MedicinalProductAuthorization - FHIR Resource (r4)
This MedicinalProductAuthorization Resource uses the FHIR API standard for access and structure.
Validate an MedicinalProductAuthorization FHIR Resource (r4)
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
MedicinalProductAuthorization Example
{
"resourceType": "MedicinalProductAuthorization",
"id": "example",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative with Details</b></p><p><b>id</b>: example</p><p><b>identifier</b>: EU/1/11/999/001</p><p><b>country</b>: EU <span>(Details : {http://ema.europa.eu/example/country code 'EU' = 'EU)</span></p><p><b>status</b>: active <span>(Details : {http://ema.europa.eu/example/authorisationstatus code 'active' = 'active)</span></p><p><b>statusDate</b>: 14/01/2015</p><p><b>validityPeriod</b>: 16/08/2015 --> 20/05/2020</p><p><b>dataExclusivityPeriod</b>: 15/08/2010 --> 15/08/2020</p><p><b>dateOfFirstAuthorization</b>: 15/08/2010</p><p><b>internationalBirthDate</b>: 15/08/2010</p><blockquote><p><b>jurisdictionalAuthorization</b></p><p><b>identifier</b>: 123-456-789</p><p><b>country</b>: NO <span>(Details : {http://ema.europa.eu/example/countryCode code 'NO' = 'NO)</span></p></blockquote><blockquote><p><b>jurisdictionalAuthorization</b></p><p><b>identifier</b>: 123-456-123</p><p><b>country</b>: NO <span>(Details : {http://ema.europa.eu/example/countryCode code 'NO' = 'NO)</span></p></blockquote><p><b>holder</b>: <a>Organization/example</a></p><p><b>regulator</b>: <a>Organization/example</a></p><blockquote><p><b>procedure</b></p><p><b>identifier</b>: EMEA/H/C/009999/IA/0099/G</p><p><b>type</b>: VariationTypeIA <span>(Details : {http://ema.europa.eu/example/marketingAuthorisationProcedureType code 'VariationTypeIA' = 'VariationTypeIA)</span></p><p><b>date</b>: 02/08/2015 --> 21/08/2015</p><h3>Applications</h3><table><tr><td>-</td></tr><tr><td>*</td></tr></table></blockquote></div>"
},
"identifier": [
{
"system": "http://ema.europa.eu/example/marketingAuthorisationNumber",
"value": "EU/1/11/999/001"
}
],
"country": [
{
"coding": [
{
"system": "http://ema.europa.eu/example/country",
"code": "EU"
}
]
}
],
"status": {
"coding": [
{
"system": "http://ema.europa.eu/example/authorisationstatus",
"code": "active"
}
]
},
"statusDate": "2015-01-14",
"validityPeriod": {
"start": "2015-08-16",
"end": "2020-05-20"
},
"dataExclusivityPeriod": {
"start": "2010-08-15",
"end": "2020-08-15"
},
"dateOfFirstAuthorization": "2010-08-15",
"internationalBirthDate": "2010-08-15",
"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"
}
]
}
}
],
"holder": {
"reference": "Organization/example"
},
"regulator": {
"reference": "Organization/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"
}
]
}
}MedicinalProductAuthorization Structure
{
"resourceType" : "MedicinalProductAuthorization",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : [{ Identifier }], // Business identifier for the marketing authorization, as assigned by a regulator
"subject" : { Reference(MedicinalProduct|MedicinalProductPackaged) }, // The medicinal product that is being authorized
"country" : [{ CodeableConcept }], // The country in which the marketing authorization has been granted
"jurisdiction" : [{ CodeableConcept }], // Jurisdiction within a country
"status" : { CodeableConcept }, // The status of the marketing authorization
"statusDate" : "<dateTime>", // The date at which the given status has become applicable
"restoreDate" : "<dateTime>", // The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored
"validityPeriod" : { 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
"dataExclusivityPeriod" : { Period }, // A period of time after authorization before generic product applicatiosn can be submitted
"dateOfFirstAuthorization" : "<dateTime>", // The date when the first authorization was granted by a Medicines Regulatory Agency
"internationalBirthDate" : "<dateTime>", // Date of first marketing authorization for a company's new medicinal product in any country in the World
"legalBasis" : { CodeableConcept }, // The legal framework against which this authorization is granted
"jurisdictionalAuthorization" : [{ // Authorization in areas within a country
"identifier" : [{ Identifier }], // The assigned number for the marketing authorization
"country" : { CodeableConcept }, // Country of authorization
"jurisdiction" : [{ CodeableConcept }], // Jurisdiction within a country
"legalStatusOfSupply" : { CodeableConcept }, // The legal status of supply in a jurisdiction or region
"validityPeriod" : { Period } // The start and expected end date of the authorization
}],
"holder" : { Reference(Organization) }, // Marketing Authorization Holder
"regulator" : { Reference(Organization) }, // Medicines Regulatory Agency
"procedure" : { // The regulatory procedure for granting or amending a marketing authorization
"identifier" : { Identifier }, // Identifier for this procedure
"type" : { CodeableConcept }, // R! Type of procedure
// date[x]: Date of procedure. One of these 2:
"datePeriod" : { Period },
"dateDateTime" : "<dateTime>",
"application" : [{ Content as for MedicinalProductAuthorization.procedure }] // Applcations submitted to obtain a marketing authorization
}
}
MedicinalProductAuthorization Search Parameters
The following search parameters can be used to query MedicinalProductAuthorization resources. Just submit them like so:
https://api.1up.health/fhir/r4/MedicinalProductAuthorization?query-param=queryvalue| Search Parameter | Field Type | Resource Fields Searched |
|---|---|---|
country | text | country |
holder | reference | holder |
identifier | text | identifier |
status | text | status |
subject | reference | subject |
