Name | Flags | Card. | Type | Description & Constraints![]() |
---|---|---|---|---|
ΣD | DomainResource | Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use) Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension | ||
Σ | 1..1 | Identifier | Business idenfifier for this product. Could be an MPID | |
Σ | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized | |
Σ | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product | |
Σ | 0..1 | CodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons | |
Σ | 0..* | string | Whether the Medicinal Product is subject to special measures for regulatory reasons | |
Σ | 0..1 | CodeableConcept | If authorised for use in children | |
Σ | 0..1 | CodeableConcept | Indicates if the medicinal product has an orphan designation for the treatment of a rare disease | |
Σ | 0..* | CodeableConcept | Allows the product to be classified by various systems | |
Σ | 0..1 | Reference(MedicinalProductAuthorization) | Product regulatory authorization | |
Σ | 0..* | Reference(MedicinalProductPackaged) | Package representation for the product | |
Σ | 0..* | Reference(MedicinalProductPharmaceutical) | Pharmaceutical aspects of product | |
Σ | 0..* | Reference(MedicinalProductClinicals) | Clinical particulars, indications etc. | |
Σ | 0..* | Reference(DocumentReference) | Supporting documentation, typically for regulatory submission | |
Σ | 0..* | Reference(DocumentReference) | A master file for to the medicinal product (e.g. Pharmacovigilance System Master File) | |
Σ | 1..* | BackboneElement | The product's name, including full name and possibly coded parts | |
Σ | 1..1 | string | The full product name | |
Σ | 0..* | BackboneElement | Coding words or phrases of the name | |
Σ | 1..1 | string | A fragment of a product name | |
Σ | 1..1 | Coding | Idenifying type for this part of the name (e.g. strength part) | |
Σ | 0..* | BackboneElement | Country where the name applies | |
Σ | 1..1 | CodeableConcept | Country code for where this name applies | |
Σ | 0..1 | CodeableConcept | Jurisdiction code for where this name applies | |
Σ | 1..1 | CodeableConcept | Language code for this name | |
Σ | 0..* | Identifier | Reference to another product, e.g. for linking authorised to investigational product | |
Σ | 0..* | BackboneElement | An operation applied to the product, for manufacturing or adminsitrative purpose | |
Σ | 0..1 | CodeableConcept | The type of manufacturing operation | |
Σ | 0..1 | Identifier | Regulatory authorization reference number | |
Σ | 0..1 | dateTime | Regulatory authorization date | |
Σ | 0..1 | CodeableConcept | To indicate if this proces is commercially confidential | |
Σ | 0..* | Reference(Organization) | The manufacturer or establishment associated with the process | |
Σ | 0..1 | Reference(Organization) | A regulator which oversees the operation | |
![]() |