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FHIR
Specification
(v3.3.0:
(v3.5.0:
R4
Ballot
2).
#2).
The
current
version
which
supercedes
this
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is
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.
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Biomedical
Research
and
Regulation
Work
Group
|
Maturity Level : 0 |
|
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). |
| Control | 1..1 |
| Type | DomainResource |
| Summary | true |
| MedicinalProduct.identifier | |
| Element Id | MedicinalProduct.identifier |
| Definition |
Business idenfifier for this product. Could be an MPID. |
| Note | This is a business identifer, not a resource identifier (see discussion ) |
| Control |
|
| Type | Identifier |
| Alternate Names | MPID |
| Summary | true |
| MedicinalProduct.type | |
| Element Id | MedicinalProduct.type |
| Definition |
Regulatory type, e.g. Investigational or Authorized. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.domain | |
| Element Id | MedicinalProduct.domain |
| Definition | If this medicine applies to human or veterinary uses. |
| Control | 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. |
| Control | 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. |
| Control | 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. |
| Control | 0..* |
| Type | string |
| Summary | true |
| MedicinalProduct.paediatricUseIndicator | |
| Element Id | MedicinalProduct.paediatricUseIndicator |
| Definition |
If authorised for use in children. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
|
|
|
| Element Id |
|
| Definition |
|
| Control |
|
| Type | CodeableConcept |
| Summary | true |
|
|
|
| Element Id |
|
| Definition |
|
| Control | 0..* |
| Type |
|
| Summary | true |
| MedicinalProduct.marketingAuthorization | |
| Element Id | MedicinalProduct.marketingAuthorization |
| Definition |
Product regulatory authorization. |
| Control | 0..1 |
| Type | Reference ( MedicinalProductAuthorization ) |
| Summary | true |
| MedicinalProduct.packagedMedicinalProduct | |
| Element Id | MedicinalProduct.packagedMedicinalProduct |
| Definition |
Package representation for the product. |
| Control | 0..* |
| Type | Reference ( MedicinalProductPackaged ) |
| Summary | true |
| MedicinalProduct.pharmaceuticalProduct | |
| Element Id | MedicinalProduct.pharmaceuticalProduct |
| Definition |
Pharmaceutical aspects of product. |
| Control | 0..* |
| Type | Reference ( MedicinalProductPharmaceutical ) |
| Summary | true |
|
|
|
| Element Id |
|
| Definition |
Clinical
|
| Control | 0..* |
| Type |
Reference
(
|
| Summary | true |
| MedicinalProduct.interaction | |
| Element Id | MedicinalProduct.interaction |
| Definition | Clinical interactions with other medications or substances. |
| Control | 0..* |
| Type | Reference ( MedicinalProductInteraction ) |
| Summary | true |
| MedicinalProduct.therapeuticIndication | |
| Element Id | MedicinalProduct.therapeuticIndication |
| Definition | Clinical reason for use. |
| Control | 0..* |
| Type | Reference ( MedicinalProductIndication ) |
| Summary | true |
| MedicinalProduct.undesirableEffect | |
| Element Id | MedicinalProduct.undesirableEffect |
| Definition | Potential clinical unwanted effects of use. |
| Control | 0..* |
| Type | Reference ( MedicinalProductUndesirableEffect ) |
| Summary | true |
| MedicinalProduct.attachedDocument | |
| Element Id | MedicinalProduct.attachedDocument |
| Definition |
Supporting documentation, typically for regulatory submission. |
| Control | 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). |
| Control | 0..* |
| Type | Reference ( DocumentReference ) |
| Summary | true |
| MedicinalProduct.contact | |
| Element Id | MedicinalProduct.contact |
| Definition | A product specific contact, person (in a role), or an organization. |
| Control | 0..* |
| Type | Reference ( Organization | PractitionerRole ) |
| Summary | true |
| MedicinalProduct.clinicalTrial | |
| Element Id | MedicinalProduct.clinicalTrial |
| Definition | Clinical trials or studies that this product is involved in. |
| Control | 0..* |
| Type | Reference ( ResearchStudy ) |
| Summary | true |
| MedicinalProduct.name | |
| Element Id | MedicinalProduct.name |
| Definition |
The product's name, including full name and possibly coded parts. |
| Control | 1..* |
| Summary | true |
|
|
|
| Element Id |
|
| Definition |
The full product name. |
| Control | 1..1 |
| Type | string |
| Summary | true |
| MedicinalProduct.name.namePart | |
