{ "resourceType": "StructureDefinition", "id": "MedicinalProductDefinition", "meta": { "lastUpdated": "2021-01-01T21:58:31.578+00:00" }, "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-category", "valueString": "Specialized.Medication Definition" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "trial-use" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm", "valueInteger": 1 }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category", "valueCode": "anonymous" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode": "brr" }, { "url": "http://hl7.org/fhir/build/StructureDefinition/entered-in-error-status", "valueCode": ".status=entered-in-error" } ], "url": "http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition", "version": "4.6.0", "name": "MedicinalProductDefinition", "status": "draft", "date": "2021-01-01T21:58:31+00:00", "publisher": "Health Level Seven International (Biomedical Research and Regulation)", "contact": [ { "telecom": [ { "system": "url", "value": "http://hl7.org/fhir" } ] }, { "telecom": [ { "system": "url", "value": "http://www.hl7.org/Special/committees/rcrim/index.cfm" } ] } ], "description": "Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use, drug catalogs, to support prescribing, adverse events management etc.).", "fhirVersion": "4.6.0", "mapping": [ { "identity": "idmp", "uri": "https://en.wikipedia.org/wiki/Identification_of_medicinal_products", "name": "IDMP Mapping" }, { "identity": "w5", "uri": "http://hl7.org/fhir/fivews", "name": "FiveWs Pattern Mapping" }, { "identity": "rim", "uri": "http://hl7.org/v3", "name": "RIM Mapping" } ], "kind": "resource", "abstract": false, "type": "MedicinalProductDefinition", "baseDefinition": "http://hl7.org/fhir/StructureDefinition/DomainResource", "derivation": "specialization", "differential": { "element": [ { "id": "MedicinalProductDefinition", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "340,30" } ], "path": "MedicinalProductDefinition", "short": "Detailed definition of a medicinal product", "definition": "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).", "min": 0, "max": "*", "mapping": [ { "identity": "idmp", "map": "Medicinal Product and Investigational Medicinal Product" }, { "identity": "w5", "map": "administrative.medication" } ] }, { "id": "MedicinalProductDefinition.identifier", "path": "MedicinalProductDefinition.identifier", "short": "Business identifier for this product. Could be an MPID", "definition": "Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code.", "alias": [ "MPID" ], "min": 0, "max": "*", "type": [ { "code": "Identifier" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Medicinal Product.MPID, Investigational Medicinal Product.IMPID" } ] }, { "id": "MedicinalProductDefinition.type", "path": "MedicinalProductDefinition.type", "short": "Regulatory type, e.g. Investigational or Authorized", "definition": "Regulatory type, e.g. Investigational or Authorized.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "MedicinalProductType" } ], "strength": "example", "description": "Overall defining type of this medicinal product.", "valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-type" }, "mapping": [ { "identity": "idmp", "map": "(indicates if this is Medicinal Product or an Investigational Medicinal Product)" } ] }, { "id": "MedicinalProductDefinition.domain", "path": "MedicinalProductDefinition.domain", "short": "If this medicine applies to human or veterinary uses", "definition": "If this medicine applies to human or veterinary uses.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "MedicinalProductType" } ], "strength": "example", "description": "Applicable domain for this product (e.g. human, veterinary).", "valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-domain" }, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "MedicinalProductDefinition.version", "path": "MedicinalProductDefinition.version", "short": "A business identifier relating to a specific version of the product", "definition": "A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product.", "min": 0, "max": "1", "type": [ { "code": "string" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Medicinal Product.Header.Version Number" } ] }, { "id": "MedicinalProductDefinition.status", "path": "MedicinalProductDefinition.status", "short": "The status within the lifecycle of this product record", "definition": "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.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isModifier": true, "isModifierReason": "This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid", "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "PublicationStatus" } ], "strength": "preferred", "description": "The lifecycle status of an artifact.", "valueSet": "http://hl7.org/fhir/ValueSet/publication-status" }, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "MedicinalProductDefinition.statusDate", "path": "MedicinalProductDefinition.statusDate", "short": "The date at which the given status became applicable", "definition": "The date at which the given status became applicable.", "min": 0, "max": "1", "type": [ { "code": "dateTime" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "MedicinalProductDefinition.description", "path": "MedicinalProductDefinition.description", "short": "General description of this product", "definition": "General description of this