http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|5.0.0
Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use, drug catalogs, to support prescribing, adverse events management etc.).
| Name | Flags | Card | Type | Description & Constraints |
|---|---|---|---|---|
MedicinalProductDefinition | 0..* | Detailed definition of a medicinal product | ||
Σ | 0..* | Identifier | Business identifier for this product. Could be an MPID | |
Σ | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized MedicinalProductType (example) | |
Σ | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses MedicinalProductType (example) | |
Σ | 0..1 | string | A business identifier relating to a specific version of the product | |
?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record PublicationStatus (preferred) | |
Σ | 0..1 | dateTime | The date at which the given status became applicable | |
Σ | 0..1 | markdown | General description of this product | |
Σ | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product CombinedDoseForm (example) | |
Σ | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body SNOMEDCTRouteCodes (example) | |
Σ | 0..1 | markdown | Description of indication(s) for this product, used when structured indications are not required | |
Σ | 0..1 | CodeableConcept | The legal status of supply of the medicinal product as classified by the regulator LegalStatusOfSupply (example) | |
Σ | 0..1 | CodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons AdditionalMonitoring (example) | |
Σ | 0..* | CodeableConcept | Whether the Medicinal Product is subject to special measures for regulatory reasons SpecialMeasures (example) | |
Σ | 0..1 | CodeableConcept | If authorised for use in children PediatricUse (example) | |
Σ | 0..* | CodeableConcept | Allows the product to be classified by various systems ProductClassification (example) | |
Σ | 0..* | MarketingStatus | Marketing status of the medicinal product, in contrast to marketing authorization | |
Σ | 0..* | CodeableConcept | Package type for the product MedicinalProductPackageType (example) | |
Σ | 0..* | Reference | Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes | |
Σ | 0..* | CodeableConcept | The ingredients of this medicinal product - when not detailed in other resources SNOMEDCTSubstanceCodes (example) | |
Σ | 0..* | CodeableReference | Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product SNOMEDCTSubstanceCodes (example) | |
Σ | 0..* | Reference | Additional documentation about the medicinal product | |
Σ | 0..* | Reference | A master file for the medicinal product (e.g. Pharmacovigilance System Master File) | |
Σ | 0..* | BackboneElement | A product specific contact, person (in a role), or an organization | |
Σ | 0..1 | CodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information ProductContactType (example) | |
Σ | 1..1 | Reference | A product specific contact, person (in a role), or an organization | |
Σ | 0..* | Reference | Clinical trials or studies that this product is involved in | |
Σ | 0..* | Coding | A code that this product is known by, within some formal terminology MedicationFormalRepresentation (example) | |
Σ | 1..* | BackboneElement | The product's name, including full name and possibly coded parts | |
Σ | 1..1 | string | The full product name | |
Σ | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary ProductNameType (example) | |
Σ | 0..* | BackboneElement | Coding words or phrases of the name | |
Σ | 1..1 | string | A fragment of a product name | |
Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) ProductNamePartType (example) | |
Σ | 0..* | BackboneElement | Country and jurisdiction where the name applies | |
Σ | 1..1 | CodeableConcept | Country code for where this name applies Country (example) | |
Σ | 0..1 | CodeableConcept | Jurisdiction code for where this name applies Jurisdiction (example) | |
Σ | 1..1 | CodeableConcept | Language code for this name Language (required) | |
Σ | 0..* | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product | |
Σ | 1..1 | CodeableReference | Reference to another product, e.g. for linking authorised to investigational product | |
Σ | 0..1 | CodeableConcept | The type of relationship, for instance branded to generic or virtual to actual product ProductCrossReferenceType (example) | |
Σ | 0..* | BackboneElement | A manufacturing or administrative process for the medicinal product | |
Σ | 0..1 | CodeableReference | The type of manufacturing operation e.g. manufacturing itself, re-packaging | |
Σ | 0..1 | Period | Date range of applicability | |
Σ | 0..* | Reference | The organization responsible for the particular process, e.g. the manufacturer or importer | |
Σ | 0..1 | CodeableConcept | Specifies whether this process is considered proprietary or confidential ProductConfidentiality (example) | |
Σ | 0..* | BackboneElement | Key product features such as \"sugar free\", \"modified release\" | |
Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic ProductCharacteristic (example) | |
Σ | 0..1 | A value for the characteristic | ||
Σ | 0..1 | CodeableConcept | ||
Σ | 0..1 | markdown | ||
Σ | 0..1 | Quantity | ||
Σ | 0..1 | integer | ||
Σ | 0..1 | date | ||
Σ | 0..1 | boolean | ||
Σ | 0..1 | Attachment |