R6 Ballot (2nd Draft)

Publish-box (todo)

Example MedicinalProductDefinition/drug-and-device-complete (JSON)

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: No defined compartments

Raw JSON (canonical form + also see JSON Format Specification)

A powder and solution for injection that comes with a syringe in the pack (complete example)

{
  "resourceType" : "MedicinalProductDefinition",
  "id" : "drug-and-device-complete",
  "contained" : [{
    "resourceType" : "PackagedProductDefinition",
    "id" : "package",
    "packageFor" : [{
      "reference" : "#"
    }],
    "packaging" : {
      "packaging" : [{
        "type" : {
          "coding" : [{
            "code" : "cardboard box (outer)"
          }]
        },
        "packaging" : [{
          "type" : {
            "coding" : [{
              "code" : "cardboard box (inner)"
            }]
          },
          "packaging" : [{
            "type" : {
              "coding" : [{
                "code" : "sachet"
              }]
            },
            "containedItem" : [{
              "item" : {
                "reference" : {
                  "reference" : "#powderItem"
                }
              },
              "amount" : {
                "value" : 5,
                "unit" : "g",
                "system" : "http://unitsofmeasure.org",
                "code" : "g"
              }
            }]
          },
          {
            "type" : {
              "coding" : [{
                "code" : "bottle"
              }]
            },
            "containedItem" : [{
              "item" : {
                "reference" : {
                  "reference" : "#solventItem"
                }
              },
              "amount" : {
                "value" : 20,
                "unit" : "ml",
                "system" : "http://unitsofmeasure.org",
                "code" : "mL"
              }
            }]
          }]
        },
        {
          "type" : {
            "coding" : [{
              "code" : "foil bag"
            }]
          },
          "containedItem" : [{
            "item" : {
              "reference" : {
                "reference" : "#syringeDevice"
              }
            },
            "amount" : {
              "value" : 1
            }
          }]
        }]
      }]
    }
  },
  {
    "resourceType" : "ManufacturedItemDefinition",
    "id" : "solventItem",
    "status" : "active",
    "manufacturedDoseForm" : {
      "coding" : [{
        "system" : "http://example.org.uk/fhir/doseform",
        "code" : "solvent for powder for injection"
      }]
    }
  },
  {
    "resourceType" : "ManufacturedItemDefinition",
    "id" : "powderItem",
    "status" : "active",
    "manufacturedDoseForm" : {
      "coding" : [{
        "system" : "http://example.org.uk/fhir/doseform",
        "code" : "powder for solution for injection"
      }]
    }
  },
  {
    "resourceType" : "DeviceDefinition",
    "id" : "syringeDevice",
    "classification" : [{
      "type" : {
        "text" : "syringe"
      }
    }]
  },
  {
    "resourceType" : "AdministrableProductDefinition",
    "id" : "administrable-form",
    "status" : "active",
    "formOf" : [{
      "reference" : "#"
    }],
    "administrableDoseForm" : {
      "coding" : [{
        "code" : "solution for injection"
      }]
    },
    "producedFrom" : [{
      "reference" : "#powderItem"
    },
    {
      "reference" : "#solventItem"
    }],
    "routeOfAdministration" : [{
      "code" : {
        "coding" : [{
          "system" : "http://example.org.uk/fhir/route",
          "code" : "intramuscular"
        }]
      }
    }]
  }],
  "identifier" : [{
    "system" : "http://example.org.uk/fhir/product",
    "value" : "Wonderdrug+"
  }],
  "combinedPharmaceuticalDoseForm" : {
    "coding" : [{
      "system" : "http://example.org.uk/fhir/doseform",
      "code" : "Powder and solution for injection with itegral syringe"
    }]
  },
  "name" : [{
    "productName" : "Wonderdrug liquid 20ml (integral syringe)"
  }]
}

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.