product.", "min": 0, "max": "1", "type": [ { "code": "markdown" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "MedicinalProductDefinition.combinedPharmaceuticalDoseForm", "path": "MedicinalProductDefinition.combinedPharmaceuticalDoseForm", "short": "The dose form for a single part product, or combined form of a multiple part product", "definition": "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).", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "CombinedDoseForm" } ], "strength": "example", "description": "Dose forms for a product as a whole, considering all individual parts, but before any mixing", "valueSet": "http://hl7.org/fhir/ValueSet/combined-dose-form" }, "mapping": [ { "identity": "idmp", "map": "Medicinal Product.Combined Pharmaceutical Dose Form" } ] }, { "id": "MedicinalProductDefinition.route", "path": "MedicinalProductDefinition.route", "short": "The path by which the product is taken into or makes contact with the body", "definition": "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.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "SNOMEDCTRouteCodes" } ], "strength": "example", "description": "A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.", "valueSet": "http://hl7.org/fhir/ValueSet/route-codes" }, "mapping": [ { "identity": "idmp", "map": "Pharmaceutical Product.Route of Administration" } ] }, { "id": "MedicinalProductDefinition.indication", "path": "MedicinalProductDefinition.indication", "short": "Description of indication(s) for this product, used when structured indications are not required", "definition": "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.", "min": 0, "max": "1", "type": [ { "code": "markdown" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "(roll up of all text in Therapeutic Indication.Indication Text, for common case where information is not granular)" } ] }, { "id": "MedicinalProductDefinition.legalStatusOfSupply", "path": "MedicinalProductDefinition.legalStatusOfSupply", "short": "The legal status of supply of the medicinal product as classified by the regulator", "definition": "The legal status of supply of the medicinal product as classified by the regulator.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "LegalStatusOfSupply" } ], "strength": "example", "description": "The prescription supply types appropriate to a medicinal product", "valueSet": "http://hl7.org/fhir/ValueSet/legal-status-of-supply" }, "mapping": [ { "identity": "idmp", "map": "Marketing Authorisation.Legal Status of Supply (moved here for practicality)" } ] }, { "id": "MedicinalProductDefinition.additionalMonitoringIndicator", "path": "MedicinalProductDefinition.additionalMonitoringIndicator", "short": "Whether the Medicinal Product is subject to additional monitoring for regulatory reasons", "definition": "Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirements.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "AdditionalMonitoring" } ], "strength": "example", "description": "Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).", "valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring" }, "mapping": [ { "identity": "idmp", "map": "Medicinal Product.Additional Monitoring Indicator" } ] }, { "id": "MedicinalProductDefinition.specialMeasures", "path": "MedicinalProductDefinition.specialMeasures", "short": "Whether the Medicinal Product is subject to special measures for regulatory reasons", "definition": "Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorisation studies.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "SpecialMeasures" } ], "strength": "example", "description": "Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorisation studies.", "valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-special-measures" }, "mapping": [ { "identity": "idmp", "map": "Medicinal Product.Special Measures" } ] }, { "id": "MedicinalProductDefinition.pediatricUseIndicator", "path": "MedicinalProductDefinition.pediatricUseIndicator", "short": "If authorised for use in children", "definition": "If authorised for use in children, or infants, neonates etc.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "PediatricUse" } ], "strength": "example", "description": "Suitability for age groups, in particular children.", "valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use" }, "mapping": [ { "identity": "idmp", "map": "Medicinal Product.Pediatric Use Indicator" } ] }, { "id": "MedicinalProductDefinition.classification", "path": "MedicinalProductDefinition.classification", "short": "Allows the product to be classified by various systems", "definition": "Allows the product to be classified by various systems, commonly WHO ATC.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ProductClassification" } ], "strength": "example", "description": "This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.", "valueSet": "http://hl7.org/fhir/ValueSet/product-classification-codes" }, "mapping": [ { "identity": "idmp", "map": "Product Classification.Value" } ] }, { "id": "MedicinalProductDefinition.marketingStatus", "path": "MedicinalProductDefinition.marketingStatus", "short": "Marketing status of the medicinal product, in contrast to marketing authorization", "definition": "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).", "min": 0, "max": "*", "type": [ { "code": "MarketingStatus" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Marketing Status" } ] }, { "id": "MedicinalProductDefinition.packagedMedicinalProduct", "path": "MedicinalProductDefinition.packagedMedicinalProduct", "short": "Package type for the product", "definition": "Package type for the product. See also the PackagedProductDefinition resource.