MedicinalProduct
SpecializedDetailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use).
| Path | Card. | Type | Description & Constraints |
|---|---|---|---|
| MedicinalProduct | 0..* | — | Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use) |
| .idΣ | 0..1 | String | Logical id of this artifact |
| .metaΣ | 0..1 | Meta | Metadata about the resource |
| .implicitRules?!Σ | 0..1 | uri | A set of rules under which this content was created |
| .language | 0..1 | code | Language of the resource content Bindinglanguages(preferred) |
| .text | 0..1 | Narrative | Text summary of the resource, for human interpretation |
| .contained | 0..* | Resource | Contained, inline Resources |
| .extension | 0..* | Extension | Additional content defined by implementations |
| .modifierExtension?! | 0..* | Extension | Extensions that cannot be ignored |
| .identifierΣ | 0..* | Identifier | Business identifier for this product. Could be an MPID |
| .typeΣ | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized |
| .domainΣ | 0..1 | Coding | If this medicine applies to human or veterinary uses |
| .combinedPharmaceuticalDoseFormΣ | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product |
| .legalStatusOfSupplyΣ | 0..1 | CodeableConcept | The legal status of supply of the medicinal product as classified by the regulator |
| .additionalMonitoringIndicatorΣ | 0..1 | CodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons |
| .specialMeasuresΣ | 0..* | string | Whether the Medicinal Product is subject to special measures for regulatory reasons |
| .paediatricUseIndicatorΣ | 0..1 | CodeableConcept | If authorised for use in children |
| .productClassificationΣ | 0..* | CodeableConcept | Allows the product to be classified by various systems |
| .marketingStatusΣ | 0..* | MarketingStatus | Marketing status of the medicinal product, in contrast to marketing authorizaton |
| .pharmaceuticalProductΣ | 0..* | Reference(MedicinalProductPharmaceutical) | Pharmaceutical aspects of product |
| .packagedMedicinalProductΣ | 0..* | Reference(MedicinalProductPackaged) | Package representation for the product |
| .attachedDocumentΣ | 0..* | Reference(DocumentReference) | Supporting documentation, typically for regulatory submission |
| .masterFileΣ | 0..* | Reference(DocumentReference) | A master file for to the medicinal product (e.g. Pharmacovigilance System Master File) |
| .contactΣ | 0..* | Reference(Organization | PractitionerRole) | A product specific contact, person (in a role), or an organization |
| .clinicalTrialΣ | 0..* | Reference(ResearchStudy) | Clinical trials or studies that this product is involved in |
| .nameΣ | 1..* | BackboneElement | The product's name, including full name and possibly coded parts |
| .id | 0..1 | String | Unique id for inter-element referencing |
| .extension | 0..* | Extension | Additional content defined by implementations |
| .modifierExtension?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| .productNameΣ | 1..1 | string | The full product name |
| .namePartΣ | 0..* | BackboneElement | Coding words or phrases of the name |
| .id | 0..1 | String | Unique id for inter-element referencing |
| .extension | 0..* | Extension | Additional content defined by implementations |
| .modifierExtension?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| .partΣ | 1..1 | string | A fragment of a product name |
| .typeΣ | 1..1 | Coding | Idenifying type for this part of the name (e.g. strength part) |
| .countryLanguageΣ | 0..* | BackboneElement | Country where the name applies |
| .id | 0..1 | String | Unique id for inter-element referencing |
| .extension | 0..* | Extension | Additional content defined by implementations |
| .modifierExtension?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| .countryΣ | 1..1 | CodeableConcept | Country code for where this name applies |
| .jurisdictionΣ | 0..1 | CodeableConcept | Jurisdiction code for where this name applies |
| .languageΣ | 1..1 | CodeableConcept | Language code for this name |
| .crossReferenceΣ | 0..* | Identifier | Reference to another product, e.g. for linking authorised to investigational product |
| .manufacturingBusinessOperationΣ | 0..* | BackboneElement | An operation applied to the product, for manufacturing or adminsitrative purpose |
| .id | 0..1 | String | Unique id for inter-element referencing |
| .extension | 0..* | Extension | Additional content defined by implementations |
| .modifierExtension?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| .operationTypeΣ | 0..1 | CodeableConcept | The type of manufacturing operation |
| .authorisationReferenceNumberΣ | 0..1 | Identifier | Regulatory authorization reference number |
| .effectiveDateΣ | 0..1 | dateTime | Regulatory authorization date |
| .confidentialityIndicatorΣ | 0..1 | CodeableConcept | To indicate if this proces is commercially confidential |
| .manufacturerΣ | 0..* | Reference(Organization) | The manufacturer or establishment associated with the process |
| .regulatorΣ | 0..1 | Reference(Organization) | A regulator which oversees the operation |
| .specialDesignationΣ | 0..* | BackboneElement | Indicates if the medicinal product has an orphan designation for the treatment of a rare disease |
| .id | 0..1 | String | Unique id for inter-element referencing |
| .extension | 0..* | Extension | Additional content defined by implementations |
| .modifierExtension?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| .identifierΣ | 0..* | Identifier | Identifier for the designation, or procedure number |
| .typeΣ | 0..1 | CodeableConcept | The type of special designation, e.g. orphan drug, minor use |
| .intendedUseΣ | 0..1 | CodeableConcept | The intended use of the product, e.g. prevention, treatment |
| .indication[x]Σ | 0..1 | CodeableConcept | Reference(MedicinalProductIndication) | Condition for which the medicinal use applies |
| .statusΣ | 0..1 | CodeableConcept | For example granted, pending, expired or withdrawn |
| .dateΣ | 0..1 | dateTime | Date when the designation was granted |
| .speciesΣ | 0..1 | CodeableConcept | Animal species for which this applies |