| Element Id | MedicinalProduct.name.namePart |
| Definition |
Coding words or phrases of the name. |
| Control | 0..* |
| Summary | true |
| MedicinalProduct.name.namePart.part | |
| Element Id | MedicinalProduct.name.namePart.part |
| Definition |
A fragment of a product name. |
| Control | 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). |
| Control | 1..1 |
| Type | Coding |
| Summary | true |
| MedicinalProduct.name.countryLanguage | |
| Element Id | MedicinalProduct.name.countryLanguage |
| Definition |
Country where the name applies. |
| Control | 0..* |
| Summary | true |
| MedicinalProduct.name.countryLanguage.country | |
| Element Id | MedicinalProduct.name.countryLanguage.country |
| Definition |
Country code for where this name applies. |
| Control | 1..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.name.countryLanguage.jurisdiction | |
| Element Id | MedicinalProduct.name.countryLanguage.jurisdiction |
| Definition |
Jurisdiction code for where this name applies. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.name.countryLanguage.language | |
| Element Id | MedicinalProduct.name.countryLanguage.language |
| Definition |
Language code for this name. |
| Control | 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. |
| Control | 0..* |
| Type | Identifier |
| Summary | true |
| MedicinalProduct.manufacturingBusinessOperation | |
| Element Id | MedicinalProduct.manufacturingBusinessOperation |
| Definition |
An operation applied to the product, for manufacturing or adminsitrative purpose. |
| Control | 0..* |
| Summary | true |
| MedicinalProduct.manufacturingBusinessOperation.operationType | |
| Element Id | MedicinalProduct.manufacturingBusinessOperation.operationType |
| Definition |
The type of manufacturing operation. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber | |
| Element Id | MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber |
| Definition |
Regulatory authorization reference number. |
| Control | 0..1 |
| Type | Identifier |
| Summary | true |
| MedicinalProduct.manufacturingBusinessOperation.effectiveDate | |
| Element Id | MedicinalProduct.manufacturingBusinessOperation.effectiveDate |
| Definition |
Regulatory authorization date. |
| Control | 0..1 |
| Type | dateTime |
| Summary | true |
| MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator | |
| Element Id | MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator |
| Definition |
To indicate if this proces is commercially confidential. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.manufacturingBusinessOperation.manufacturer | |
| Element Id | MedicinalProduct.manufacturingBusinessOperation.manufacturer |
| Definition |
The manufacturer or establishment associated with the process. |
| Control | 0..* |
| Type | Reference ( Organization ) |
| Summary | true |
| MedicinalProduct.manufacturingBusinessOperation.regulator | |
| Element Id | MedicinalProduct.manufacturingBusinessOperation.regulator |
| Definition |
A regulator which oversees the operation. |
| Control | 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. |
| Control | 0..* |
| Summary | true |
| MedicinalProduct.specialDesignation.identifier | |
| Element Id | MedicinalProduct.specialDesignation.identifier |
| Definition | Identifier for the designation, or procedure number. |
| Note | This is a business identifer, not a resource identifier (see discussion ) |
| Control | 0..* |
| Type | Identifier |
| Summary | true |
| MedicinalProduct.specialDesignation.intendedUse | |
| Element Id | MedicinalProduct.specialDesignation.intendedUse |
| Definition | The intended use of the product, e.g. prevention, treatment. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.specialDesignation.indication | |
| Element Id | MedicinalProduct.specialDesignation.indication |
| Definition | Condition for which the medicinal use applies. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.specialDesignation.status | |
| Element Id | MedicinalProduct.specialDesignation.status |
| Definition | For example granted, pending, expired or withdrawn. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProduct.specialDesignation.date | |
| Element Id | MedicinalProduct.specialDesignation.date |
| Definition | Date when the designation was granted. |
| Control | 0..1 |
| Type | dateTime |
| Summary | true |
| MedicinalProduct.specialDesignation.species | |
| Element Id | MedicinalProduct.specialDesignation.species |
| Definition | Animal species for which this applies. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |