Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot
This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR v5.0.0-ballot. . For a full list of available versions, see the Directory of published versions 
| Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi | Version: 1.0.0-ballot | |||
| Active as of 2022-12-04 | Computable Name: MedicinalProductDefinitionUvEpi | |||
Description of the packaged authorized medicinal product(s) associated to this ePI document.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from MedicinalProductDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  MedicinalProductDefinition | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product | |
  identifier | 1..* | Identifier | Unique identifier assigned to this medicinal product by the health authority. Could be the ISO IDMP Medicinal Product Identifier (MPID). | |
  system | 1..1 | uri | The namespace for the identifier value Binding: MedicinalProductDefinition identifier systems (extensible) | |
 value | 1..1 | string | The value that is unique | |
| type | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized Binding: Medicinal Product Type (preferred) | |
| domain | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses Binding: MedicinalProductDomain (preferred) | |
| version | 0..1 | string | Business version of this product | |
| status | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: PublicationStatus (preferred) | |
| statusDate | 0..1 | dateTime | The date at which this status became applicable. | |
| description | 0..1 | markdown | General description of the medicinal product referred by the ePI | |
| combinedPharmaceuticalDoseForm | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: Combined Pharmaceutical Dose Form (preferred) | |
| route | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: Route Of Administration (preferred) | |
| indication | 0..1 | markdown | Narrative text of the authorized indication(s) for this product. | |
| legalStatusOfSupply | 0..1 | CodeableConcept | The legal status of supply of the medicinal product as classified by the regulator Binding: Legal Status for the Supply (preferred) | |
| additionalMonitoringIndicator | 0..1 | CodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: Additional Monitoring Indicator (preferred) | |
| pediatricUseIndicator | 0..1 | CodeableConcept | If authorised for use in children Binding: Pediatric Use Indicator (preferred) | |
| classification | 0..* | CodeableConcept | Allows the product to be classified by various systems Binding: WHO ATC (preferred) | |
| marketingStatus | 0..* | MarketingStatus | Marketing status of the medicinal product in contrast to marketing authorization | |
| status | 1..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 Binding: Marketing Status (preferred) | |
| packagedMedicinalProduct | 0..* | CodeableConcept | High level package type for this product. E.g., sample pack Binding: High level Pack Type (preferred) | |
| name | ||||
| productName | 1..1 | string | The full name of this product Example general: Humalog Mix50 Insulin KwikPen, 3 ml pre-fill | |
| type | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Required Pattern: At least the following | |
  coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
 system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000001 | |
 Slices for part | 0..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by pattern:type | |
  part:ProprietaryNamePart | 0..* | BackboneElement | Coding words or phrases of the name | |
  part | 1..1 | string | brand name of this product Example Example brand name: Humalog Mix50 | |
 type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following | |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000002 | |
| part:Non-proprietaryNamePart | 0..* | BackboneElement | Coding words or phrases of the name | |
| part | 1..1 | string | International Non-proprietary Name (INN) of this product Example Example INN: Insulin lispro | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following | |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000003 | |
| part:StrengthPart | 0..* | BackboneElement | Coding words or phrases of the name | |
| part | 1..1 | string | strength expressed as the quantity of active ingredient Example Example quantity: 100 units/ml | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following | |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000004 | |
 part:PharmaceuticalDoseFormPart | 0..* | BackboneElement | Coding words or phrases of the name | |
| part | 1..1 | string | Physical manifestation of a product as intended to be delivered to the patient. Example Example dose form: solution for injection | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following | |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000005 | |
