Optional_Optional_A set of rules under which this content was created
Optional_Language of the resource content
Optional_The date at which the current status was assigned
OptionalbasisThe legal/regulatory framework or reasons under which this authorization is granted
OptionalcaseThe case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)
OptionalcontainedContained, inline Resources
OptionaldescriptionGeneral textual supporting information
OptionalextensionAdditional content defined by implementations
OptionalholderThe organization that has been granted this authorization, by the regulator
OptionalidLogical id of this artifact
OptionalidentifierBusiness identifier for the authorization, typically assigned by the authorizing body
OptionalimplicitA set of rules under which this content was created
OptionalindicationCondition for which the use of the regulated product applies
OptionalintendedThe intended use of the product, e.g. prevention, treatment
OptionallanguageLanguage of the resource content
OptionalmetaMetadata about the resource
OptionalmodifierExtensions that cannot be ignored
OptionalregionThe territory in which the authorization has been granted
OptionalregulatorThe regulatory authority or authorizing body granting the authorization
OptionalstatusThe status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
OptionalstatusThe date at which the current status was assigned
OptionalsubjectThe product type, treatment, facility or activity that is being authorized
OptionaltextText summary of the resource, for human interpretation
OptionaltypeOverall type of this authorization, for example drug marketing approval, orphan drug designation
OptionalvalidityThe time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date
General textual supporting information