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MedicinalProductAuthorization

ResourceSpecialized · Medication DefinitionTrial useMaturity 0

The regulatory authorization of a medicinal product.

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5 of 5 parameters tested

Structure​

ElementCard.TypeDescription
identifierΣ
0..*IdentifierBusiness identifier for the marketing authorization, as assigned by a regulator
subjectΣ
0..1Reference(MedicinalProduct | MedicinalProductPackaged)The medicinal product that is being authorized
countryΣ
0..*CodeableConceptThe country in which the marketing authorization has been granted
jurisdictionΣ
0..*CodeableConceptJurisdiction within a country
statusΣ
0..1CodeableConceptThe status of the marketing authorization
statusDateΣ
0..1dateTimeThe date at which the given status has become applicable
restoreDateΣ
0..1dateTimeThe date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored
validityPeriodΣ
0..1PeriodThe 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..1PeriodA period of time after authorization before generic product applicatiosn can be submitted
dateOfFirstAuthorizationΣ
0..1dateTimeThe date when the first authorization was granted by a Medicines Regulatory Agency
internationalBirthDateΣ
0..1dateTimeDate of first marketing authorization for a company's new medicinal product in any country in the World
legalBasisΣ
0..1CodeableConceptThe legal framework against which this authorization is granted
jurisdictionalAuthorizationΣ
0..*BackboneElementAuthorization in areas within a country
identifierΣ
0..*IdentifierThe assigned number for the marketing authorization
countryΣ
0..1CodeableConceptCountry of authorization
jurisdictionΣ
0..*CodeableConceptJurisdiction within a country
legalStatusOfSupplyΣ
0..1CodeableConceptThe legal status of supply in a jurisdiction or region
validityPeriodΣ
0..1PeriodThe start and expected end date of the authorization
holderΣ
0..1Reference(Organization)Marketing Authorization Holder
regulatorΣ
0..1Reference(Organization)Medicines Regulatory Agency
procedureΣ
0..1BackboneElementThe regulatory procedure for granting or amending a marketing authorization
identifierΣ
0..1IdentifierIdentifier for this procedure
typeRequiredΣ
1..1CodeableConceptType of procedure
date[x]Σ
0..1Period | dateTimeDate of procedure
applicationΣ
0..*Same as MedicinalProductAuthorization.procedureApplcations 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.

ParameterTypeDescriptionPGES
countrytoken

The country in which the marketing authorization has been granted

MedicinalProductAuthorization.country
holderreference

Marketing Authorization Holder

MedicinalProductAuthorization.holder
identifiertoken

Business identifier for the marketing authorization, as assigned by a regulator

MedicinalProductAuthorization.identifier
statustoken

The status of the marketing authorization

MedicinalProductAuthorization.status
subjectreference

The medicinal product that is being authorized

MedicinalProductAuthorization.subject

PG: PostgreSQL, ES: Elasticsearch. passes its TestScript checks, fails, not tested yet.

Common parameters on every resource (8)
_haste-health-authorreference

The author of the resource

_idtoken

Logical id of this artifact

_lastUpdateddate

When the resource version last changed

_profileuri

Profiles this resource claims to conform to

_securitytoken

Security Labels applied to this resource

_sourceuri

Identifies where the resource comes from

_tagtoken

Tags applied to this resource

_typetoken

Derived from the R4B Definition