| usage | ||||
| country | 1..1 | CodeableConcept | Country code for where this name applies Binding: ISO Country two letter code (preferred) | |
| jurisdiction | 0..1 | CodeableConcept | Jurisdiction code for where this name applies Binding: ISO Country two letter code (preferred) | |
| crossReference | ||||
| type | 0..1 | CodeableConcept | The type of relationship, for instance branded to generic or virtual to actual product Binding: ProductCrossReferenceType (extensible) | |
| operation | ||||
| type | 0..1 | CodeableReference(ActivityDefinition | PlanDefinition) | The type of manufacturing operation e.g. manufacturing itself, re-packaging Binding: Type of operation (preferred) | |
| concept | 1..1 | CodeableConcept | Reference to a concept (by class) | |
 organization | 0..* | Reference(Organization (ePI)) | The organization responsible for the particular process, e.g. the manufacturer or importer | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| MedicinalProductDefinition.identifier.system | extensible | VsMedProductIdSystems |
| MedicinalProductDefinition.type | preferred | VsMedProductType (a valid code from https://spor.ema.europa.eu/rmswi/200000025915) |
| MedicinalProductDefinition.domain | preferred | MedicinalProductDomain |
| MedicinalProductDefinition.status | preferred | PublicationStatus |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | preferred | VsPharmaceuticalDoseForm (a valid code from https://spor.ema.europa.eu/rmswi/200000000006) |
| MedicinalProductDefinition.route | preferred | VsRouteOfAdministration (a valid code from https://spor.ema.europa.eu/rmswi/100000073345) |
| MedicinalProductDefinition.legalStatusOfSupply | preferred | VsLegalStatusOfSupply (a valid code from https://spor.ema.europa.eu/rmswi/100000072051) |
| MedicinalProductDefinition.additionalMonitoringIndicator | preferred | VsAdditionalMonitoringIndicator (a valid code from http://example.org) |
| MedicinalProductDefinition.pediatricUseIndicator | preferred | VsPediatricUseIndicator (a valid code from http://example.org) |
| MedicinalProductDefinition.classification | preferred | VsAtcClassification |
| MedicinalProductDefinition.marketingStatus.status | preferred | VsMarketingStatus (a valid code from https://spor.ema.europa.eu/rmswi/100000072052) |
| MedicinalProductDefinition.packagedMedicinalProduct | preferred | VsPackageType |
| MedicinalProductDefinition.name.usage.country | preferred | VsCountry |
| MedicinalProductDefinition.name.usage.jurisdiction | preferred | VsCountry |
| MedicinalProductDefinition.crossReference.type | extensible | ProductCrossReferenceType |
| MedicinalProductDefinition.operation.type | preferred | VsOperationType (a valid code from http://example.org) |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| MedicinalProductDefinition | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product | |
 implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
 identifier | Σ | 1..* | Identifier | Unique identifier assigned to this medicinal product by the health authority. Could be the ISO IDMP Medicinal Product Identifier (MPID). |
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required) |
| system | Σ | 1..1 | uri | The namespace for the identifier value Binding: MedicinalProductDefinition identifier systems (extensible) Example General: http://www.acme.com/identifiers/patient |
| value | Σ | 1..1 | string | The value that is unique Example General: 123456 |
| type | Σ | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized Binding: Medicinal Product Type (preferred) |
| domain | Σ | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses Binding: MedicinalProductDomain (preferred) |
| version | Σ | 0..1 | string | Business version of this product |
| status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: PublicationStatus (preferred) |
| statusDate | Σ | 0..1 | dateTime | The date at which this status became applicable. |
| description | Σ | 0..1 | markdown | General description of the medicinal product referred by the ePI |
| combinedPharmaceuticalDoseForm | Σ | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: Combined Pharmaceutical Dose Form (preferred) |
| route | Σ | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: Route Of Administration (preferred) |
| indication | Σ | 0..1 | markdown | Narrative text of the authorized indication(s) for this product. |
| legalStatusOfSupply | Σ | 0..1 | CodeableConcept | The legal status of supply of the medicinal product as classified by the regulator Binding: Legal Status for the Supply (preferred) |
| additionalMonitoringIndicator | Σ | 0..1 | CodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: Additional Monitoring Indicator (preferred) |
