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 |