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "MedicinalProductPackageType" } ], "strength": "example", "description": "Types of medicinal product packs", "valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-package-type" }, "mapping": [ { "identity": "idmp", "map": "Packaged Medicinal Product" } ] }, { "id": "MedicinalProductDefinition.ingredient", "path": "MedicinalProductDefinition.ingredient", "short": "The ingredients of this medicinal product - when not detailed in other resources", "definition": "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.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "SNOMEDCTSubstanceCodes" } ], "strength": "example", "description": "This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.", "valueSet": "http://hl7.org/fhir/ValueSet/substance-codes" }, "mapping": [ { "identity": "idmp", "map": "Medicinal Product.Ingredient (see also FHIR Ingredient resource)" } ] }, { "id": "MedicinalProductDefinition.impurity", "path": "MedicinalProductDefinition.impurity", "short": "Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product", "definition": "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.", "min": 0, "max": "*", "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition" ] } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "SNOMEDCTSubstanceCodes" } ], "strength": "example", "description": "This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.", "valueSet": "http://hl7.org/fhir/ValueSet/substance-codes" }, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "MedicinalProductDefinition.attachedDocument", "path": "MedicinalProductDefinition.attachedDocument", "short": "Additional documentation about the medicinal product", "definition": "Additional information or supporting documentation about the medicinal product.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DocumentReference" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Attached Document" } ] }, { "id": "MedicinalProductDefinition.masterFile", "path": "MedicinalProductDefinition.masterFile", "short": "A master file for the medicinal product (e.g. Pharmacovigilance System Master File)", "definition": "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.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DocumentReference" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Master File" } ] }, { "id": "MedicinalProductDefinition.contact", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "800,250" } ], "path": "MedicinalProductDefinition.contact", "short": "A product specific contact, person (in a role), or an organization", "definition": "A product specific contact, person (in a role), or an organization.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "MedicinalProductDefinition.contact.type", "path": "MedicinalProductDefinition.contact.type", "short": "Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information", "definition": "Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ProductContactType" } ], "strength": "example", "description": "Extra measures defined for a Medicinal Product, such as heightened reporting requirements.", "valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-contact-type" }, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "MedicinalProductDefinition.contact.contact", "path": "MedicinalProductDefinition.contact.contact", "short": "A product specific contact, person (in a role), or an organization", "definition": "A product specific contact, person (in a role), or an organization.", "min": 1, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization", "http://hl7.org/fhir/StructureDefinition/PractitionerRole" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "MedicinalProductDefinition.clinicalTrial", "path": "MedicinalProductDefinition.clinicalTrial", "short": "Clinical trials or studies that this product is involved in", "definition": "Clinical trials or studies that this product is involved in.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ResearchStudy" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Investigational Medicinal Product.Clinical Trial Status" } ] }, { "id": "MedicinalProductDefinition.code", "path": "MedicinalProductDefinition.code", "short": "A code that this product is known by, within some formal terminology", "definition": "A code that this product is known by, usually within some formal terminology, perhaps assigned by a third party (i.e. not the manufacturer or regulator). Products (types of medications) tend to be known by identifiers during development and within regulatory process. However when they are prescribed they tend to be identified by codes. The same product may be have multiple codes, applied to it by multiple organizations.", "min": 0, "max": "*", "type": [ { "code": "Coding" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "MedicationFormalRepresentation" } ], "strength": "example", "description": "A coded concept that defines the type of a medication.", "valueSet": "http://hl7.org/fhir/ValueSet/medication-codes" }, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "MedicinalProductDefinition.name", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "60,201" } ], "path": "MedicinalProductDefinition.name", "short": "The