MedicinalProductAuthorization

Draft Other

The regulatory authorization of a medicinal product.

Endpoints

alphahttps://api.dev.ovok.com/fhir/R4/MedicinalProductAuthorization

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(s)	Cardinality	Description
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
_compartment	string
_count	string	https://www.hl7.org/fhir/search.html#_count
_elements	string	https://www.hl7.org/fhir/search.html#_elements
_id	string
_lastUpdated	string
_profile	string
_security	string
_sort	string	https://www.hl7.org/fhir/search.html#_sort
_source	string
_summary	string	https://www.hl7.org/fhir/search.html#_summary
_tag	string
_total	string	https://www.hl7.org/fhir/search.html#_total
country	string	http://hl7.org/fhir/SearchParameter/MedicinalProductAuthorization-country
holder	string	http://hl7.org/fhir/SearchParameter/MedicinalProductAuthorization-holder
identifier	string	http://hl7.org/fhir/SearchParameter/MedicinalProductAuthorization-identifier
status	string	http://hl7.org/fhir/SearchParameter/MedicinalProductAuthorization-status
subject	string	http://hl7.org/fhir/SearchParameter/MedicinalProductAuthorization-subject

Reference

• Official FHIR R4 spec: MedicinalProductAuthorization
• Maturity: Draft (FMM 0).