{ "resourceType": "StructureDefinition", "url": "https://noma.no/fhir/StructureDefinition/MedicinalProduct_NOMA_v3_0", "version": "3.0", "name": "MedicinalProduct_NOMA_v3_0", "title": "MedicinalProduct_NOMA_v3_0", "status": "active", "description": "Representing the Medicinal Products approved to be marketed in the Norwegian market. May also represent Nutrition Products.", "fhirVersion": "4.0.1", "kind": "resource", "abstract": false, "type": "MedicinalProduct", "baseDefinition": "http://hl7.org/fhir/StructureDefinition/MedicinalProduct", "derivation": "constraint", "differential": { "element": [ { "id": "MedicinalProduct", "path": "MedicinalProduct", "short": "Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use) TEST TESST" }, { "id": "MedicinalProduct.extension:authorizedPharmaceuticalDoseForm", "path": "MedicinalProduct.extension", "sliceName": "authorizedPharmaceuticalDoseForm", "definition": "Representing the Authorized Pharmaceutical Dose form for the medicinal product. This may be one of the following types, each defined by a separate Code System. All codes are EDQM codes, except local Norwegian codes not present in EDQM, which are published as supplement.\r\n\r\n###### Pharmaceutical Dose Form \r\nIn this case, the Authorized Pharmaceutical Dose Form is equal to the Manufactured Dose Form on the Manufactured Item \r\n**System URL:** [https://mpd.noma.no/codesystem/pharmaceutical-dose-form](https://mpd.noma.no/codesystem/pharmaceutical-dose-form) \r\n**Supplement System URL:** [https://mpd.noma.no/codesystem/pharmaceutical-dose-form-supplement](https://mpd.noma.no/codesystem/pharmaceutical-dose-form-supplement)\r\n\r\n###### Combined pharmaceutical dose form \r\n**System URL:** [https://mpd.noma.no/codesystem/combined-pharmaceutical-dose-form](https://mpd.noma.no/codesystem/combined-pharmaceutical-dose-form) \r\n**Supplement System URL:** [https://mpd.noma.no/codesystem/combined-pharmaceutical-dose-form-supplement](https://mpd.noma.no/codesystem/combined-pharmaceutical-dose-form-supplement)\r\n\r\n###### Combined Term \r\n**System URL:** [https://mpd.noma.no/codesystem/combined-term](https://mpd.noma.no/codesystem/combined-term) \r\n**Supplement System URL:** [https://mpd.noma.no/codesystem/combined-term-supplement](https://mpd.noma.no/codesystem/combined-term-supplement) \r\n\r\n###### Combination Pack \r\n**System URL:** [https://mpd.noma.no/codesystem/combination-pack](https://mpd.noma.no/codesystem/combination-pack) \r\n**Supplement System URL:** N/A", "type": [ { "code": "Extension", "profile": [ "https://mpd.noma.no/structuredefinition/authorized-pharmaceutical-dose-form" ] } ], "isModifier": false }, { "id": "MedicinalProduct.extension:nutritionDoseForm", "path": "MedicinalProduct.extension", "sliceName": "nutritionDoseForm", "short": "A Medicinal Product's Nutrition Dose Form.", "definition": "A Medicinal Product's Nutrition Dose Form, in case it is representing a Nutrition Product. \r\nThe URL points to national Nowegian code system used to classify the nutrition dose form. \r\nUtl (preliminary): https://api.legemiddelverket.no/FHIR-R4/CodeSystem/ac8e8700-2554-48eb-af05-d1b8e3e54e9f", "type": [ { "code": "Extension", "profile": [ "http://legemiddelverket.no/fhir/StructureDefinition/medicinalproduct-nutrition-dose-form" ] } ], "meaningWhenMissing": "When missing, the Medicinal Product is not a nutritional product", "isModifier": false }, { "id": "MedicinalProduct.extension:nutritionDoseForm.value[x].coding.code", "path": "MedicinalProduct.extension.value[x].coding.code", "short": "The code of the nutrition dose