product's name, including full name and possibly coded parts", "definition": "The product's name, including full name and possibly coded parts.", "min": 1, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Medicinal Product Name" } ] }, { "id": "MedicinalProductDefinition.name.productName", "path": "MedicinalProductDefinition.name.productName", "short": "The full product name", "definition": "The full product name.", "min": 1, "max": "1", "type": [ { "code": "string" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Medicinal Product Name.Full Name" } ] }, { "id": "MedicinalProductDefinition.name.type", "path": "MedicinalProductDefinition.name.type", "short": "Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary", "definition": "Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ProductNameType" } ], "strength": "example", "description": "Type of a name for a Medicinal Product.", "valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-name-type" }, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "MedicinalProductDefinition.name.namePart", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "50,315" } ], "path": "MedicinalProductDefinition.name.namePart", "short": "Coding words or phrases of the name", "definition": "Coding words or phrases of the name.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "(any and all of the name parts e.g. Medicinal Product Name.Formulation Part)" } ] }, { "id": "MedicinalProductDefinition.name.namePart.part", "path": "MedicinalProductDefinition.name.namePart.part", "short": "A fragment of a product name", "definition": "A fragment of a product name.", "min": 1, "max": "1", "type": [ { "code": "string" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "(text of any of the name parts e.g. Medicinal Product Name.Formulation Part)" } ] }, { "id": "MedicinalProductDefinition.name.namePart.type", "path": "MedicinalProductDefinition.name.namePart.type", "short": "Identifying type for this part of the name (e.g. strength part)", "definition": "Identifying type for this part of the name (e.g. strength part).", "min": 1, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ProductNamePartType" } ], "strength": "example", "description": "Type of part of a name for a Medicinal Product.", "valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type" }, "mapping": [ { "identity": "idmp", "map": "(which of the name parts this is e.g. Formulation Part)" } ] }, { "id": "MedicinalProductDefinition.name.countryLanguage", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "30,70" } ], "path": "MedicinalProductDefinition.name.countryLanguage", "short": "Country and jurisdiction where the name applies", "definition": "Country and jurisdiction where the name applies, and associated language.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Country / Language" } ] }, { "id": "MedicinalProductDefinition.name.countryLanguage.country", "path": "MedicinalProductDefinition.name.countryLanguage.country", "short": "Country code for where this name applies", "definition": "Country code for where this name applies.", "min": 1, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "Country" } ], "strength": "example", "description": "Jurisdiction codes", "valueSet": "http://hl7.org/fhir/ValueSet/country" }, "mapping": [ { "identity": "idmp", "map": "Country / Language.Country" } ] }, { "id": "MedicinalProductDefinition.name.countryLanguage.jurisdiction", "path": "MedicinalProductDefinition.name.countryLanguage.jurisdiction", "short": "Jurisdiction code for where this name applies", "definition": "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).", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "Jurisdiction" } ], "strength": "example", "description": "Jurisdiction codes", "valueSet": "http://hl7.org/fhir/ValueSet/jurisdiction" }, "mapping": [ { "identity": "idmp", "map": "Country / Language.Jurisdiction" } ] }, { "id": "MedicinalProductDefinition.name.countryLanguage.language", "path": "MedicinalProductDefinition.name.countryLanguage.language", "short": "Language code for this name", "definition": "Language code for this name.", "min": 1, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/definition", "valueString": "A human language." }, { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet", "valueCanonical": "http://hl7.org/fhir/ValueSet/all-languages" }, { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "Language" }, { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding", "valueBoolean": true } ], "strength": "preferred", "description": "IETF language tag", "valueSet": "http://hl7.org/fhir/ValueSet/languages" }, "mapping": [ { "identity": "idmp", "map": "Country / Language.Language" } ] }, { "id": "MedicinalProductDefinition.crossReference", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "800,10" } ], "path": "MedicinalProductDefinition.crossReference", "short": "Reference to another product, e.g. for linking authorised to investigational product", "definition": "Reference to another product, e.g. for linking authorised to investigational product, or a virtual product.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Product Cross-Reference" } ] }, { "id": "MedicinalProductDefinition.crossReference.product", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "Wanted to make this a choice of identifier or reference to MedicinalProductDefinition but that cannot be 0..