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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 |
A pharmaceutical product described in terms of its composition and dose form.
This resource is still undergoing development and review by the appropriate Workgroups. At this time, is considered only as a draft resource not suitable for production implementation
Qualitative and quantitative composition of a Medicinal Product in the dose form approved for administration in line with the regulated product information
Note that in many instances, the pharmaceutical product is equal to the manufactured item. However, there are instances where the manufactured item must undergo a transformation before being administered to the patient (as the pharmaceutical product) and the two are not equal.
This resource is referenced by MedicinalProduct
Structure
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
MedicinalProductPharmaceutical | ΣTU | DomainResource | A pharmaceutical product described in terms of its composition and dose form Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension | |
identifier | Σ | 0..* | Identifier | An identifier for the pharmaceutical medicinal product |
administrableDoseForm | Σ | 1..1 | CodeableConcept | The administrable dose form, after necessary reconstitution |
unitOfPresentation | Σ | 0..1 | CodeableConcept | Todo |
ingredient | Σ | 0..* | Reference(MedicinalProductIngredient) | Ingredient |
device | Σ | 0..* | Reference(DeviceDefinition) | Accompanying device |
characteristics | Σ | 0..* | BackboneElement | Characteristics e.g. a products onset of action |
code | Σ | 1..1 | CodeableConcept | A coded characteristic |
status | Σ | 0..1 | CodeableConcept | The status of characteristic e.g. assigned or pending |
routeOfAdministration | Σ | 1..* | BackboneElement | The path by which the pharmaceutical product is taken into or makes contact with the body |
code | Σ | 1..1 | CodeableConcept | Coded expression for the route |
firstDose | Σ | 0..1 | Quantity | The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement |
maxSingleDose | Σ | 0..1 | Quantity | The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement |
maxDosePerDay | Σ | 0..1 | Quantity | The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation |
maxDosePerTreatmentPeriod | Σ | 0..1 | Ratio | The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation |
maxTreatmentPeriod | Σ | 0..1 | Duration | The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation |
targetSpecies | Σ | 0..* | BackboneElement | A species for which this route applies |
code | Σ | 1..1 | CodeableConcept | Coded expression for the species |
withdrawalPeriod | Σ | 0..* | BackboneElement | A species specific time during which consumption of animal product is not appropriate |
tissue | Σ | 1..1 | CodeableConcept | Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk |
value | Σ | 1..1 | Quantity | A value for the time |
supportingInformation | Σ | 0..1 | string | Extra information about the withdrawal period |
Documentation for this format |
UML Diagram (Legend)
XML Template
<MedicinalProductPharmaceutical xmlns="http://hl7.org/fhir"> <!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <identifier><!-- 0..* Identifier An identifier for the pharmaceutical medicinal product --></identifier> <administrableDoseForm><!-- 1..1 CodeableConcept The administrable dose form, after necessary reconstitution --></administrableDoseForm> <unitOfPresentation><!-- 0..1 CodeableConcept Todo --></unitOfPresentation> <ingredient><!-- 0..* Reference(MedicinalProductIngredient) Ingredient --></ingredient> <device><!-- 0..* Reference(DeviceDefinition) Accompanying device --></device> <characteristics> <!-- 0..* Characteristics e.g. a products onset of action --> <code><!-- 1..1 CodeableConcept A coded characteristic --></code> <status><!-- 0..1 CodeableConcept The status of characteristic e.g. assigned or pending --></status> </characteristics> <routeOfAdministration> <!-- 1..* The path by which the pharmaceutical product is taken into or makes contact with the body --> <code><!-- 1..1 CodeableConcept Coded expression for the route --></code> <firstDose><!-- 0..1 Quantity The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement --></firstDose> <maxSingleDose><!-- 0..1 Quantity The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement --></maxSingleDose> <maxDosePerDay><!-- 0..1 Quantity The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation --></maxDosePerDay> <maxDosePerTreatmentPeriod><!-- 0..1 Ratio The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation --></maxDosePerTreatmentPeriod> <maxTreatmentPeriod><!-- 0..1 Duration The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation --></maxTreatmentPeriod> <targetSpecies> <!-- 0..* A species for which this route applies --> <code><!-- 1..1 CodeableConcept Coded expression for the species --></code> <withdrawalPeriod> <!-- 0..* A species specific time during which consumption of animal product is not appropriate --> <tissue><!-- 1..1 CodeableConcept Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk --></tissue> <value><!-- 1..1 Quantity A value for the time --></value> <supportingInformation value="[string]"/><!-- 0..1 Extra information about the withdrawal period --> </withdrawalPeriod> </targetSpecies> </routeOfAdministration> </MedicinalProductPharmaceutical>
