RegulatedAuthorization
A regulatory authorisation: drug MA, device CE marking, facility accreditation. The FHIR envelope for regulatory decisions.
Purpose
RegulatedAuthorization wraps the regulatory decision that legalises a product: marketing authorisation (EMA, FDA, ANSM), device CE marking, HAS accreditation, clinical trial approvals. The resource carries the issuing authority, identifier, date, territorial scope and attached conditions.
Key elements
| Field | Type | Cardinality | Role |
|---|---|---|---|
identifier | Identifier[] | 0..* | Authorisation identifiers. |
subject | Reference(MedicinalProductDefinition | BiologicallyDerivedProduct | NutritionProduct | PackagedProductDefinition | Ingredient | SubstanceDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition | Practitioner | Organization)[] | 0..* | Authorisation subject. |
type | CodeableConcept | 0..1 | Authorisation type. |
description | markdown | 0..1 | Description. |
region | CodeableConcept[] | 0..* | Covered territories. |
status | CodeableConcept | 0..1 | Status. |
statusDate | dateTime | 0..1 | Status date. |
validityPeriod | Period | 0..1 | Validity period. |
indication | CodeableReference[] | 0..* | Authorised indications. |
holder | Reference(Organization) | 0..1 | Holder. |
regulator | Reference(Organization) | 0..1 | Issuing authority. |
JSON example
{
"resourceType": "RegulatedAuthorization",
"id": "example-amm-aspirin",
"identifier": [{
"system": "https://ansm.sante.fr/amm",
"value": "AMM-2010-A-12345"
}],
"subject": [{
"reference": "MedicinalProductDefinition/aspirin-300"
}],
"type": {
"coding": [{
"system": "http://hl7.org/fhir/regulated-authorization-type",
"code": "MarketingAuth"
}]
},
"region": [{
"coding": [{
"system": "urn:iso:std:iso:3166",
"code": "FR"
}]
}],
"status": {
"coding": [{
"system": "http://hl7.org/fhir/publication-status",
"code": "active"
}]
},
"statusDate": "2010-06-15",
"validityPeriod": {
"start": "2010-06-15"
},
"holder": {
"reference": "Organization/bayer-fr"
},
"regulator": {
"reference": "Organization/ansm"
}
}Common pitfalls
- No region: 'world-wide' authorisation is suspicious, avoid.
- Holder vs regulator confused: holder = MA holder, regulator = authority.
- Type='MarketingAuth' used for a clinical trial: wrong code, prefer 'ClinicalTrialAuth'.
Related resources
- medicinalproductdefinition — authorised product.
- packagedproductdefinition — packaging.
- organization — authority or holder.
- researchstudy — clinical trial.