Generated Narrative: StructureDefinition ext-R4B-MedicinalProductDefinition Name Flags Card. Type Description & Constraints <a href="StructureDefinition-ext-R4B-MedicinalProductDefinition-definitions.html#Extension" title="A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).">Extension 0..* Extension(4.0.1) Detailed definition of a medicinal product #xD; Slices for extension 1..* Extension Extension Slice: Unordered, Closed by value:url #xD; extension:type 0..1 Extension Regulatory type, e.g. Investigational or Authorized #xD; url 1..1 uri "type" #xD; value[x] 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized Binding: R4B_medicinal_product_type_for_R4 (0.0.1-snapshot-2) (example): Overall defining type of this medicinal product. #xD; extension:domain 0..1 Extension If this medicine applies to human or veterinary uses #xD; url 1..1 uri "domain" #xD; value[x] 0..1 CodeableConcept If this medicine applies to human or veterinary uses Binding: R4B_medicinal_product_domain_for_R4 (0.0.1-snapshot-2) (example): Applicable domain for this product (e.g. human, veterinary). #xD; extension:version 0..1 Extension A business identifier relating to a specific version of the product #xD; url 1..1 uri "version" #xD; value[x] 0..1 string A business identifier relating to a specific version of the product #xD; extension:status 0..1 Extension The status within the lifecycle of this product record #xD; url 1..1 uri "status" #xD; value[x] 0..1 CodeableConcept The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact. #xD; extension:statusDate 0..1 Extension The date at which the given status became applicable #xD; url 1..1 uri "statusDate" #xD; value[x] 0..1 dateTime The date at which the given status became applicable #xD; extension:description 0..1 Extension General description of this product #xD; url 1..1 uri "description" #xD; value[x] 0..1 markdown General description of this product #xD; <a href="StructureDefinition-ext-R4B-MedicinalProductDefinition-definitions.html#Extension.extension:combinedPharmaceuticalDoseForm" title="Slice combinedPharmaceuticalDoseForm: The dose form for a single part product, or combined form of a multiple part product. This is one concept that describes all the components. It does not represent the form with components physically mixed, if that might be necessary, for which see (AdministrableProductDefinition.administrableDoseForm).">extension:combinedPharmaceuticalDoseForm 0..1 Extension The dose form for a single part product, or combined form of a multiple part product #xD; url 1..1 uri "combinedPharmaceuticalDoseForm" #xD; <a href="StructureDefinition-ext-R4B-MedicinalProductDefinition-definitions.html#Extension.extension:combinedPharmaceuticalDoseForm.value[x]" title="The dose form for a single part product, or combined form of a multiple part product. This is one concept that describes all the components. It does not represent the form with components physically mixed, if that might be necessary, for which see (AdministrableProductDefinition.administrableDoseForm).">value[x] 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product Binding: R4B_combined_dose_form_for_R4 (0.0.1-snapshot-2) (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing #xD; <a href="StructureDefinition-ext-R4B-MedicinalProductDefinition-definitions.html#Extension.extension:route" title="Slice route: The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route. See also AdministrableProductDefinition resource. MedicinalProductDefinition.route is the same concept as AdministrableProductDefinition.routeOfAdministration.code, and they cannot be used together.">extension:route 0..* Extension The path by which the product is taken into or makes contact with the body #xD; url 1..1 uri "route" #xD; <a href="StructureDefinition-ext-R4B-MedicinalProductDefinition-definitions.html#Extension.extension:route.value[x]" title="The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route. See also AdministrableProductDefinition resource. MedicinalProductDefinition.route is the same concept as AdministrableProductDefinition.routeOfAdministration.code, and they cannot be used together.">value[x] 0..1 CodeableConcept The path by which the product is taken into or makes contact with the body Binding: R4B_route_codes_for_R4 (0.0.1-snapshot-2) (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body. #xD; <a href="StructureDefinition-ext-R4B-MedicinalProductDefinition-definitions.html#Extension.extension:indication" title="Slice indication: Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseDefinition resource. An indication is a medical situation for which using the product is appropriate.">extension:indication 0..1 Extension Description of indication(s) for this product, used when structured indications are not required #xD; url 1..1 uri "indication" #xD; <a href="StructureDefinition-ext-R4B-MedicinalProductDefinition-definitions.html#Extension.extension:indication.value[x]" title="Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseDefinition resource. An indication is a medical situation for which using the product is appropriate.">value[x] 0..1 markdown Description of indication(s) for this product, used when structured indications are not required #xD; extension:legalStatusOfSupply 0..1 Extension The legal status of supply of the medicinal product as classified by the regulator #xD; url 1..1 uri "legalStatusOfSupply" #xD; value[x] 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator Binding: R4B_legal_status_of_supply_for_R4 (0.0.1-snapshot-2) (example): The prescription supply types appropriate to a medicinal product #xD; extension:additionalMonitoringIndicator 0..1 Extension Whether the Medicinal Product is subject to additional monitoring for regulatory reasons #xD; url 1..1 uri "additionalMonitoringIndicator" #xD; value[x] 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: R4B_medicinal_product_additional_monitoring_for_R4 (0.0.1-snapshot-2) (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring). #xD; extension:specialMeasures 0..* Extension Whether the Medicinal Product is subject to special measures for regulatory reasons #xD; url 1..1 uri "specialMeasures" #xD; value[x] 0..1 CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: R4B_medicinal_product_special_measures_for_R4 (0.0.1-snapshot-2) (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorisation studies. #xD; extension:pediatricUseIndicator 0..1 Extension If authorised for use in children #xD; url 1..1 uri "pediatricUseIndicator" #xD; value[x] 0..1 CodeableConcept If authorised for use in children Binding: R4B_medicinal_product_pediatric_use_for_R4 (0.0.1-snapshot-2) (example): Suitability for age groups, in particular children. #xD; extension:classification 0..* Extension Allows the product to be classified by various systems #xD; url 1..1 uri "classification" #xD; value[x] 0..1 CodeableConcept Allows the product to be classified by various systems Binding: AccountStatus (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. #xD; extension:marketingStatus 0..* Extension Marketing status of the medicinal product, in contrast to marketing authorization #xD; Slices for extension 1..* Extension Extension Slice: Unordered, Closed by value:url #xD; extension:country 0..1 Extension The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements #xD; url 1..1 uri "country" #xD; value[x] 0..1 CodeableConcept The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements #xD; extension:jurisdiction 0..1 Extension Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified #xD; url 1..1 uri "jurisdiction" #xD; value[x] 0..1 CodeableConcept Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified #xD; extension:status 1..1 Extension This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples #xD; url 1..1 uri "status" #xD; value[x] 0..1 CodeableConcept This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples #xD; extension:dateRange 0..1 Extension The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain #xD; url 1..1 uri "dateRange" #xD; value[x] 0..1 Period The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain #xD; extension:restoreDate 0..1 Extension The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain #xD; url 1..1 uri "restoreDate" #xD; value[x] 0..1 dateTime The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain #xD; extension:_datatype 0..1 (Complex) Data type name for MedicinalProductDefinition.marketingStatus from FHIR R4B URL: http://hl7.org/fhir/StructureDefinition/_datatype #xD; value[x] 1..1 string Value of extension Fixed Value: MarketingStatus #xD; url 1..1 uri "marketingStatus" #xD; extension:packagedMedicinalProduct 0..* Extension Package type for the product #xD; url 1..1 uri "packagedMedicinalProduct" #xD; value[x] 0..1 CodeableConcept Package type for the product Binding: R4B_medicinal_product_package_type_for_R4 (0.0.1-snapshot-2) (example): Types of medicinal product packs #xD; <a href="StructureDefinition-ext-R4B-MedicinalProductDefinition-definitions.html#Extension.extension:ingredient" title="Slice ingredient: The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes.">extension:ingredient 0..* Extension The ingredients of this medicinal product - when not detailed in other resources #xD; url 1..1 uri "ingredient" #xD; <a href="StructureDefinition-ext-R4B-MedicinalProductDefinition-definitions.html#Extension.extension:ingredient.value[x]" title="The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes.">value[x] 0..1 CodeableConcept The ingredients of this medicinal product - when not detailed in other resources Binding: AccountStatus (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. #xD; extension:impurity 0..* Extension Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Closed by value:url #xD; extension:concept 0..1 Extension Reference to a concept (by class) #xD; url 1..1 uri "concept" #xD; value[x] 0..1 CodeableConcept Reference to a concept (by class) #xD; extension:reference 0..1 Extension Reference to a resource (by instance) #xD; url 1..1 uri "reference" #xD; value[x] 0..1 Reference() Reference to a resource (by instance) #xD; extension:_datatype 0..1 (Complex) Data type name for MedicinalProductDefinition.impurity from FHIR R4B URL: http://hl7.org/fhir/StructureDefinition/_datatype #xD; value[x] 1..1 string Value of extension Fixed Value: CodeableReference #xD; url 1..1 uri "impurity" #xD; extension:attachedDocument 0..* Extension Additional documentation about the medicinal product #xD; url 1..1 uri "attachedDocument" #xD; value[x] 0..1 Reference() Additional documentation about the medicinal product #xD; <a href="StructureDefinition-ext-R4B-MedicinalProductDefinition-definitions.html#Extension.extension:masterFile" title="Slice masterFile: A master file for the medicinal product (e.g. Pharmacovigilance System Master File). Drug master files (DMFs) are documents submitted to regulatory agencies to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of drug products.">extension:masterFile 0..* Extension A master file for the medicinal product (e.g. Pharmacovigilance System Master File) #xD; url 1..1 uri "masterFile" #xD; <a href="StructureDefinition-ext-R4B-MedicinalProductDefinition-definitions.html#Extension.extension:masterFile.value[x]" title="A master file for the medicinal product (e.g. Pharmacovigilance System Master File). Drug master files (DMFs) are documents submitted to regulatory agencies to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of drug products.">value[x] 0..1 Reference() A master file for the medicinal product (e.g. Pharmacovigilance System Master File) #xD; extension:contact 0..* Extension A product specific contact, person (in a role), or an organization #xD; Slices for extension 1..* Extension Extension Slice: Unordered, Closed by value:url #xD; extension:type 0..1 Extension Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information #xD; url 1..1 uri "type" #xD; value[x] 0..1 CodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information Binding: R4B_medicinal_product_contact_type_for_R4 (0.0.1-snapshot-2) (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. #xD; extension:contact 1..1 Extension A product specific contact, person (in a role), or an organization #xD; url 1..1 uri "contact" #xD; value[x] 0..1 Reference() A product specific contact, person (in a role), or an organization #xD; url 1..1 uri "contact" #xD; extension:clinicalTrial 0..* Extension Clinical trials or studies that this product is involved in #xD; url 1..1 uri "clinicalTrial" #xD; value[x] 0..1 Reference() Clinical trials or studies that this product is involved in #xD; extension:name 1..* Extension The product's name, including full name and possibly coded parts #xD; Slices for extension 1..* Extension Extension Slice: Unordered, Closed by value:url #xD; extension:productName 1..1 Extension The full product name #xD; url 1..1 uri "productName" #xD; value[x] 0..1 string The full product name #xD; extension:type 0..1 Extension Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary #xD; url 1..1 uri "type" #xD; value[x] 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: R4B_medicinal_product_name_type_for_R4 (0.0.1-snapshot-2) (example): Type of a name for a Medicinal Product. #xD; extension:namePart 0..* Extension Coding words or phrases of the name #xD; Slices for extension 2..* Extension Extension Slice: Unordered, Closed by value:url #xD; extension:part 1..1 Extension A fragment of a product name #xD; url 1..1 uri "part" #xD; value[x] 0..1 string A fragment of a product name #xD; extension:type 1..1 Extension Identifying type for this part of the name (e.g. strength part) #xD; url 1..1 uri "type" #xD; value[x] 0..1 CodeableConcept Identifying type for this part of the name (e.g. strength part) Binding: R4B_medicinal_product_name_part_type_for_R4 (0.0.1-snapshot-2) (example): Type of part of a name for a Medicinal Product. #xD; url 1..1 uri "namePart" #xD; extension:countryLanguage 0..* Extension Country and jurisdiction where the name applies #xD; Slices for extension 2..* Extension Extension Slice: Unordered, Closed by value:url #xD; extension:country 1..1 Extension Country code for where this name applies #xD; url 1..1 uri "country" #xD; value[x] 0..1 CodeableConcept Country code for where this name applies Binding: R4B_country_for_R4 (0.0.1-snapshot-2) (example): Jurisdiction codes #xD; extension:jurisdiction 0..1 Extension Jurisdiction code for where this name applies #xD; url 1..1 uri "jurisdiction" #xD; value[x] 0..1 CodeableConcept Jurisdiction code for where this name applies Binding: R4B_jurisdiction_for_R4 (0.0.1-snapshot-2) (example): Jurisdiction codes #xD; extension:language 1..1 Extension Language code for this name #xD; url 1..1 uri "language" #xD; value[x] 0..1 CodeableConcept Language code for this name Binding: AllLanguages (required) #xD; url 1..1 uri "countryLanguage" #xD; url 1..1 uri "name" #xD; extension:crossReference 0..* Extension Reference to another product, e.g. for linking authorised to investigational product #xD; Slices for extension 1..* Extension Extension Slice: Unordered, Closed by value:url #xD; extension:product 1..1 Extension Reference to another product, e.g. for linking authorised to investigational product #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Closed by value:url #xD; extension:concept 0..1 Extension Reference to a concept (by class) #xD; url 1..1 uri "concept" #xD; value[x] 0..1 CodeableConcept Reference to a concept (by class) #xD; extension:reference 0..1 Extension Reference to a resource (by instance) #xD; url 1..1 uri "reference" #xD; value[x] 0..1 Reference() Reference to a resource (by instance) #xD; extension:_datatype 0..1 (Complex) Data type name for MedicinalProductDefinition.crossReference.product from FHIR R4B URL: http://hl7.org/fhir/StructureDefinition/_datatype #xD; value[x] 1..1 string Value of extension Fixed Value: CodeableReference #xD; url 1..1 uri "product" #xD; extension:type 0..1 Extension The type of relationship, for instance branded to generic or virtual to actual product #xD; url 1..1 uri "type" #xD; value[x] 0..1 CodeableConcept The type of relationship, for instance branded to generic or virtual to actual product Binding: R4B_medicinal_product_cross_reference_type_for_R4 (0.0.1-snapshot-2) (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. #xD; url 1..1 uri "crossReference" #xD; extension:operation 0..* Extension A manufacturing or administrative process for the medicinal product #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Closed by value:url #xD; extension:type 0..1 Extension The type of manufacturing operation e.g. manufacturing itself, re-packaging #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Closed by value:url #xD; extension:concept 0..1 Extension Reference to a concept (by class) #xD; url 1..1 uri "concept" #xD; value[x] 0..1 CodeableConcept Reference to a concept (by class) #xD; extension:reference 0..1 Extension Reference to a resource (by instance) #xD; url 1..1 uri "reference" #xD; value[x] 0..1 Reference() Reference to a resource (by instance) #xD; extension:_datatype 0..1 (Complex) Data type name for MedicinalProductDefinition.operation.type from FHIR R4B URL: http://hl7.org/fhir/StructureDefinition/_datatype #xD; value[x] 1..1 string Value of extension Fixed Value: CodeableReference #xD; url 1..1 uri "type" #xD; extension:effectiveDate 0..1 Extension Date range of applicability #xD; url 1..1 uri "effectiveDate" #xD; value[x] 0..1 Period Date range of applicability #xD; extension:organization 0..* Extension The organization responsible for the particular process, e.g. the manufacturer or importer #xD; url 1..1 uri "organization" #xD; value[x] 0..1 Reference() The organization responsible for the particular process, e.g. the manufacturer or importer #xD; extension:confidentialityIndicator 0..1 Extension Specifies whether this process is considered proprietary or confidential #xD; url 1..1 uri "confidentialityIndicator" #xD; value[x] 0..1 CodeableConcept Specifies whether this process is considered proprietary or confidential Binding: R4B_medicinal_product_confidentiality_for_R4 (0.0.1-snapshot-2) (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product. #xD; url 1..1 uri "operation" #xD; extension:characteristic 0..* Extension Key product features such as "sugar free", "modified release" #xD; Slices for extension 1..* Extension Extension Slice: Unordered, Closed by value:url #xD; extension:type 1..1 Extension A code expressing the type of characteristic #xD; url 1..1 uri "type" #xD; value[x] 0..1 CodeableConcept A code expressing the type of characteristic Binding: AccountStatus (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. #xD; extension:value[x] 0..1 Extension A value for the characteristic #xD; url 1..1 uri "value[x]" #xD; value[x] 0..1 A value for the characteristic #xD; valueCodeableConcept CodeableConcept #xD; valueQuantity Quantity #xD; valueDate date #xD; valueBoolean boolean #xD; valueAttachment Attachment #xD; url 1..1 uri "characteristic" #xD; url 1..1 uri "http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition" #xD; Documentation for this format
