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Biomedical Research and Regulation Work Group | Maturity Level: 0 | Trial Use | Security Category: Anonymous | 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). |
Cardinality | 0..* |
Type | DomainResource |
Summary | true |
MedicinalProduct.identifier | |
Element Id | MedicinalProduct.identifier |
Definition | Business identifier for this product. Could be an MPID. |
Note | This is a business identifier, not a resource identifier (see discussion) |
Cardinality | 0..* |
Type | Identifier |
Alternate Names | MPID |
Summary | true |
MedicinalProduct.type | |
Element Id | MedicinalProduct.type |
Definition | Regulatory type, e.g. Investigational or Authorized. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProduct.domain | |
Element Id | MedicinalProduct.domain |
Definition | If this medicine applies to human or veterinary uses. |
Cardinality | 0..1 |
Type | Coding |
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. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProduct.legalStatusOfSupply | |
Element Id | MedicinalProduct.legalStatusOfSupply |
Definition | The legal status of supply of the medicinal product as classified by the regulator. |
Cardinality | 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. |
Cardinality | 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. |
Cardinality | 0..* |
Type | string |
Summary | true |
MedicinalProduct.paediatricUseIndicator | |
Element Id | MedicinalProduct.paediatricUseIndicator |
Definition | If authorised for use in children. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProduct.productClassification | |
Element Id | MedicinalProduct.productClassification |
Definition | Allows the product to be classified by various systems. |
Cardinality | 0..* |
Type | CodeableConcept |
Summary | true |
MedicinalProduct.marketingStatus | |
Element Id | MedicinalProduct.marketingStatus |
Definition | Marketing status of the medicinal product, in contrast to marketing authorizaton. |
Cardinality | 0..* |
Type | MarketingStatus |
Summary | true |
MedicinalProduct.pharmaceuticalProduct | |
Element Id | MedicinalProduct.pharmaceuticalProduct |
Definition | Pharmaceutical aspects of product. |
Cardinality | 0..* |
Type | Reference(MedicinalProductPharmaceutical) |
Summary | true |
MedicinalProduct.packagedMedicinalProduct | |
Element Id | MedicinalProduct.packagedMedicinalProduct |
Definition | Package representation for the product. |
Cardinality | 0..* |
Type | Reference(MedicinalProductPackaged) |
Summary | true |
MedicinalProduct.attachedDocument | |
Element Id | MedicinalProduct.attachedDocument |
Definition | Supporting documentation, typically for regulatory submission. |
Cardinality | 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). |
Cardinality | 0..* |
Type | Reference(DocumentReference) |
Summary | true |
MedicinalProduct.contact | |
Element Id | MedicinalProduct.contact |
Definition | A product specific contact, person (in a role), or an organization. |
Cardinality | 0..* |
Type | Reference(Organization | PractitionerRole) |
Summary | true |
MedicinalProduct.clinicalTrial | |
Element Id | MedicinalProduct.clinicalTrial |
Definition | Clinical trials or studies that this product is involved in. |
Cardinality | 0..* |
Type | Reference(ResearchStudy) |
Summary | true |
MedicinalProduct.name | |
Element Id | MedicinalProduct.name |
Definition | The product's name, including full name and possibly coded parts. |
Cardinality | 1..* |
Summary | true |
MedicinalProduct.name.productName | |
Element Id | MedicinalProduct.name.productName |
Definition | The full product name. |
Cardinality | 1..1 |
Type | string |
Summary | true |
MedicinalProduct.name.namePart | |
Element Id | MedicinalProduct.name.namePart |
Definition | Coding words or phrases of the name. |
Cardinality | 0..* |
Summary | true |
MedicinalProduct.name.namePart.part | |
Element Id | MedicinalProduct.name.namePart.part |
Definition | A fragment of a product name. |
Cardinality | 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). |
Cardinality | 1..1 |
Type | Coding |
Summary | true |
MedicinalProduct.name.countryLanguage | |
Element Id | MedicinalProduct.name.countryLanguage |
Definition | Country where the name applies. |
Cardinality | 0..* |
Summary | true |
MedicinalProduct.name.countryLanguage.country | |
Element Id | MedicinalProduct.name.countryLanguage.country |