form" }, { "id": "MedicinalProduct.extension:nutritionDoseForm.value[x].coding.display", "path": "MedicinalProduct.extension.value[x].coding.display", "short": "The name of the nutrition dose form" }, { "id": "MedicinalProduct.identifier", "path": "MedicinalProduct.identifier", "slicing": { "description": "Sliced", "rules": "open" } }, { "id": "MedicinalProduct.identifier:medicinal-product-definition-id", "path": "MedicinalProduct.identifier", "sliceName": "medicinal-product-definition-id", "short": "Equal to the element's ID", "definition": "Equal to the element's ID, specific to NoMA's FHIR API \r\nSystem Url: [https://mpd.noma.no/identifier/medicinal-product-definition-id](https://mpd.noma.no/identifier/medicinal-product-definition-id)", "min": 1, "max": "1" }, { "id": "MedicinalProduct.identifier:medicinal-product-definition-id.use", "path": "MedicinalProduct.identifier.use", "max": "0" }, { "id": "MedicinalProduct.identifier:medicinal-product-definition-id.type", "path": "MedicinalProduct.identifier.type", "max": "0" }, { "id": "MedicinalProduct.identifier:medicinal-product-definition-id.system", "path": "MedicinalProduct.identifier.system", "min": 1, "fixedUri": "https://mpd.noma.no/identifier/medicinal-product-definition-id" }, { "id": "MedicinalProduct.identifier:medicinal-product-definition-id.value", "path": "MedicinalProduct.identifier.value", "min": 1 }, { "id": "MedicinalProduct.identifier:medicinal-product-definition-id.period", "path": "MedicinalProduct.identifier.period", "max": "0" }, { "id": "MedicinalProduct.identifier:medicinal-product-definition-id.assigner", "path": "MedicinalProduct.identifier.assigner", "max": "0" }, { "id": "MedicinalProduct.identifier:legemiddelmerkevareId", "path": "MedicinalProduct.identifier", "sliceName": "legemiddelmerkevareId", "short": "The medicinal product's FEST (legemiddelMerkevare) ID", "definition": "Ensures referential integrity with the medicinal product's representation in the FEST master data. \r\n\r\nThere are cases in which two Medicinal Products (temporarily) reference to the same FEST legemiddekMerkevareId, if there is a change in the medicinal product's invented name. \r\nFurthermore, there are a few medicinal products not referring to any FEST legemiddelMerkevareID, in case of combined medicinal products and multistrength products. \r\n\r\nSystem URL: [https://mpd.noma.no/identifier/fest-legemiddel-merkevare-id](https://mpd.noma.no/identifier/fest-legemiddel-merkevare-id)", "max": "1", "meaningWhenMissing": "When missing, the medicinal product is not represented as a product in the FEST master data. For example if the medicinal product represents a combinationpack or a multi strength package which are not represented as a product in FEST." }, { "id": "MedicinalProduct.identifier:legemiddelmerkevareId.use", "path": "MedicinalProduct.identifier.use", "max": "0" }, { "id": "MedicinalProduct.identifier:legemiddelmerkevareId.type", "path": "MedicinalProduct.identifier.type", "max": "0" }, { "id": "MedicinalProduct.identifier:legemiddelmerkevareId.system", "path": "MedicinalProduct.identifier.system", "min": 1, "fixedUri": "https://mpd.noma.no/identifier/fest-legemiddel-merkevare-id" }, { "id": "MedicinalProduct.identifier:legemiddelmerkevareId.value", "path": "MedicinalProduct.identifier.value", "min": 1 }, { "id": "MedicinalProduct.identifier:legemiddelmerkevareId.assigner", "path": "MedicinalProduct.identifier.assigner", "max": "0" }, { "id": "MedicinalProduct.type", "path": "MedicinalProduct.type", "max": "0" }, { "id": "MedicinalProduct.domain", "path": "MedicinalProduct.domain", "max": "0" }, { "id": "MedicinalProduct.combinedPharmaceuticalDoseForm", "path": "MedicinalProduct.combinedPharmaceuticalDoseForm", "definition": "The dose form for a single part product, or combined form of a multiple part product.", "max": "0" }, { "id": "MedicinalProduct.legalStatusOfSupply", "path": "MedicinalProduct.legalStatusOfSupply", "definition": "Contains the legal status of supply of the medicinal product if every package connected to it has the same status. If there is one or more packages with different statuses, then the legal status of supply will be defined on the package and this element will be empty.