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ManufacturedItemDefinition — Manufactured drug unit

The physical object coming out of the pharmaceutical factory before packaging: tablet, capsule, ampoule, pre-filled device. A central link in the IDMP chain (ISO 11615 / 11616 / 11238 / 11239 / 11240).

Purpose of the resource

ManufacturedItemDefinition represents the individually produced item from the manufacturer, before packaging into a carton (PackagedProductDefinition) or administration (AdministrableProductDefinition). It is the finest grain of the FHIR medication catalogue: a paracetamol 500 mg capsule, a 5 mL ampoule of injectable amoxicillin, a 10 mg amlodipine film-coated tablet.

The IDMP scope (Identification of Medicinal Products) derived from ISO requires this granularity for pharmacovigilance, supply chain and cross-border signalling.

Key fields

FieldTypeCardinalityRole
identifierIdentifier[]0..*Regulator identifiers (EMA MI ID, FDA ID…).
statuscode1..1draft | active | retired | unknown.
namestring0..1Human-readable designation (composition, strength, form).
manufacturedDoseFormCodeableConcept1..1Manufactured dose form (EDQM Standard Terms).
unitOfPresentationCodeableConcept0..1Presentation unit (capsule, tablet, mL).
manufacturerReference(Organization)[]0..*Manufacturers.
marketingStatusMarketingStatus[]0..*Marketing status in each jurisdiction.
ingredientCodeableConcept[]0..*Components (reference to Ingredient).
propertyBackboneElement[]0..*Characteristic properties (colour, marking, dimensions).
componentBackboneElement[]0..*Physical components (capsule + content, bi-layer tablet).

JSON example

json manufactureditemdefinition-example.json 
{
  "resourceType": "ManufacturedItemDefinition",
  "id": "example",
  "identifier": [{
    "system": "http://ema.europa.eu/fhir/manufacturedItemId",
    "value": "MI-001-EU"
  }],
  "status": "active",
  "name": "Capsule, Hard 100 mg",
  "manufacturedDoseForm": {
    "coding": [{
      "system": "http://standardterms.edqm.eu",
      "code": "10221000",
      "display": "Capsule, hard"
    }]
  },
  "unitOfPresentation": {
    "coding": [{
      "system": "http://standardterms.edqm.eu",
      "code": "15054000",
      "display": "Capsule"
    }]
  },
  "manufacturer": [{
    "reference": "Organization/example-manufacturer"
  }]
}

Position in IDMP

The IDMP chain in FHIR R5 wires seven resources together:

  • MedicinalProductDefinition — medicinal product (marketing authorisation).
  • PackagedProductDefinition — commercial packaging.
  • ManufacturedItemDefinition — produced unit (our resource).
  • AdministrableProductDefinition — form administered to the patient.
  • Ingredient — active substance or excipient.
  • SubstanceDefinition — chemical definition of the substance.
  • ClinicalUseDefinition — indications, contraindications, interactions.

Common pitfalls

  • Non-normalised EDQM form — manufacturedDoseForm must use the EDQM Standard Terms vocabulary.
  • Confusion with AdministrableProductDefinition — manufactured = out of the factory; administrable = form received by the patient (after dilution, for example).
  • Multiple component entries without role — when a product has a capsule shell + content, make the nature of each component explicit.