Definition | Country code for where this name applies. |
Cardinality | 1..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProduct.name.countryLanguage.jurisdiction | |
Element Id | MedicinalProduct.name.countryLanguage.jurisdiction |
Definition | Jurisdiction code for where this name applies. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProduct.name.countryLanguage.language | |
Element Id | MedicinalProduct.name.countryLanguage.language |
Definition | Language code for this name. |
Cardinality | 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. |
Cardinality | 0..* |
Type | Identifier |
Summary | true |
MedicinalProduct.manufacturingBusinessOperation | |
Element Id | MedicinalProduct.manufacturingBusinessOperation |
Definition | An operation applied to the product, for manufacturing or adminsitrative purpose. |
Cardinality | 0..* |
Summary | true |
MedicinalProduct.manufacturingBusinessOperation.operationType | |
Element Id | MedicinalProduct.manufacturingBusinessOperation.operationType |
Definition | The type of manufacturing operation. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber | |
Element Id | MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber |
Definition | Regulatory authorization reference number. |
Cardinality | 0..1 |
Type | Identifier |
Summary | true |
MedicinalProduct.manufacturingBusinessOperation.effectiveDate | |
Element Id | MedicinalProduct.manufacturingBusinessOperation.effectiveDate |
Definition | Regulatory authorization date. |
Cardinality | 0..1 |
Type | dateTime |
Summary | true |
MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator | |
Element Id | MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator |
Definition | To indicate if this proces is commercially confidential. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProduct.manufacturingBusinessOperation.manufacturer | |
Element Id | MedicinalProduct.manufacturingBusinessOperation.manufacturer |
Definition | The manufacturer or establishment associated with the process. |
Cardinality | 0..* |
Type | Reference(Organization) |
Summary | true |
MedicinalProduct.manufacturingBusinessOperation.regulator | |
Element Id | MedicinalProduct.manufacturingBusinessOperation.regulator |
Definition | A regulator which oversees the operation. |
Cardinality | 0..1 |
Type | Reference(Organization) |
Summary | true |
MedicinalProduct.specialDesignation | |
Element Id | MedicinalProduct.specialDesignation |
Definition | Indicates if the medicinal product has an orphan designation for the treatment of a rare disease. |
Cardinality | 0..* |
Summary | true |
MedicinalProduct.specialDesignation.identifier | |
Element Id | MedicinalProduct.specialDesignation.identifier |
Definition | Identifier for the designation, or procedure number. |
Note | This is a business identifier, not a resource identifier (see discussion) |
Cardinality | 0..* |
Type | Identifier |
Summary | true |
MedicinalProduct.specialDesignation.type | |
Element Id | MedicinalProduct.specialDesignation.type |
Definition | The type of special designation, e.g. orphan drug, minor use. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProduct.specialDesignation.intendedUse | |
Element Id | MedicinalProduct.specialDesignation.intendedUse |
Definition | The intended use of the product, e.g. prevention, treatment. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProduct.specialDesignation.indication[x] | |
Element Id | MedicinalProduct.specialDesignation.indication[x] |
Definition | Condition for which the medicinal use applies. |
Cardinality | 0..1 |
Type | CodeableConcept|Reference(MedicinalProductIndication) |
[x] Note | See Choice of Data Types for further information about how to use [x] |
Summary | true |
MedicinalProduct.specialDesignation.status | |
Element Id | MedicinalProduct.specialDesignation.status |
Definition | For example granted, pending, expired or withdrawn. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProduct.specialDesignation.date | |
Element Id | MedicinalProduct.specialDesignation.date |
Definition | Date when the designation was granted. |
Cardinality | 0..1 |
Type | dateTime |
Summary | true |
MedicinalProduct.specialDesignation.species | |
Element Id | MedicinalProduct.specialDesignation.species |
Definition | Animal species for which this applies. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |