This page is part of the FHIR Specification (v3.3.0: R4 Ballot 2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
Biomedical Research and Regulation Work Group | Maturity Level: 0 | Draft | Compartments: Not linked to any defined compartments |
Detailed Descriptions for the elements in the MedicinalProduct resource.
| MedicinalProduct | |
| Element Id | MedicinalProduct |
| Definition | Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use). |
| Control | 1..1 |
| Summary | true |
| MedicinalProduct.identifier | |
| Element Id | MedicinalProduct.identifier |
| Definition | Business idenfifier for this product. Could be an MPID. |
| Note | This is a business identifer, not a resource identifier (see discussion) |
| Control | 1..1 |
| Type | Identifier |
| Alternate Names | MPID |
| Summary | true |
| MedicinalProduct.type | |
| Element Id | MedicinalProduct.type |
| Definition | Regulatory type, e.g. Investigational or Authorized. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.combinedPharmaceuticalDoseForm | |
| Element Id | MedicinalProduct.combinedPharmaceuticalDoseForm |
| Definition | The dose form for a single part product, or combined form of a multiple part product. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.additionalMonitoringIndicator | |
| Element Id | MedicinalProduct.additionalMonitoringIndicator |
| Definition | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.specialMeasures | |
| Element Id | MedicinalProduct.specialMeasures |
| Definition | Whether the Medicinal Product is subject to special measures for regulatory reasons. |
| Control | 0..* |
| Type | string |
| Summary | true |
| MedicinalProduct.paediatricUseIndicator | |
| Element Id | MedicinalProduct.paediatricUseIndicator |
| Definition | If authorised for use in children. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.orphanDesignationStatus | |
| Element Id | MedicinalProduct.orphanDesignationStatus |
| Definition | Indicates if the medicinal product has an orphan designation for the treatment of a rare disease. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.productClassification | |
| Element Id | MedicinalProduct.productClassification |
| Definition | Allows the product to be classified by various systems. |
| Control | 0..* |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.marketingAuthorization | |
| Element Id | MedicinalProduct.marketingAuthorization |
| Definition | Product regulatory authorization. |
| Control | 0..1 |
| Type | Reference(MedicinalProductAuthorization) |
| Summary | true |
| MedicinalProduct.packagedMedicinalProduct | |
| Element Id | MedicinalProduct.packagedMedicinalProduct |
| Definition | Package representation for the product. |
| Control | 0..* |
| Type | Reference(MedicinalProductPackaged) |
| Summary | true |
| MedicinalProduct.pharmaceuticalProduct | |
| Element Id | MedicinalProduct.pharmaceuticalProduct |
| Definition | Pharmaceutical aspects of product. |
| Control | 0..* |
| Type | Reference(MedicinalProductPharmaceutical) |
| Summary | true |
| MedicinalProduct.clinicalParticulars | |
| Element Id | MedicinalProduct.clinicalParticulars |
| Definition | Clinical particulars, indications etc. |
| Control | 0..* |
| Type | Reference(MedicinalProductClinicals) |
| Summary | true |
| MedicinalProduct.attachedDocument | |
| Element Id | MedicinalProduct.attachedDocument |
| Definition | Supporting documentation, typically for regulatory submission. |
| Control | 0..* |
| Type | Reference(DocumentReference) |
| Summary | true |
| MedicinalProduct.masterFile | |
| Element Id | MedicinalProduct.masterFile |
| Definition | A master file for to the medicinal product (e.g. Pharmacovigilance System Master File). |
| Control | 0..* |
| Type | Reference(DocumentReference) |
| Summary | true |
| MedicinalProduct.name | |
| Element Id | MedicinalProduct.name |
| Definition | The product's name, including full name and possibly coded parts. |
| Control | 1..* |
| Summary | true |
| MedicinalProduct.name.fullName | |
| Element Id | MedicinalProduct.name.fullName |
| Definition | The full product name. |
| Control | 1..1 |
| Type | string |
| Summary | true |
| MedicinalProduct.name.namePart | |
| Element Id | MedicinalProduct.name.namePart |
| Definition | Coding words or phrases of the name. |
| Control | 0..* |
| Summary | true |
| MedicinalProduct.name.namePart.part | |
| Element Id | MedicinalProduct.name.namePart.part |
| Definition | A fragment of a product name. |
| Control | 1..1 |
| Type | string |
| Summary | true |
| MedicinalProduct.name.namePart.type | |
| Element Id | MedicinalProduct.name.namePart.type |
| Definition | Idenifying type for this part of the name (e.g. strength part). |
| Control | 1..1 |
| Type | Coding |
| Summary | true |
| MedicinalProduct.name.countryLanguage | |
| Element Id | MedicinalProduct.name.countryLanguage |
| Definition | Country where the name applies. |
| Control | 0..* |
| Summary | true |
| MedicinalProduct.name.countryLanguage.country | |
| Element Id | MedicinalProduct.name.countryLanguage.country |
| Definition | Country code for where this name applies. |
| Control | 1..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.name.countryLanguage.jurisdiction | |
| Element Id | MedicinalProduct.name.countryLanguage.jurisdiction |
| Definition | Jurisdiction code for where this name applies. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.name.countryLanguage.language | |
| Element Id | MedicinalProduct.name.countryLanguage.language |
| Definition | Language code for this name. |
| Control | 1..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.crossReference | |
| Element Id | MedicinalProduct.crossReference |
| Definition | Reference to another product, e.g. for linking authorised to investigational product. |
| Control | 0..* |
| Type | Identifier |
| Summary | true |
| MedicinalProduct.manufacturingBusinessOperation | |
| Element Id | MedicinalProduct.manufacturingBusinessOperation |
| Definition | An operation applied to the product, for manufacturing or adminsitrative purpose. |
| Control | 0..* |
| Summary | true |
| MedicinalProduct.manufacturingBusinessOperation.operationType | |
| Element Id | MedicinalProduct.manufacturingBusinessOperation.operationType |
| Definition | The type of manufacturing operation. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber | |
| Element Id | MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber |
| Definition | Regulatory authorization reference number. |
| Control | 0..1 |
| Type | Identifier |
| Summary | true |
| MedicinalProduct.manufacturingBusinessOperation.effectiveDate | |
| Element Id | MedicinalProduct.manufacturingBusinessOperation.effectiveDate |
| Definition | Regulatory authorization date. |
| Control | 0..1 |
| Type | dateTime |
| Summary | true |
| MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator | |
| Element Id | MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator |
| Definition | To indicate if this proces is commercially confidential. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.manufacturingBusinessOperation.manufacturer | |
| Element Id | MedicinalProduct.manufacturingBusinessOperation.manufacturer |
| Definition | The manufacturer or establishment associated with the process. |
| Control | 0..* |
| Type | Reference(Organization) |
| Summary | true |
| MedicinalProduct.manufacturingBusinessOperation.regulator | |
| Element Id | MedicinalProduct.manufacturingBusinessOperation.regulator |
| Definition | A regulator which oversees the operation. |
| Control | 0..1 |
| Type | Reference(Organization) |
| Summary | true |