MedicinalProductAuthorization.regulator
FHIR attribute (r4)
In the MedicinalProductAuthorization resource for FHIR r4 , the regulator attribute identifies the Medicines Regulatory Agency
regulator (MedicinalProductAuthorization) description
Resource Type: MedicinalProductAuthorization
Attribute Name: regulator
Description: Medicines Regulatory Agency
FHIR Version: r4
Attribute Type : Reference
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
MedicinalProductAuthorization.regulator Example
"regulator": {
"reference": "Organization/example"
}MedicinalProductAuthorization attributes
AttributeField is listTypeDescription
Description: Business identifier for the marketing authorization, as assigned by a regulator
FHIR Version: r4
Attribute Type : Identifier
Required: N/A
Countability: Array
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"identifier": [
{
"system": "http://ema.europa.eu/example/marketingAuthorisationNumber",
"value": "EU/1/11/999/001"
}
]Learn more about the (MedicinalProductAuthorization) identifier FHIR attribute
Description: The medicinal product that is being authorized
FHIR Version: r4
Attribute Type : Reference
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"subject": Learn more about the (MedicinalProductAuthorization) subject FHIR attribute
Description: The country in which the marketing authorization has been granted
FHIR Version: r4
Attribute Type : CodeableConcept
Required: N/A
Countability: Array
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"country": [
{
"coding": [
{
"system": "http://ema.europa.eu/example/country",
"code": "EU"
}
]
}
]Learn more about the (MedicinalProductAuthorization) country FHIR attribute
Description: Jurisdiction within a country
FHIR Version: r4
Attribute Type : CodeableConcept
Required: N/A
Countability: Array
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"jurisdiction": Learn more about the (MedicinalProductAuthorization) jurisdiction FHIR attribute
Description: The status of the marketing authorization
FHIR Version: r4
Attribute Type : CodeableConcept
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"status": {
"coding": [
{
"system": "http://ema.europa.eu/example/authorisationstatus",
"code": "active"
}
]
}Learn more about the (MedicinalProductAuthorization) status FHIR attribute
Description: The date at which the given status has become applicable
FHIR Version: r4
Attribute Type : dateTime
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"statusDate": "2015-01-14"Learn more about the (MedicinalProductAuthorization) statusDate FHIR attribute
Description: The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored
FHIR Version: r4
Attribute Type : dateTime
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"restoreDate": Learn more about the (MedicinalProductAuthorization) restoreDate FHIR attribute
Description: 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
FHIR Version: r4
Attribute Type : Period
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"validityPeriod": {
"start": "2015-08-16",
"end": "2020-05-20"
}Learn more about the (MedicinalProductAuthorization) validityPeriod FHIR attribute
Description: A period of time after authorization before generic product applicatiosn can be submitted
FHIR Version: r4
Attribute Type : Period
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"dataExclusivityPeriod": {
"start": "2010-08-15",
"end": "2020-08-15"
}Learn more about the (MedicinalProductAuthorization) dataExclusivityPeriod FHIR attribute
Description: The date when the first authorization was granted by a Medicines Regulatory Agency
FHIR Version: r4
Attribute Type : dateTime
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"dateOfFirstAuthorization": "2010-08-15"Learn more about the (MedicinalProductAuthorization) dateOfFirstAuthorization FHIR attribute
Description: Date of first marketing authorization for a company's new medicinal product in any country in the World
FHIR Version: r4
Attribute Type : dateTime
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"internationalBirthDate": "2010-08-15"Learn more about the (MedicinalProductAuthorization) internationalBirthDate FHIR attribute
Description: The legal framework against which this authorization is granted
FHIR Version: r4
Attribute Type : CodeableConcept
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"legalBasis": Learn more about the (MedicinalProductAuthorization) legalBasis FHIR attribute
Description: Authorization in areas within a country
FHIR Version: r4
Attribute Type : Data Type
Required: N/A
Countability: Array
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"jurisdictionalAuthorization": [
{
"id": "1",
"identifier": [
{
"system": "http://ema.europa.eu/example/marketingauthorisationnumber",
"value": "123-456-789"
}
],
"country": {
"coding": [
{
"system": "http://ema.europa.eu/example/countryCode",
"code": "NO"
}
]
}
},
{
"id": "2",
"identifier": [
{
"system": "http://ema.europa.eu/example/marketingauthorisationnumber",
"value": "123-456-123"
}
],
"country": {
"coding": [
{
"system": "http://ema.europa.eu/example/countryCode",
"code": "NO"
}
]
}
}
]Learn more about the (MedicinalProductAuthorization) jurisdictionalAuthorization FHIR attribute
Description: Marketing Authorization Holder
FHIR Version: r4
Attribute Type : Reference
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"holder": {
"reference": "Organization/example"
}Learn more about the (MedicinalProductAuthorization) holder FHIR attribute
Description: Medicines Regulatory Agency
FHIR Version: r4
Attribute Type : Reference
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"regulator": {
"reference": "Organization/example"
}Learn more about the (MedicinalProductAuthorization) regulator FHIR attribute
Description: The regulatory procedure for granting or amending a marketing authorization
FHIR Version: r4
Attribute Type : Data Type
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"procedure": {
"identifier": {
"system": "http://ema.europa.eu/example/procedureidentifier-number",
"value": "EMEA/H/C/009999/IA/0099/G"
},
"type": {
"coding": [
{
"system": "http://ema.europa.eu/example/marketingAuthorisationProcedureType",
"code": "VariationTypeIA"
}
]
},
"datePeriod": {
"start": "2015-08-02",
"end": "2015-08-21"
},
"application": [
{
"identifier": {
"system": "http://ema.europa.eu/example/applicationidentifier-number",
"value": "IA38G"
},
"type": {
"coding": [
{
"system": "http://ema.europa.eu/example/marketingAuthorisationApplicationType",
"code": "GroupTypeIAVariationNotification"
}
]
},
"dateDateTime": "2015-08-01"
}
]
}Learn more about the (MedicinalProductAuthorization) procedure FHIR attribute