JSON Template
{ "resourceType" : "MedicinalProductPharmaceutical", // from Resource: id, meta, implicitRules, and language // from DomainResource: text, contained, extension, and modifierExtension "identifier" : [{ Identifier }], // An identifier for the pharmaceutical medicinal product "administrableDoseForm" : { CodeableConcept }, // R! The administrable dose form, after necessary reconstitution "unitOfPresentation" : { CodeableConcept }, // Todo "ingredient" : [{ Reference(MedicinalProductIngredient) }], // Ingredient "device" : [{ Reference(DeviceDefinition) }], // Accompanying device "characteristics" : [{ // Characteristics e.g. a products onset of action "code" : { CodeableConcept }, // R! A coded characteristic "status" : { CodeableConcept } // The status of characteristic e.g. assigned or pending }], "routeOfAdministration" : [{ // R! The path by which the pharmaceutical product is taken into or makes contact with the body "code" : { CodeableConcept }, // R! Coded expression for the route "firstDose" : { Quantity }, // The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement "maxSingleDose" : { Quantity }, // The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement "maxDosePerDay" : { Quantity }, // The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation "maxDosePerTreatmentPeriod" : { Ratio }, // The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation "maxTreatmentPeriod" : { Duration }, // The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation "targetSpecies" : [{ // A species for which this route applies "code" : { CodeableConcept }, // R! Coded expression for the species "withdrawalPeriod" : [{ // A species specific time during which consumption of animal product is not appropriate "tissue" : { CodeableConcept }, // R! Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk "value" : { Quantity }, // R! A value for the time "supportingInformation" : "<string>" // Extra information about the withdrawal period }] }] }] }
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> . [ a fhir:MedicinalProductPharmaceutical; fhir:nodeRole fhir:treeRoot; # if this is the parser root # from Resource: .id, .meta, .implicitRules, and .language # from DomainResource: .text, .contained, .extension, and .modifierExtension fhir:MedicinalProductPharmaceutical.identifier [ Identifier ], ... ; # 0..* An identifier for the pharmaceutical medicinal product fhir:MedicinalProductPharmaceutical.administrableDoseForm [ CodeableConcept ]; # 1..1 The administrable dose form, after necessary reconstitution fhir:MedicinalProductPharmaceutical.unitOfPresentation [ CodeableConcept ]; # 0..1 Todo fhir:MedicinalProductPharmaceutical.ingredient [ Reference(MedicinalProductIngredient) ], ... ; # 0..* Ingredient fhir:MedicinalProductPharmaceutical.device [ Reference(DeviceDefinition) ], ... ; # 0..* Accompanying device fhir:MedicinalProductPharmaceutical.characteristics [ # 0..* Characteristics e.g. a products onset of action fhir:MedicinalProductPharmaceutical.characteristics.code [ CodeableConcept ]; # 1..1 A coded characteristic fhir:MedicinalProductPharmaceutical.characteristics.status [ CodeableConcept ]; # 0..1 The status of characteristic e.g. assigned or pending ], ...; fhir:MedicinalProductPharmaceutical.routeOfAdministration [ # 1..* The path by which the pharmaceutical product is taken into or makes contact with the body fhir:MedicinalProductPharmaceutical.routeOfAdministration.code [ CodeableConcept ]; # 1..1 Coded expression for the route fhir:MedicinalProductPharmaceutical.routeOfAdministration.firstDose [ Quantity ]; # 0..1 The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement fhir:MedicinalProductPharmaceutical.routeOfAdministration.maxSingleDose [ Quantity ]; # 0..1 The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement fhir:MedicinalProductPharmaceutical.routeOfAdministration.maxDosePerDay [ Quantity ]; # 0..1 The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation fhir:MedicinalProductPharmaceutical.routeOfAdministration.maxDosePerTreatmentPeriod [ Ratio ]; # 0..1 The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation fhir:MedicinalProductPharmaceutical.routeOfAdministration.maxTreatmentPeriod [ Duration ]; # 0..1 The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation fhir:MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies [ # 0..* A species for which this route applies fhir:MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.code [ CodeableConcept ]; # 1..1 Coded expression for the species fhir:MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod [ # 0..* A species specific time during which consumption of animal product is not appropriate fhir:MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue [ CodeableConcept ]; # 1..1 Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk fhir:MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod.value [ Quantity ]; # 1..1 A value for the time fhir:MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod.supportingInformation [ string ]; # 0..1 Extra information about the withdrawal period ], ...; ], ...; ], ...; ]
Structure
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
MedicinalProductPharmaceutical | ΣTU | DomainResource | A pharmaceutical product described in terms of its composition and dose form Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension | |
identifier | Σ | 0..* | Identifier | An identifier for the pharmaceutical medicinal product |
administrableDoseForm | Σ | 1..1 | CodeableConcept | The administrable dose form, after necessary reconstitution |
unitOfPresentation | Σ | 0..1 | CodeableConcept | Todo |
ingredient | Σ | 0..* | Reference(MedicinalProductIngredient) | Ingredient |
device | Σ | 0..* | Reference(DeviceDefinition) | Accompanying device |
characteristics | Σ | 0..* | BackboneElement | Characteristics e.g. a products onset of action |
code | Σ | 1..1 | CodeableConcept | A coded characteristic |
status | Σ | 0..1 | CodeableConcept | The status of characteristic e.g. assigned or pending |
routeOfAdministration | Σ | 1..* | BackboneElement | The path by which the pharmaceutical product is taken into or makes contact with the body |
code | Σ | 1..1 | CodeableConcept | Coded expression for the route |
firstDose | Σ | 0..1 | Quantity | The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement |
maxSingleDose | Σ | 0..1 | Quantity | The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement |
maxDosePerDay | Σ | 0..1 | Quantity | The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation |
maxDosePerTreatmentPeriod | Σ | 0..1 | Ratio | The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation |
maxTreatmentPeriod | Σ | 0..1 | Duration | The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation |
targetSpecies | Σ | 0..* | BackboneElement | A species for which this route applies |
code | Σ | 1..1 | CodeableConcept | Coded expression for the species |
withdrawalPeriod | Σ | 0..* | BackboneElement | A species specific time during which consumption of animal product is not appropriate |
tissue | Σ | 1..1 | CodeableConcept | Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk |
value | Σ | 1..1 | Quantity | A value for the time |
supportingInformation | Σ | 0..1 | string | Extra information about the withdrawal period |
Documentation for this format |
XML Template
<MedicinalProductPharmaceutical xmlns="http://hl7.org/fhir"> <!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <identifier><!-- 0..* Identifier An identifier for the pharmaceutical medicinal product --></identifier> <administrableDoseForm><!-- 1..1 CodeableConcept The administrable dose form, after necessary reconstitution --></administrableDoseForm> <unitOfPresentation><!-- 0..1 CodeableConcept Todo --></unitOfPresentation> <ingredient><!-- 0..* Reference(MedicinalProductIngredient) Ingredient --></ingredient> <device><!-- 0..* Reference(DeviceDefinition) Accompanying device --></device> <characteristics> <!-- 0..* Characteristics e.g. a products onset of action --> <code><!-- 1..1 CodeableConcept A coded characteristic --></code> <status><!-- 0..1 CodeableConcept The status of characteristic e.g. assigned or pending --></status> </characteristics> <routeOfAdministration> <!-- 1..* The path by which the pharmaceutical product is taken into or makes contact with the body --> <code><!-- 1..1 CodeableConcept Coded expression for the route --></code> <firstDose><!-- 0..1 Quantity The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement --></firstDose> <maxSingleDose><!-- 0..1 Quantity The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement --></maxSingleDose> <maxDosePerDay><!-- 0..1 Quantity The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation --></maxDosePerDay> <maxDosePerTreatmentPeriod><!-- 0..1 Ratio The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation --></maxDosePerTreatmentPeriod> <maxTreatmentPeriod><!-- 0..1 Duration The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation --></maxTreatmentPeriod> <targetSpecies> <!-- 0..* A species for which this route applies --> <code><!-- 1..1 CodeableConcept Coded expression for the species --></code> <withdrawalPeriod> <!-- 0..* A species specific time during which consumption of animal product is not appropriate --> <tissue><!-- 1..1 CodeableConcept Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk --></tissue> <value><!-- 1..1 Quantity A value for the time --></value> <supportingInformation value="[string]"/><!-- 0..1 Extra information about the withdrawal period --> </withdrawalPeriod> </targetSpecies> </routeOfAdministration> </MedicinalProductPharmaceutical>
JSON Template
