MedicinalProductAuthorization
The regulatory authorization of a medicinal product.
- Backends
- PostgreSQLElasticsearch
- Interactions
- CreateReadUpdatePatchDelete
- Search
- 5 of 5 parameters tested
Structure
| Element | Card. | Type | Description |
|---|---|---|---|
identifierΣ | 0..* | Identifier | Business identifier for the marketing authorization, as assigned by a regulator |
subjectΣ | 0..1 | Reference(MedicinalProduct | MedicinalProductPackaged) | The medicinal product that is being authorized |
countryΣ | 0..* | CodeableConcept | The country in which the marketing authorization has been granted |
jurisdictionΣ | 0..* | CodeableConcept | Jurisdiction within a country |
statusΣ | 0..1 | CodeableConcept | The status of the marketing authorization |
statusDateΣ | 0..1 | dateTime | The date at which the given status has become applicable |
restoreDateΣ | 0..1 | dateTime | The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored |
validityPeriodΣ | 0..1 | 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 |
dataExclusivityPeriodΣ | 0..1 | Period | A period of time after authorization before generic product applicatiosn can be submitted |
dateOfFirstAuthorizationΣ | 0..1 | dateTime | The date when the first authorization was granted by a Medicines Regulatory Agency |
internationalBirthDateΣ | 0..1 | dateTime | Date of first marketing authorization for a company's new medicinal product in any country in the World |
legalBasisΣ | 0..1 | CodeableConcept | The legal framework against which this authorization is granted |
jurisdictionalAuthorizationΣ | 0..* | BackboneElement | Authorization in areas within a country |
identifierΣ | 0..* | Identifier | The assigned number for the marketing authorization |
countryΣ | 0..1 | CodeableConcept | Country of authorization |
jurisdictionΣ | 0..* | CodeableConcept | Jurisdiction within a country |
legalStatusOfSupplyΣ | 0..1 | CodeableConcept | The legal status of supply in a jurisdiction or region |
validityPeriodΣ | 0..1 | Period | The start and expected end date of the authorization |
holderΣ | 0..1 | Reference(Organization) | Marketing Authorization Holder |
regulatorΣ | 0..1 | Reference(Organization) | Medicines Regulatory Agency |
procedureΣ | 0..1 | BackboneElement | The regulatory procedure for granting or amending a marketing authorization |
identifierΣ | 0..1 | Identifier | Identifier for this procedure |
typeRequiredΣ | 1..1 | CodeableConcept | Type of procedure |
date[x]Σ | 0..1 | Period | dateTime | Date of procedure |
applicationΣ | 0..* | Same as MedicinalProductAuthorization.procedure | Applcations submitted to obtain a marketing authorization |
Σ in _summary results · ?! modifier element · 1.. required · inherited elements in grey
Search parameters
Query with GET [base]/MedicinalProductAuthorization?[parameter]=[value]. Type decides which modifiers and prefixes apply, see search features.
| Parameter | Type | Description | PG | ES |
|---|---|---|---|---|
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 |
PG: PostgreSQL, ES: Elasticsearch. passes its TestScript checks, fails, not tested yet. The author of the resource Logical id of this artifact When the resource version last changed Profiles this resource claims to conform to Security Labels applied to this resource Identifies where the resource comes from Tags applied to this resource Derived from the R4B DefinitionCommon parameters on every resource (8)
_haste-health-authorreference _idtoken _lastUpdateddate _profileuri _securitytoken _sourceuri _tagtoken _typetoken