\r\n\r\nDetails on the Norwegian code system for Legal Status of Supply: [Finnkode Reseptgruppe](https://finnkode.helsedirektoratet.no/adm/collections/7421?q=7421)\r\nUsually, only the code (e.g. \"C\") and not the display text (e.g. \"Reseptgruppe C\") is used by the consumers. \r\n\r\nSystem URL: [https://mpd.noma.no/codesystem/legal-status-of-supply](https://mpd.noma.no/codesystem/legal-status-of-supply)", "meaningWhenMissing": "When missing, the underlying packages do not all have the same legal status of suppply." }, { "id": "MedicinalProduct.legalStatusOfSupply.coding.system", "path": "MedicinalProduct.legalStatusOfSupply.coding.system", "definition": "(preliminary) https://volven.no/toolws/index.asmx/wsAppInfoSchema?strKveKode=7421", "min": 1 }, { "id": "MedicinalProduct.legalStatusOfSupply.coding.version", "path": "MedicinalProduct.legalStatusOfSupply.coding.version", "max": "0" }, { "id": "MedicinalProduct.legalStatusOfSupply.coding.code", "path": "MedicinalProduct.legalStatusOfSupply.coding.code", "definition": "The letter code for the legal status of supply - A, B, C, F or K", "min": 1 }, { "id": "MedicinalProduct.legalStatusOfSupply.coding.display", "path": "MedicinalProduct.legalStatusOfSupply.coding.display", "definition": "E.g. \"Reseptgruppe C\"" }, { "id": "MedicinalProduct.legalStatusOfSupply.coding.userSelected", "path": "MedicinalProduct.legalStatusOfSupply.coding.userSelected", "max": "0" }, { "id": "MedicinalProduct.additionalMonitoringIndicator", "path": "MedicinalProduct.additionalMonitoringIndicator", "max": "0" }, { "id": "MedicinalProduct.specialMeasures", "path": "MedicinalProduct.specialMeasures", "max": "0" }, { "id": "MedicinalProduct.paediatricUseIndicator", "path": "MedicinalProduct.paediatricUseIndicator", "max": "0" }, { "id": "MedicinalProduct.productClassification", "path": "MedicinalProduct.productClassification", "definition": "Allows the product to be classified by various systems such as ATC.", "comment": "##### Published (optional) classification categorie for the Medicinal Product::\r\n\r\n###### **Medicinal Product Type (Preparattype)**\r\nThe medicinal product type [Finnkode Preparattype Legemidler](https://finnkode.helsedirektoratet.no/adm/collections/7424?q=7424). \r\nCardinality: 0..1 \r\nCode: The medicinal product type code \r\nDisplay: The medicinal product type such as \"Legemiddel\" or \"Enteral ernæring\" \r\nSystem URL: [https://mpd.noma.no/codesystem/preparattype](https://mpd.noma.no/codesystem/preparattype)\r\n###### **XEVMPD Medicinal Product Type (Søknadstype)**\r\nThe [SPOR RMS classification of a medicinal product](https://spor.ema.europa.eu/rmswi/#/lists/200000000324/terms) according to how itt is authorised. Only used if the medicinal product has been Parallel imported \r\nCardinality: 0..1 \r\nCode: The SPOR RMS code for the classification \r\nDisplay: THe SPOR RMS name for the classification \r\nSystem URL: [https://mpd.noma.no/codesystem/xevmpd-medicinal-product-type](https://mpd.noma.no/codesystem/xevmpd-medicinal-product-type)\r\n###### **Søknadstype godkjenningsfritak**\r\nWhether dispensing the medicinal product requires