Cross-version Extension for R4B.MedicinalProductDefinition for use in FHIR R4
This cross-version extension represents MedicinalProductDefinition from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
Detailed definition of a medicinal product
A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Must have either extensions or value[x], not both
exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
Regulatory type, e.g. Investigational or Authorized
This cross-version extension represents MedicinalProductDefinition.type from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
Additional content defined by implementations
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Source of the definition for the extension code - a logical name or a URL.
The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Overall defining type of this medicinal product.
If this medicine applies to human or veterinary uses
This cross-version extension represents MedicinalProductDefinition.domain from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
Applicable domain for this product (e.g. human, veterinary).
A business identifier relating to a specific version of the product
A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product.
The status within the lifecycle of this product record
The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status.
The date at which the given status became applicable
This cross-version extension represents MedicinalProductDefinition.statusDate from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
This cross-version extension represents MedicinalProductDefinition.description from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
The dose form for a single part product, or combined form of a multiple part product
The dose form for a single part product, or combined form of a multiple part product. This is one concept that describes all the components. It does not represent the form with components physically mixed, if that might be necessary, for which see (AdministrableProductDefinition.administrableDoseForm).
Dose forms for a product as a whole, considering all individual parts, but before any mixing
The path by which the product is taken into or makes contact with the body
The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route. See also AdministrableProductDefinition resource. MedicinalProductDefinition.route is the same concept as AdministrableProductDefinition.routeOfAdministration.code, and they cannot be used together.
A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
Description of indication(s) for this product, used when structured indications are not required
Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseDefinition resource. An indication is a medical situation for which using the product is appropriate.
The legal status of supply of the medicinal product as classified by the regulator
This cross-version extension represents MedicinalProductDefinition.legalStatusOfSupply from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
The prescription supply types appropriate to a medicinal product
Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirements.
Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).
Whether the Medicinal Product is subject to special measures for regulatory reasons
Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorisation studies.
Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorisation studies.
If authorised for use in children, or infants, neonates etc.
Suitability for age groups, in particular children.
Allows the product to be classified by various systems
Allows the product to be classified by various systems, commonly WHO ATC.
This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
Marketing status of the medicinal product, in contrast to marketing authorization
Marketing status of the medicinal product, in contrast to marketing authorization. This refers to the product being actually 'on the market' as opposed to being allowed to be on the market (which is an authorization).
