MedicinalProductAuthorization
MedicinalProductAuthorization
The regulatory authorization of a medicinal product.
Properties
| Name | Required | Type | Description |
|---|---|---|---|
| identifier | No | Identifier[] | Business identifier for the marketing authorization, as assigned by a regulator |
| subject | No | Reference<MedicinalProduct / MedicinalProductPackaged> | The medicinal product that is being authorized |
| country | No | CodeableConcept[] | The country in which the marketing authorization has been granted |
| jurisdiction | No | CodeableConcept[] | Jurisdiction within a country |
| status | No | CodeableConcept | The status of the marketing authorization |
| statusDate | No | dateTime | The date at which the given status has become applicable |
| restoreDate | No | dateTime | The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored |
| validityPeriod | No | 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 |
| dataExclusivityPeriod | No | Period | A period of time after authorization before generic product applicatiosn can be submitted |
| dateOfFirstAuthorization | No | dateTime | The date when the first authorization was granted by a Medicines Regulatory Agency |
| internationalBirthDate | No | dateTime | Date of first marketing authorization for a company’s new medicinal product in any country in the World |
| legalBasis | No | CodeableConcept | The legal framework against which this authorization is granted |
| jurisdictionalAuthorization | No | MedicinalProductAuthorizationJurisdictionalAuthorization | Authorization in areas within a country |
| - id | No | string | Unique id for inter-element referencing |
| - extension | No | Extension[] | Additional content defined by implementations |
| - modifierExtension | No | Extension[] | Extensions that cannot be ignored even if unrecognized |
| - identifier | No | Identifier[] | The assigned number for the marketing authorization |
| - country | No | CodeableConcept | Country of authorization |
| - jurisdiction | No | CodeableConcept[] | Jurisdiction within a country |
| - legalStatusOfSupply | No | CodeableConcept | The legal status of supply in a jurisdiction or region |
| - validityPeriod | No | Period | The start and expected end date of the authorization |
| holder | No | Reference<Organization> | Marketing Authorization Holder |
| regulator | No | Reference<Organization> | Medicines Regulatory Agency |
| procedure | No | MedicinalProductAuthorizationProcedure | The regulatory procedure for granting or amending a marketing authorization |
| - id | No | string | Unique id for inter-element referencing |
| - extension | No | Extension[] | Additional content defined by implementations |
| - modifierExtension | No | Extension[] | Extensions that cannot be ignored even if unrecognized |
| - identifier | No | Identifier | Identifier for this procedure |
| - type | Yes | CodeableConcept | Type of procedure |
| - date[x] | No | Period, dateTime | Date of procedure |
| - application | No | [] | Applcations submitted to obtain a marketing authorization |
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 Properties
| Name | Required | Type | Description |
|---|---|---|---|
| id | No | string | Logical id of this artifact |
| meta | No | Meta | Metadata about the resource |
| implicitRules | No | uri | A set of rules under which this content was created |
| language | No | code | Language of the resource content |
| text | No | Narrative | Text summary of the resource, for human interpretation |
| contained | No | Resource[] | Contained, inline Resources |
| extension | No | Extension[] | Additional content defined by implementations |
| modifierExtension | No | Extension[] | Extensions that cannot be ignored |
To view the FHIR specification for this resource, see MedicinalProductAuthorization.