{ "resourceType" : "MedicinalProductPharmaceutical", // from Resource: id, meta, implicitRules, and language // from DomainResource: text, contained, extension, and modifierExtension "identifier" : [{ Identifier }], // An identifier for the pharmaceutical medicinal product "administrableDoseForm" : { CodeableConcept }, // R! The administrable dose form, after necessary reconstitution "unitOfPresentation" : { CodeableConcept }, // Todo "ingredient" : [{ Reference(MedicinalProductIngredient) }], // Ingredient "device" : [{ Reference(DeviceDefinition) }], // Accompanying device "characteristics" : [{ // Characteristics e.g. a products onset of action "code" : { CodeableConcept }, // R! A coded characteristic "status" : { CodeableConcept } // The status of characteristic e.g. assigned or pending }], "routeOfAdministration" : [{ // R! The path by which the pharmaceutical product is taken into or makes contact with the body "code" : { CodeableConcept }, // R! Coded expression for the route "firstDose" : { Quantity }, // The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement "maxSingleDose" : { Quantity }, // The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement "maxDosePerDay" : { Quantity }, // The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation "maxDosePerTreatmentPeriod" : { Ratio }, // The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation "maxTreatmentPeriod" : { Duration }, // The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation "targetSpecies" : [{ // A species for which this route applies "code" : { CodeableConcept }, // R! Coded expression for the species "withdrawalPeriod" : [{ // A species specific time during which consumption of animal product is not appropriate "tissue" : { CodeableConcept }, // R! Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk "value" : { Quantity }, // R! A value for the time "supportingInformation" : "<string>" // Extra information about the withdrawal period }] }] }] }
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> . [ a fhir:MedicinalProductPharmaceutical; fhir:nodeRole fhir:treeRoot; # if this is the parser root # from Resource: .id, .meta, .implicitRules, and .language # from DomainResource: .text, .contained, .extension, and .modifierExtension fhir:MedicinalProductPharmaceutical.identifier [ Identifier ], ... ; # 0..* An identifier for the pharmaceutical medicinal product fhir:MedicinalProductPharmaceutical.administrableDoseForm [ CodeableConcept ]; # 1..1 The administrable dose form, after necessary reconstitution fhir:MedicinalProductPharmaceutical.unitOfPresentation [ CodeableConcept ]; # 0..1 Todo fhir:MedicinalProductPharmaceutical.ingredient [ Reference(MedicinalProductIngredient) ], ... ; # 0..* Ingredient fhir:MedicinalProductPharmaceutical.device [ Reference(DeviceDefinition) ], ... ; # 0..* Accompanying device fhir:MedicinalProductPharmaceutical.characteristics [ # 0..* Characteristics e.g. a products onset of action fhir:MedicinalProductPharmaceutical.characteristics.code [ CodeableConcept ]; # 1..1 A coded characteristic fhir:MedicinalProductPharmaceutical.characteristics.status [ CodeableConcept ]; # 0..1 The status of characteristic e.g. assigned or pending ], ...; fhir:MedicinalProductPharmaceutical.routeOfAdministration [ # 1..* The path by which the pharmaceutical product is taken into or makes contact with the body fhir:MedicinalProductPharmaceutical.routeOfAdministration.code [ CodeableConcept ]; # 1..1 Coded expression for the route fhir:MedicinalProductPharmaceutical.routeOfAdministration.firstDose [ Quantity ]; # 0..1 The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement fhir:MedicinalProductPharmaceutical.routeOfAdministration.maxSingleDose [ Quantity ]; # 0..1 The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement fhir:MedicinalProductPharmaceutical.routeOfAdministration.maxDosePerDay [ Quantity ]; # 0..1 The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation fhir:MedicinalProductPharmaceutical.routeOfAdministration.maxDosePerTreatmentPeriod [ Ratio ]; # 0..1 The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation fhir:MedicinalProductPharmaceutical.routeOfAdministration.maxTreatmentPeriod [ Duration ]; # 0..1 The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation fhir:MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies [ # 0..* A species for which this route applies fhir:MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.code [ CodeableConcept ]; # 1..1 Coded expression for the species fhir:MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod [ # 0..* A species specific time during which consumption of animal product is not appropriate fhir:MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue [ CodeableConcept ]; # 1..1 Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk fhir:MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod.value [ Quantity ]; # 1..1 A value for the time fhir:MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod.supportingInformation [ string ]; # 0..1 Extra information about the withdrawal period ], ...; ], ...; ], ...; ]
See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions & the dependency analysis
Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.
Name | Type | Description | Expression | In Common |
identifier | token | An identifier for the pharmaceutical medicinal product | MedicinalProductPharmaceutical.identifier | |
route | token | Coded expression for the route | MedicinalProductPharmaceutical.routeOfAdministration.code | |
target-species | token | Coded expression for the species | MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.code |