identifier | Identifier | 0..* | Business identifier for this product. Could be an MPID |
type | CodeableConcept | 0..1 | Regulatory type, e.g. Investigational or Authorized |
domain | Coding | 0..1 | If this medicine applies to human or veterinary uses |
combinedPharmaceuticalDoseForm | CodeableConcept | 0..1 | The dose form for a single part product, or combined form of a multiple part product |
legalStatusOfSupply | CodeableConcept | 0..1 | The legal status of supply of the medicinal product as classified by the regulator |
additionalMonitoringIndicator | CodeableConcept | 0..1 | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons |
specialMeasures | string | 0..* | Whether the Medicinal Product is subject to special measures for regulatory reasons |
paediatricUseIndicator | CodeableConcept | 0..1 | If authorised for use in children |
productClassification | CodeableConcept | 0..* | Allows the product to be classified by various systems |
marketingStatus | MarketingStatus | 0..* | Marketing status of the medicinal product, in contrast to marketing authorizaton |
pharmaceuticalProduct | Reference | 0..* | Pharmaceutical aspects of product |
packagedMedicinalProduct | Reference | 0..* | Package representation for the product |
attachedDocument | Reference | 0..* | Supporting documentation, typically for regulatory submission |
masterFile | Reference | 0..* | A master file for to the medicinal product (e.g. Pharmacovigilance System Master File) |
contact | Reference | 0..* | A product specific contact, person (in a role), or an organization |
clinicalTrial | Reference | 0..* | Clinical trials or studies that this product is involved in |
name | BackboneElement | 1..* | The product's name, including full name and possibly coded parts |
crossReference | Identifier | 0..* | Reference to another product, e.g. for linking authorised to investigational product |
manufacturingBusinessOperation | BackboneElement | 0..* | An operation applied to the product, for manufacturing or adminsitrative purpose |
specialDesignation | BackboneElement | 0..* | Indicates if the medicinal product has an orphan designation for the treatment of a rare disease |