| pediatricUseIndicator | Σ | 0..1 | CodeableConcept | If authorised for use in children Binding: Pediatric Use Indicator (preferred) |
| classification | Σ | 0..* | CodeableConcept | Allows the product to be classified by various systems Binding: WHO ATC (preferred) |
| marketingStatus | Σ | 0..* | MarketingStatus | Marketing status of the medicinal product in contrast to marketing authorization |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..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 Binding: Marketing Status (preferred) |
| packagedMedicinalProduct | Σ | 0..* | CodeableConcept | High level package type for this product. E.g., sample pack Binding: High level Pack Type (preferred) |
| name | Σ | 1..* | BackboneElement | The product's name, including full name and possibly coded parts |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| productName | Σ | 1..1 | string | The full name of this product Example general: Humalog Mix50 Insulin KwikPen, 3 ml pre-fill |
| type | Σ | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product. Required Pattern: At least the following |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000001 | |
| Slices for part | Σ | 0..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by pattern:type |
| part:All Slices | Content/Rules for all slices | |||
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| part | Σ | 1..1 | string | A fragment of a product name |
 type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. |
| part:ProprietaryNamePart | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| part | Σ | 1..1 | string | brand name of this product Example Example brand name: Humalog Mix50 |
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000002 | |
| part:Non-proprietaryNamePart | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| part | Σ | 1..1 | string | International Non-proprietary Name (INN) of this product Example Example INN: Insulin lispro |
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000003 | |
| part:StrengthPart | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| part | Σ | 1..1 | string | strength expressed as the quantity of active ingredient Example Example quantity: 100 units/ml |
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000004 | |
| part:PharmaceuticalDoseFormPart | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| part | Σ | 1..1 | string | Physical manifestation of a product as intended to be delivered to the patient. Example Example dose form: solution for injection |
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000005 | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code |
| MedicinalProductDefinition.identifier.use | required | IdentifierUse |
| MedicinalProductDefinition.identifier.system | extensible | VsMedProductIdSystems |
| MedicinalProductDefinition.type | preferred | VsMedProductType (a valid code from https://spor.ema.europa.eu/rmswi/200000025915) |
| MedicinalProductDefinition.domain | preferred | MedicinalProductDomain |
| MedicinalProductDefinition.status | preferred | PublicationStatus |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | preferred | VsPharmaceuticalDoseForm (a valid code from https://spor.ema.europa.eu/rmswi/200000000006) |
| MedicinalProductDefinition.route | preferred | VsRouteOfAdministration (a valid code from https://spor.ema.europa.eu/rmswi/100000073345) |
| MedicinalProductDefinition.legalStatusOfSupply | preferred | VsLegalStatusOfSupply (a valid code from https://spor.ema.europa.eu/rmswi/100000072051) |
| MedicinalProductDefinition.additionalMonitoringIndicator | preferred | VsAdditionalMonitoringIndicator (a valid code from http://example.org) |
| MedicinalProductDefinition.pediatricUseIndicator | preferred | VsPediatricUseIndicator (a valid code from http://example.org) |
| MedicinalProductDefinition.classification | preferred | VsAtcClassification |
| MedicinalProductDefinition.marketingStatus.status | preferred | VsMarketingStatus (a valid code from https://spor.ema.europa.eu/rmswi/100000072052) |
| MedicinalProductDefinition.packagedMedicinalProduct | preferred | VsPackageType |
| MedicinalProductDefinition.name.type | example | Pattern: 220000000001 |
| MedicinalProductDefinition.name.part.type | example | ProductNamePartType |
| MedicinalProductDefinition.name.part:ProprietaryNamePart.type | example | Pattern: 220000000002 |
| MedicinalProductDefinition.name.part:Non-proprietaryNamePart.type | example | Pattern: 220000000003 |
| MedicinalProductDefinition.name.part:StrengthPart.type | example | Pattern: 220000000004 |
| MedicinalProductDefinition.name.part:PharmaceuticalDoseFormPart.type | example | Pattern: 220000000005 |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| MedicinalProductDefinition | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product | |||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): IETF language tag
