MedicinalProductAuthorization | Medplum
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The regulatory authorization of a medicinal product.
Elements
| Name | Required | Type | Description |
|---|---|---|---|
| identifier | Identifier[] | Business identifier for the marketing authorization, as assigned by a regulator Details Business identifier for the marketing authorization, as assigned by a regulator. |
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| subject | Reference< MedicinalProduct | MedicinalProductPackaged > | |
| country | CodeableConcept[] | The country in which the marketing authorization has been granted Details The country in which the marketing authorization has been granted. |
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| jurisdiction | CodeableConcept[] | Jurisdiction within a country Details Jurisdiction within a country. |
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| status | CodeableConcept | The status of the marketing authorization Details The status of the marketing authorization. |
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| statusDate | dateTime | The date at which the given status has become applicable Details The date at which the given status has become applicable. |
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| restoreDate | dateTime | The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored Details The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored. |
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| validityPeriod | Period | The 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 Details The 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. |
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| dataExclusivityPeriod | Period | A period of time after authorization before generic product applications can be submitted Details A period of time after authorization before generic product applications can be submitted. |
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| dateOfFirstAuthorization | dateTime | The date when the first authorization was granted by a Medicines Regulatory Agency Details The date when the first authorization was granted by a Medicines Regulatory Agency. |
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| internationalBirthDate | dateTime | Date of first marketing authorization for a company's new medicinal product in any country in the World Details Date of first marketing authorization for a company's new medicinal product in any country in the World. |
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| legalBasis | CodeableConcept | The legal framework against which this authorization is granted Details The legal framework against which this authorization is granted. |
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| jurisdictionalAuthorization | MedicinalProductAuthorizationJurisdictionalAuthorization[] | Authorization in areas within a country Details Authorization in areas within a country. |
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| id | string | Unique id for inter-element referencing Details Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
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| extension | Extension[] | Additional content defined by implementations Details May be used to represent additional information that is not part of the basic definition of the element. |
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| modifierExtension | Extension[] | Extensions that cannot be ignored even if unrecognized Details May be used to represent additional information that modifies the understanding of the element in which it is contained. |
Search Parameters
| Name | Type | Description | Expression |
|---|---|---|---|
| country | token | The country in which the marketing authorization has been granted | MedicinalProductAuthorization.country |
| holder | reference | Marketing Authorization Holder | MedicinalProductAuthorization.holder |
| identifier | token | Business identifier for the marketing authorization, as assigned by a regulator | MedicinalProductAuthorization.identifier |
| status | token | The status of the marketing authorization | MedicinalProductAuthorization.status |
| subject | reference | The medicinal product that is being authorized | MedicinalProductAuthorization.subject |
Inherited Elements
| Name | Required | Type | Description |
|---|---|---|---|
| id | string | Logical id of this artifact Details The logical id of the resource, as used in the URL for the resource. |
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| meta | Meta | Metadata about the resource Details The metadata about the resource. |
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| implicitRules | uri | A set of rules under which this content was created Details A reference to a set of rules that were followed when the resource was constructed. |
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| language | code | Language of the resource content Details The base language in which the resource is written. |
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| text | Narrative | Text summary of the resource, for human interpretation Details A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. |
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| contained | Resource[] | Contained, inline Resources Details These resources do not have an independent existence apart from the resource that contains them. |
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| extension | Extension[] | Additional content defined by implementations Details May be used to represent additional information that is not part of the basic definition of the resource. |
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| modifierExtension | Extension[] | Extensions that cannot be ignored Details May be used to represent additional information that modifies the understanding of the element that contains it. |
Note
This resource is still undergoing development and review by the appropriate Workgroups. At this time, is considered only as a draft resource not suitable for production implementation
MedicinalProductAuthorization is a resource covering the Marketing Authorization of a Medicinal Product, from a regulatory point of view.