*." } ], "path": "MedicinalProductDefinition.crossReference.product", "short": "Reference to another product, e.g. for linking authorised to investigational product", "definition": "Reference to another product, e.g. for linking authorised to investigational product.", "min": 1, "max": "1", "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Product Cross-Reference" } ] }, { "id": "MedicinalProductDefinition.crossReference.type", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes", "valueString": "Wanted to make this a choice of identifier or reference to MedicinalProductDefinition but that cannot be 0..*." } ], "path": "MedicinalProductDefinition.crossReference.type", "short": "The type of relationship, for instance branded to generic or virtual to actual product", "definition": "The type of relationship, for instance branded to generic, virtual to actual product, product to development product (investigational), parallel import version.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ProductCrossReferenceType" } ], "strength": "example", "description": "Extra measures defined for a Medicinal Product, such as heightened reporting requirements.", "valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type" }, "mapping": [ { "identity": "idmp", "map": "Product Cross-Reference" } ] }, { "id": "MedicinalProductDefinition.operation", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "800,110" } ], "path": "MedicinalProductDefinition.operation", "short": "A manufacturing or administrative process for the medicinal product", "definition": "A manufacturing or administrative process or step associated with (or performed on) the medicinal product.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Manufacturing / Business Operation" } ] }, { "id": "MedicinalProductDefinition.operation.type", "path": "MedicinalProductDefinition.operation.type", "short": "The type of manufacturing operation e.g. manufacturing itself, re-packaging", "definition": "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.", "min": 0, "max": "1", "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ActivityDefinition", "http://hl7.org/fhir/StructureDefinition/PlanDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Manufacturing / Business Operation.Operation Type" } ] }, { "id": "MedicinalProductDefinition.operation.effectiveDate", "path": "MedicinalProductDefinition.operation.effectiveDate", "short": "Date range of applicability", "definition": "Date range of applicability.", "min": 0, "max": "1", "type": [ { "code": "Period" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Manufacturing / Business Operation.Effective Date" } ] }, { "id": "MedicinalProductDefinition.operation.organization", "path": "MedicinalProductDefinition.operation.organization", "short": "The organization responsible for the particular process, e.g. the manufacturer or importer", "definition": "The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Manufacturer / Establishment (Organisation)" } ] }, { "id": "MedicinalProductDefinition.operation.confidentialityIndicator", "path": "MedicinalProductDefinition.operation.confidentialityIndicator", "short": "Specifies whether this process is considered proprietary or confidential", "definition": "Specifies whether this particular business or manufacturing process is considered proprietary or confidential.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ProductConfidentiality" } ], "strength": "example", "description": "Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.", "valueSet": "http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality" }, "mapping": [ { "identity": "idmp", "map": "Manufacturing / Business Operation.Confidentiality Indicator" } ] }, { "id": "MedicinalProductDefinition.characteristic", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "800,350" } ], "path": "MedicinalProductDefinition.characteristic", "short": "Key product features such as \"sugar free\", \"modified release\"", "definition": "Allows the key product features to be recorded, such as \"sugar free\", \"modified release\", \"parallel import\".", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Package Item (Container).Physical Characteristics" } ] }, { "id": "MedicinalProductDefinition.characteristic.type", "path": "MedicinalProductDefinition.characteristic.type", "short": "A code expressing the type of characteristic", "definition": "A code expressing the type of characteristic.", "min": 1, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ProductCharacteristic" } ], "strength": "example", "description": "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.", "valueSet": "http://hl7.org/fhir/ValueSet/product-characteristic-codes" }, "mapping": [ { "identity": "idmp", "map": "Physical Characteristics, all attributes" } ] }, { "id": "MedicinalProductDefinition.characteristic.value[x]", "path": "MedicinalProductDefinition.characteristic.value[x]", "short": "A value for the characteristic", "definition": "A value for the characteristic.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" }, { "code": "Quantity" }, { "code": "date" }, { "code": "boolean" }, { "code": "Attachment" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Physical Characteristics, attribute's value" } ] } ] } }