NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductAuthorization ΣTUDomainResourceThe regulatory authorization of a medicinal product
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness identifier for the marketing authorization, as assigned by a regulator
... subject Σ0..1Reference(MedicinalProduct | MedicinalProductPackaged)The medicinal product that is being authorized
... country Σ0..*CodeableConceptThe country in which the marketing authorization has been granted
... jurisdiction Σ0..*CodeableConceptJurisdiction within a country
... legalStatusOfSupply Σ0..1CodeableConceptThe legal status of supply of the medicinal product as classified by the regulator
... status Σ0..1CodeableConceptThe status of the marketing authorization
... statusDate Σ0..1dateTimeThe date at which the given status has become applicable
... restoreDate Σ0..1dateTimeThe date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored
... validityPeriod Σ0..1PeriodThe 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 Σ0..1PeriodA period of time after authorization before generic product applicatiosn can be submitted
... dateOfFirstAuthorization Σ0..1dateTimeThe date when the first authorization was granted by a Medicines Regulatory Agency
... internationalBirthDate Σ0..1dateTimeDate of first marketing authorization for a company's new medicinal product in any country in the World
... legalBasis Σ0..1CodeableConceptThe legal framework against which this authorization is granted
... jurisdictionalAuthorization Σ0..*BackboneElementAuthorization in areas within a country
.... identifier Σ0..*IdentifierThe assigned number for the marketing authorization
.... country Σ0..1CodeableConceptCountry of authorization
.... jurisdiction Σ0..*CodeableConceptJurisdiction within a country
.... legalStatusOfSupply Σ0..1CodeableConceptThe legal status of supply in a jurisdiction or region
.... validityPeriod Σ0..1PeriodThe start and expected end date of the authorization
... holder Σ0..1Reference(Organization)Marketing Authorization Holder
... regulator Σ0..1Reference(Organization)Medicines Regulatory Agency
... procedure Σ0..1BackboneElementThe regulatory procedure for granting or amending a marketing authorization
.... identifier Σ0..1IdentifierIdentifier for this procedure
.... type Σ1..1CodeableConceptType of procedure
.... date[x] Σ0..1Date of procedure
..... datePeriodPeriod
..... dateDateTimedateTime
.... application Σ0..*see procedureApplcations submitted to obtain a marketing authorization

doco Documentation for this format