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MedicinalProductAuthorization

The regulatory authorization of a medicinal product.

Properties

NameCardTypeDescription
id0..1stringLogical id of this artifact
meta0..1MetaMetadata about the resource
implicitRules0..1uriA set of rules under which this content was created
language0..1codeLanguage of the resource content
text0..1NarrativeText summary of the resource, for human interpretation
contained0..*ResourceContained, inline Resources
extension0..*ExtensionAdditional content defined by implementations
modifierExtension0..*ExtensionExtensions that cannot be ignored
identifier0..*IdentifierBusiness identifier for the marketing authorization, as assigned by a regulator
subject0..1ReferenceThe medicinal product that is being authorized
country0..*CodeableConceptThe country in which the marketing authorization has been granted
jurisdiction0..*CodeableConceptJurisdiction within a country
status0..1CodeableConceptThe status of the marketing authorization
statusDate0..1dateTimeThe date at which the given status has become applicable
restoreDate0..1dateTimeThe date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored
validityPeriod0..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 | 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

Search Parameters

NameTypeDescriptionExpression
countrytokenThe country in which the marketing authorization has been grantedMedicinalProductAuthorization.country
holderreferenceMarketing Authorization HolderMedicinalProductAuthorization.holder
identifiertokenBusiness identifier for the marketing authorization, as assigned by a regulatorMedicinalProductAuthorization.identifier
statustokenThe status of the marketing authorizationMedicinalProductAuthorization.status
subjectreferenceThe medicinal product that is being authorizedMedicinalProductAuthorization.subject