MedicinalProductDefinition
The global medicinal product as authorised on the market: brand, MA, indications, regulatory constraints. The pivot resource of ISO IDMP submissions on the FHIR side.
Purpose
MedicinalProductDefinition represents a drug at the marketing/regulatory level: marketing authorisation, validated indications, status. It bridges to the more granular resources (AdministrableProductDefinition, PackagedProductDefinition, ManufacturedItemDefinition, Ingredient) to model the full product in its ISO IDMP regulatory complexity.
Key elements
| Field | Type | Cardinality | Role |
|---|---|---|---|
identifier | Identifier[] | 0..* | Identifiers (EMA MPID, FDA NDC, ANSM CIS). |
type | CodeableConcept | 0..1 | Type (drug, combined device). |
domain | CodeableConcept | 0..1 | Domain (human, veterinary). |
version | string | 0..1 | Commercial version. |
status | CodeableConcept | 0..1 | Status (active, authorized, withdrawn). |
description | markdown | 0..1 | Free-text description. |
name | BackboneElement[] | 1..* | Names (brand, INN, commercial). |
classification | CodeableConcept[] | 0..* | ATC, EPC classification. |
marketingStatus | MarketingStatus[] | 0..* | Per-country marketing status. |
route | CodeableConcept[] | 0..* | Approved routes. |
JSON example
{
"resourceType": "MedicinalProductDefinition",
"id": "aspirin-300",
"identifier": [{
"system": "https://spor.ema.europa.eu/pmswi/",
"value": "MPID-EU-12345"
}],
"type": {
"coding": [{
"system": "http://hl7.org/fhir/medicinal-product-type",
"code": "MedicinalProduct"
}]
},
"domain": {
"coding": [{
"system": "http://hl7.org/fhir/medicinal-product-domain",
"code": "Human"
}]
},
"status": {
"coding": [{
"system": "http://hl7.org/fhir/publication-status",
"code": "active"
}]
},
"name": [{
"productName": "Aspirine 300mg, comprimé",
"type": {
"coding": [{
"system": "http://terminology.hl7.org/CodeSystem/medicinal-product-name-type",
"code": "BAN",
"display": "British Approved Name"
}]
}
}],
"classification": [{
"coding": [{
"system": "http://www.whocc.no/atc",
"code": "B01AC06",
"display": "Acetylsalicylic acid"
}]
}]
}Common pitfalls
- Confusing MedicinalProductDefinition (regulatory) with Medication (clinical use).
- No MPID/NDC/CIS identifier: isolated product, not interoperable with regulatory bases.
- Status withdrawn without Period: impossible to know when the product was withdrawn.
Related resources
- administrableproductdefinition — administrable form.
- packagedproductdefinition — packaging.
- ingredient — composition.
- clinicalusedefinition — indications, contra-indications.
- regulatedauthorization — marketing authorisation.