Resource type: medicinalproductauthorization

Description

The regulatory authorization of a medicinal product.

Elements

PathShortDefinitionComments
The regulatory authorization of a medicinal productThe regulatory authorization of a medicinal product.
identifierBusiness identifier for the marketing authorization, as assigned by a regulatorBusiness identifier for the marketing authorization, as assigned by a regulator.
subjectThe medicinal product that is being authorizedThe medicinal product that is being authorized.
countryThe country in which the marketing authorization has been grantedThe country in which the marketing authorization has been granted.
jurisdictionJurisdiction within a countryJurisdiction within a country.
statusThe status of the marketing authorizationThe status of the marketing authorization.
statusDateThe date at which the given status has become applicableThe date at which the given status has become applicable.
restoreDateThe date when a suspended the marketing or the marketing authorization of the product is anticipated to be restoredThe date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored.
validityPeriodThe 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 formatThe 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.
dataExclusivityPeriodA period of time after authorization before generic product applicatiosn can be submittedA period of time after authorization before generic product applicatiosn can be submitted.
dateOfFirstAuthorizationThe date when the first authorization was granted by a Medicines Regulatory AgencyThe date when the first authorization was granted by a Medicines Regulatory Agency.
internationalBirthDateDate of first marketing authorization for a company's new medicinal product in any country in the WorldDate of first marketing authorization for a company's new medicinal product in any country in the World.
legalBasisThe legal framework against which this authorization is grantedThe legal framework against which this authorization is granted.
jurisdictionalAuthorizationAuthorization in areas within a countryAuthorization in areas within a country.
jurisdictionalAuthorization.idUnique id for inter-element referencingUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
jurisdictionalAuthorization.extensionAdditional content defined by implementationsMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
jurisdictionalAuthorization.modifierExtensionExtensions that cannot be ignored even if unrecognizedMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
jurisdictionalAuthorization.identifierThe assigned number for the marketing authorizationThe assigned number for the marketing authorization.
jurisdictionalAuthorization.countryCountry of authorizationCountry of authorization.
jurisdictionalAuthorization.jurisdictionJurisdiction within a countryJurisdiction within a country.
jurisdictionalAuthorization.legalStatusOfSupplyThe legal status of supply in a jurisdiction or regionThe legal status of supply in a jurisdiction or region.
jurisdictionalAuthorization.validityPeriodThe start and expected end date of the authorizationThe start and expected end date of the authorization.
holderMarketing Authorization HolderMarketing Authorization Holder.
regulatorMedicines Regulatory AgencyMedicines Regulatory Agency.
procedureThe regulatory procedure for granting or amending a marketing authorizationThe regulatory procedure for granting or amending a marketing authorization.
procedure.idUnique id for inter-element referencingUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
procedure.extensionAdditional content defined by implementationsMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
procedure.modifierExtensionExtensions that cannot be ignored even if unrecognizedMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
procedure.identifierIdentifier for this procedureIdentifier for this procedure.
procedure.typeType of procedureType of procedure.
procedure.date[x]Date of procedureDate of procedure.
procedure.applicationApplcations submitted to obtain a marketing authorizationApplcations submitted to obtain a marketing authorization.


Scope and Usage

MedicinalProductAuthorization is a resource covering the Marketing Authorization of a Medicinal Product, from a regulatory point of view.



Search Parameters

countryThe country in which the marketing authorization has been grantedMedicinalProductAuthorization.country
holderMarketing Authorization HolderMedicinalProductAuthorization.holder
identifierBusiness identifier for the marketing authorization, as assigned by a regulatorMedicinalProductAuthorization.identifier
statusThe status of the marketing authorizationMedicinalProductAuthorization.status
subjectThe medicinal product that is being authorizedMedicinalProductAuthorization.subject

Extension Definitions

These are extension definitions for this resource defined by the spec