MedicinalProductDefinition — detail: IDMP
FHIR modelling of the pharmaceutical product as defined by the ISO IDMP standard. Product level (SmPC-level): commercial name, legal status, market authorisation.
IDMP ISO 11615 mapping
IDMP (Identification of Medicinal Products) is a family of ISO standards 11615-11616-11238-11239-11240 that defines a unified global drug reference. FHIR R5 implements IDMP through 8 coupled resources:
- MedicinalProductDefinition — SmPC-level product (ISO 11615).
- AdministrableProductDefinition — administrable form.
- ManufacturedItemDefinition — manufactured item.
- PackagedProductDefinition — packaging.
- Ingredient — active/excipient composition.
- SubstanceDefinition — pure substance (ISO 11238).
- ClinicalUseDefinition — indications, contraindications.
- RegulatedAuthorization — market authorisation.
MPID — global unique identifier
The MPID (Medicinal Product Identifier) is the ISO 11615 identifier assigned by the EMA via the SPOR system (Substances, Products, Organisations and Referentials) in Europe. In France, the CIS (Code Identifiant de Spécialité) from ANSM is the national equivalent.
Key fields
type—MedicinalProduct | InvestigationalProduct | TherapyForBlind | TissueProduct | Vaccine.domain— Human / Veterinary.status— Publication status.legalStatusOfSupply— OTC / prescription / hospital-only.name— commercial name with country and language.classification— ATC, therapeutic code.marketingStatus— marketed / withdrawn.
Example: Doliprane 500mg tablet
{
"resourceType": "MedicinalProductDefinition",
"id": "doliprane-500mg-comp",
"identifier": [{
"system": "http://spor.ema.europa.eu/v1/medicinalproducts",
"value": "100000123456"
}, {
"system": "http://fhir.fr/CodeSystem/cis",
"value": "CIS-65142359"
}],
"type": {
"coding": [{
"system": "http://terminology.hl7.org/CodeSystem/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"
}]
},
"legalStatusOfSupply": {
"coding": [{
"system": "http://hl7.org/fhir/legal-status-of-supply",
"code": "otc",
"display": "OTC"
}]
},
"name": [{
"productName": "Doliprane 500 mg, tablet",
"type": {
"coding": [{
"system": "http://terminology.hl7.org/CodeSystem/medicinal-product-name-part-type",
"code": "FullName"
}]
},
"usage": [{
"country": { "coding": [{ "system": "urn:iso:std:iso:3166", "code": "FR" }] },
"language": { "coding": [{ "system": "urn:ietf:bcp:47", "code": "fr" }] }
}]
}]
}Common pitfalls
- Confusion with Medication — Medication is used clinically (MedicationRequest, MedicationDispense). MedicinalProductDefinition is the regulatory reference.
- Missing MPID — EMA requires MPID + PhPID + SubID for ePI submissions.
- Name without country/language — a single product can have different names per country (Tylenol US, Doliprane FR, Panadol UK).