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_descriptionOptional
_implicitA set of rules under which this content was created
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_languageLanguage of the resource content
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_statusThe date at which the current status was assigned
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basisThe legal/regulatory framework or reasons under which this authorization is granted
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caseThe 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)
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containedContained, inline Resources
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descriptionGeneral textual supporting information
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extensionAdditional content defined by implementations
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holderThe organization that has been granted this authorization, by the regulator
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idLogical id of this artifact
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identifierBusiness identifier for the authorization, typically assigned by the authorizing body
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implicitA set of rules under which this content was created
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indicationCondition for which the use of the regulated product applies
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intendedThe intended use of the product, e.g. prevention, treatment
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languageLanguage of the resource content
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metaMetadata about the resource
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modifierExtensions that cannot be ignored
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regionThe territory in which the authorization has been granted
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regulatorThe regulatory authority or authorizing body granting the authorization
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statusThe status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
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statusThe date at which the current status was assigned
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subjectThe product type, treatment, facility or activity that is being authorized
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textText summary of the resource, for human interpretation
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typeOverall type of this authorization, for example drug marketing approval, orphan drug designation
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validityThe 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