individual authorisation by the Norwegian Medicinal Agency, is at the discretion of the dispenser or can be dispensed without any further considerations. Code system published at [Finnkode Søknadstyper](https://finnkode.helsedirektoratet.no/adm/collections/7422?q=7422) \r\nCardinality: 0..1 \r\nCode: According to the code system \r\nDisplay: According to the code system \r\nSystem URL): [https://mpd.noma.no/codesystem/soknadstype](https://mpd.noma.no/codesystem/soknadstype)\r\n###### **Har utvidet ernæringsinformasjon**\r\nWhether the Medicinal Product has expanded nutritional information such as vitamins and minerals. Used for paranteral nutrition. \r\nCardinality: 0..1 \r\nCode: \"true\" \r\nDisplay: \"Har utvidet ernæringsinformasjon\" \r\nSystem URL): [https://mpd.noma.no/codesystem/is-parenteral-nutrition](https://mpd.noma.no/codesystem/is-parenteral-nutrition)\r\n###### **ATC codes**\r\nAll the medicinal product's ATC code(s). One entry per code. May represent combination of substances according to the medicinal product's ingredients. \r\nCardinality: 0..* \r\nCode: The ATC code \r\nDisplay: The (substances) name \r\nUrls (preliminary), one per first-level ATC: \r\n\r\n| ATC Category Name | Source | URL (GUPRI) |\r\n| :------- | :------ |:------ |\r\n| ATC (A) Alimentary tract and metabolism | WHO | [https://mpd.noma.no/codesystem/atc-a-alimentary-tract-and-metabolism](https://mpd.noma.no/codesystem/atc-a-alimentary-tract-and-metabolism) |\r\n| ATC (J) Antiinfectives | WHO | [https://mpd.noma.no/codesystem/atc-j-antiinfectives-for-systemic-use](https://mpd.noma.no/codesystem/atc-j-antiinfectives-for-systemic-use) |\r\n| ATC (L) Antineoplastic, immunomodulating agents | WHO | [https://mpd.noma.no/codesystem/atc-l-antineoplastic-and-immunomodulating-agents](https://mpd.noma.no/codesystem/atc-l-antineoplastic-and-immunomodulating-agents) |\r\n| ATC (P) Antiparasitic Products | WHO | [https://mpd.noma.no/codesystem/atc-p-antiparasitic-products-insecticides-and-repellents](https://mpd.noma.no/codesystem/atc-p-antiparasitic-products-insecticides-and-repellents) |\r\n| ATC (B) Blood, Blood Forming Organs | WHO | [https://mpd.noma.no/codesystem/atc-b-blood-and-blood-forming-organs](https://mpd.noma.no/codesystem/atc-b-blood-and-blood-forming-organs) |\r\n| ATC (C) Cardiovascular System | WHO | [https://mpd.noma.no/codesystem/atc-c-cardiovascular-system](https://mpd.noma.no/codesystem/atc-c-cardiovascular-system) |\r\n| ATC (D) Dermatologicals | WHO | [https://mpd.noma.no/codesystem/atc-d-dermatologicals](https://mpd.noma.no/codesystem/atc-d-dermatologicals) |\r\n| ATC (G) Genito urinary System | WHO | [https://mpd.noma.no/codesystem/atc-g-genito-urinary-system-and-sex-hormones](https://mpd.noma.no/codesystem/atc-g-genito-urinary-system-and-sex-hormones) |\r\n| ATC (M) Musculo-skeletal System | WHO | [https://mpd.noma.no/codesystem/atc-m-musculo-skeletal-system](https://mpd.noma.no/codesystem/atc-m-musculo-skeletal-system) |\r\n| ATC (N) Nervous system | WHO | [https://mpd.noma.no/codesystem/atc-n-nervous-system](https://mpd.noma.no/codesystem/atc-n-nervous-system) |\r\n| ATC (R) Respiratory System | WHO | [https://mpd.noma.no/codesystem/atc-r-respiratory-system](https://mpd.noma.no/codesystem/atc-r-respiratory-system) |\r\n| ATC (S) Sensory Organs | WHO | [https://mpd.noma.no/codesystem/atc-s-sensory-organs](https://mpd.noma.no/codesystem/atc-s-sensory-organs) |\r\n| ATC (H) Systemic Hormonal Preparations | WHO | [https://mpd.noma.no/codesystem/atc-h-systemic-hormonal-preparations-excl-sex-hormones-and-insulins](https://mpd.noma.no/codesystem/atc-h-systemic-hormonal-preparations-excl-sex-hormones-and-insulins) |\r\n| ATC (V) Various | WHO | [https://mpd.noma.no/codesystem/atc-v-various](https://mpd.noma.no/codesystem/atc-v-various) |" }, { "id": "MedicinalProduct.productClassification.coding.system", "path": "MedicinalProduct.productClassification.coding.system", "min": 1 }, { "id": "MedicinalProduct.productClassification.coding.version", "path": "MedicinalProduct.productClassification.coding.version", "max": "0" }, { "id": "MedicinalProduct.productClassification.coding.code", "path": "MedicinalProduct.productClassification.coding.code", "min": 1 }, { "id": "MedicinalProduct.productClassification.coding.userSelected", "path": "MedicinalProduct.productClassification.coding.userSelected", "max": "0" }, { "id": "MedicinalProduct.marketingStatus", "path": "MedicinalProduct.marketingStatus", "max": "0" }, { "id": "MedicinalProduct.pharmaceuticalProduct", "path": "MedicinalProduct.pharmaceuticalProduct", "max": "0" }, { "id": "MedicinalProduct.packagedMedicinalProduct", "path": "MedicinalProduct.packagedMedicinalProduct", "min": 1, "type": [ { "code": "Reference", "targetProfile": [ "https://noma.no/fhir/StructureDefinition/MedicinalProductPackaged_NOMA_v3_0" ] } ] }, { "id": "MedicinalProduct.packagedMedicinalProduct.reference", "path": "MedicinalProduct.packagedMedicinalProduct.reference", "min": 1 }, { "id": "MedicinalProduct.packagedMedicinalProduct.type", "path": "MedicinalProduct.packagedMedicinalProduct.type", "min": 1 }, { "id": "MedicinalProduct.packagedMedicinalProduct.identifier", "path": "MedicinalProduct.packagedMedicinalProduct.identifier", "max": "0" }, { "id": "MedicinalProduct.packagedMedicinalProduct.display", "path": "MedicinalProduct.packagedMedicinalProduct.display", "max": "0" }, { "id": "MedicinalProduct.attachedDocument", "path": "MedicinalProduct.attachedDocument", "max": "0" }, { "id": "MedicinalProduct.masterFile", "path": "MedicinalProduct.masterFile", "max": "0" }, { "id": "MedicinalProduct.contact", "path": "MedicinalProduct.contact", "max": "0" }, { "id": "MedicinalProduct.clinicalTrial", "path": "MedicinalProduct.clinicalTrial", "max": "0" }, { "id": "MedicinalProduct.name", "path": "MedicinalProduct.name", "definition": "The product's name, including full name and possibly coded parts.\r\nFor now, only the \"intended name\" part is being published." }, { "id": "MedicinalProduct.name.namePart.type", "path": "MedicinalProduct.name.namePart.type", "definition": "Idenifying type for this part of the name (e.g. strength part). \r\n\r\nName part types are coded using SPOR RMS. \r\nSystem Url: [https://mpd.noma.no/codesystem/medicinal-product-name-part-type](https://mpd.noma.no/codesystem/medicinal-product-name-part-type)" }, { "id": "MedicinalProduct.name.namePart.type.system", "path": "MedicinalProduct.name.namePart.type.system", "min": 1 }, { "id": "MedicinalProduct.name.namePart.type.version", "path": "MedicinalProduct.name.namePart.type.version", "max": "0" }, { "id": "MedicinalProduct.name.namePart.type.code", "path": "MedicinalProduct.name.namePart.type.code", "min": 1 }, { "id": "MedicinalProduct.name.namePart.type.userSelected", "path": "MedicinalProduct.name.namePart.type.userSelected", "max": "0" }, { "id": "MedicinalProduct.name.countryLanguage", "path": "MedicinalProduct.name.countryLanguage", "max": "0" }, { "id": "MedicinalProduct.crossReference", "path": "MedicinalProduct.crossReference", "max": "0" }, { "id": "MedicinalProduct.manufacturingBusinessOperation", "path": "MedicinalProduct.manufacturingBusinessOperation", "max": "0" }, { "id": "MedicinalProduct.specialDesignation", "path": "MedicinalProduct.specialDesignation", "max": "0" } ] } }