The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
This cross-version extension represents MarketingStatus.country from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
This cross-version extension represents MarketingStatus.jurisdiction from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
This cross-version extension represents MarketingStatus.status from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
This cross-version extension represents MarketingStatus.dateRange from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
This cross-version extension represents MarketingStatus.restoreDate from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
Data type name for MedicinalProductDefinition.marketingStatus from FHIR R4B
Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R5/extensibility.html) for a list).
Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).
Package type for the product. See also the PackagedProductDefinition resource.
The ingredients of this medicinal product - when not detailed in other resources
The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes.
This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products.
A reference to a concept - e.g. the information is identified by its general class to the degree of precision found in the terminology.
A reference to a resource the provides exact details about the information being referenced.
Data type name for MedicinalProductDefinition.impurity from FHIR R4B
Additional documentation about the medicinal product
Additional information or supporting documentation about the medicinal product.
A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
A master file for the medicinal product (e.g. Pharmacovigilance System Master File). Drug master files (DMFs) are documents submitted to regulatory agencies to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of drug products.
A product specific contact, person (in a role), or an organization
This cross-version extension represents MedicinalProductDefinition.contact from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
This cross-version extension represents MedicinalProductDefinition.contact.type from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
This cross-version extension represents MedicinalProductDefinition.contact.contact from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
Clinical trials or studies that this product is involved in
This cross-version extension represents MedicinalProductDefinition.clinicalTrial from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
The product's name, including full name and possibly coded parts
This cross-version extension represents MedicinalProductDefinition.name from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
This cross-version extension represents MedicinalProductDefinition.name.productName from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
This cross-version extension represents MedicinalProductDefinition.name.type from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
This cross-version extension represents MedicinalProductDefinition.name.namePart from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
This cross-version extension represents MedicinalProductDefinition.name.namePart.part from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
Identifying type for this part of the name (e.g. strength part)
This cross-version extension represents MedicinalProductDefinition.name.namePart.type from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
Type of part of a name for a Medicinal Product.
Country and jurisdiction where the name applies
Country and jurisdiction where the name applies, and associated language.
Country code for where this name applies
This cross-version extension represents MedicinalProductDefinition.name.countryLanguage.country from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
Jurisdiction code for where this name applies
Jurisdiction code for where this name applies. A jurisdiction may be a sub- or supra-national entity (e.g. a state or a geographic region).
This cross-version extension represents MedicinalProductDefinition.name.countryLanguage.language from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
Reference to another product, e.g. for linking authorised to investigational product
Reference to another product, e.g. for linking authorised to investigational product, or a virtual product.
This cross-version extension represents MedicinalProductDefinition.crossReference.product from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
Data type name for MedicinalProductDefinition.crossReference.product from FHIR R4B
The type of relationship, for instance branded to generic or virtual to actual product
The type of relationship, for instance branded to generic, virtual to actual product, product to development product (investigational), parallel import version.
A manufacturing or administrative process for the medicinal product
A manufacturing or administrative process or step associated with (or performed on) the medicinal product.
The type of manufacturing operation e.g. manufacturing itself, re-packaging
The type of manufacturing operation e.g. manufacturing itself, re-packaging. For the authorization of this, a RegulatedAuthorization would point to the same plan or activity referenced here.
Data type name for MedicinalProductDefinition.operation.type from FHIR R4B
This cross-version extension represents MedicinalProductDefinition.operation.effectiveDate from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
The organization responsible for the particular process, e.g. the manufacturer or importer
The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent.
Specifies whether this process is considered proprietary or confidential
Specifies whether this particular business or manufacturing process is considered proprietary or confidential.
Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
Key product features such as "sugar free", "modified release"
Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import".
A code expressing the type of characteristic
This cross-version extension represents MedicinalProductDefinition.characteristic.type from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.
This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
This cross-version extension represents MedicinalProductDefinition.characteristic.value[x] from http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|4.3.0 for use in FHIR R4.