketing authorizaton | |
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