MedicinalProductAuthorization
The regulatory authorization of a medicinal product.
These interaction paths describe standard FHIR R4 patterns. Availability can depend on the API capabilities enabled for your Ovok project.
| Interaction | Method | Path |
|---|---|---|
| Read | GET | /fhir/R4/MedicinalProductAuthorization/[id] |
| Vread | GET | /fhir/R4/MedicinalProductAuthorization/[id]/_history/[vid] |
| Update | PUT | /fhir/R4/MedicinalProductAuthorization/[id] |
| Patch | PATCH | /fhir/R4/MedicinalProductAuthorization/[id] |
| Delete | DELETE | /fhir/R4/MedicinalProductAuthorization/[id] |
| Create | POST | /fhir/R4/MedicinalProductAuthorization |
| Search | GET | /fhir/R4/MedicinalProductAuthorization |
| History | GET | /fhir/R4/MedicinalProductAuthorization/[id]/_history |
Top-level elements
| Element | Type | Cardinality | Description |
|---|---|---|---|
id | string | 0..1 | Logical id of this artifact |
meta | Meta | 0..1 | Metadata about the resource |
implicitRules | uri | 0..1 | A set of rules under which this content was created |
language | code | 0..1 | Language of the resource content |
text | Narrative | 0..1 | Text summary of the resource, for human interpretation |
contained | Resource | 0..* | Contained, inline Resources |
extension | Extension | 0..* | Additional content defined by implementations |
modifierExtension | Extension | 0..* | Extensions that cannot be ignored |
identifier | Identifier | 0..* | Business identifier for the marketing authorization, as assigned by a regulator |
subject | Reference | 0..1 | The medicinal product that is being authorized |
country | CodeableConcept | 0..* | The country in which the marketing authorization has been granted |
jurisdiction | CodeableConcept | 0..* | Jurisdiction within a country |
status | CodeableConcept | 0..1 | The status of the marketing authorization |
statusDate | dateTime | 0..1 | The date at which the given status has become applicable |
restoreDate | dateTime | 0..1 | The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored |
validityPeriod | Period | 0..1 | 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 | Period | 0..1 | A period of time after authorization before generic product applicatiosn can be submitted |
dateOfFirstAuthorization | dateTime | 0..1 | The date when the first authorization was granted by a Medicines Regulatory Agency |
internationalBirthDate | dateTime | 0..1 | Date of first marketing authorization for a company's new medicinal product in any country in the World |
legalBasis | CodeableConcept | 0..1 | The legal framework against which this authorization is granted |
jurisdictionalAuthorization | BackboneElement | 0..* | Authorization in areas within a country |
holder | Reference | 0..1 | Marketing Authorization Holder |
regulator | Reference | 0..1 | Medicines Regulatory Agency |
procedure | BackboneElement | 0..1 | The regulatory procedure for granting or amending a marketing authorization |
Resource-specific search parameters
| Parameter | Type | Description |
|---|---|---|
country | token | The country in which the marketing authorization has been granted |
holder | reference | Marketing Authorization Holder |
identifier | token | Business identifier for the marketing authorization, as assigned by a regulator |
status | token | The status of the marketing authorization |
subject | reference | The medicinal product that is being authorized |
Reference
Official FHIR R4 spec: MedicinalProductAuthorization.
Maturity: Draft (FMM 0).