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
 extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 1..* | Identifier | Unique identifier assigned to this medicinal product by the health authority. Could be the ISO IDMP Medicinal Product Identifier (MPID). | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required) | ||||
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible) | ||||
| system | Σ | 1..1 | uri | The namespace for the identifier value Binding: MedicinalProductDefinition identifier systems (extensible) Example General: http://www.acme.com/identifiers/patient | ||||
| value | Σ | 1..1 | string | The value that is unique Example General: 123456 | ||||
| period | Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
| assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
| type | Σ | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized Binding: Medicinal Product Type (preferred) | ||||
| domain | Σ | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses Binding: MedicinalProductDomain (preferred) | ||||
| version | Σ | 0..1 | string | Business version of this product | ||||
| status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: PublicationStatus (preferred) | ||||
| statusDate | Σ | 0..1 | dateTime | The date at which this status became applicable. | ||||
| description | Σ | 0..1 | markdown | General description of the medicinal product referred by the ePI | ||||
| combinedPharmaceuticalDoseForm | Σ | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: Combined Pharmaceutical Dose Form (preferred) | ||||
| route | Σ | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: Route Of Administration (preferred) | ||||
| indication | Σ | 0..1 | markdown | Narrative text of the authorized indication(s) for this product. | ||||
| legalStatusOfSupply | Σ | 0..1 | CodeableConcept | The legal status of supply of the medicinal product as classified by the regulator Binding: Legal Status for the Supply (preferred) | ||||
| additionalMonitoringIndicator | Σ | 0..1 | CodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: Additional Monitoring Indicator (preferred) | ||||
| specialMeasures | Σ | 0..* | CodeableConcept | Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorisation studies. | ||||
| pediatricUseIndicator | Σ | 0..1 | CodeableConcept | If authorised for use in children Binding: Pediatric Use Indicator (preferred) | ||||
| classification | Σ | 0..* | CodeableConcept | Allows the product to be classified by various systems Binding: WHO ATC (preferred) | ||||
| marketingStatus | Σ | 0..* | MarketingStatus | Marketing status of the medicinal product in contrast to marketing authorization | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| country | Σ | 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 | ||||
| jurisdiction | Σ | 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 | ||||
| status | Σ | 1..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 Binding: Marketing Status (preferred) | ||||
| dateRange | Σ | 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 | ||||
| restoreDate | Σ | 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 | ||||
| packagedMedicinalProduct | Σ | 0..* | CodeableConcept | High level package type for this product. E.g., sample pack Binding: High level Pack Type (preferred) | ||||
| comprisedOf | Σ | 0..* | Reference(ManufacturedItemDefinition | DeviceDefinition) | Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes | ||||
| ingredient | Σ | 0..* | CodeableConcept | The ingredients of this medicinal product - when not detailed in other resources Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
| impurity | Σ | 0..* | CodeableReference(SubstanceDefinition) | Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
| attachedDocument | Σ | 0..* | Reference(DocumentReference) | Additional documentation about the medicinal product | ||||
| masterFile | Σ | 0..* | Reference(DocumentReference) | A master file for the medicinal product (e.g. Pharmacovigilance System Master File) | ||||
| contact | Σ | 0..* | BackboneElement | A product specific contact, person (in a role), or an organization | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type | Σ | 0..1 | CodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. | ||||
| contact | Σ | 1..1 | Reference(Organization | PractitionerRole) | A product specific contact, person (in a role), or an organization | ||||
| clinicalTrial | Σ | 0..* | Reference(ResearchStudy) | Clinical trials or studies that this product is involved in | ||||
| code | Σ | 0..* | Coding | A code that this product is known by, within some formal terminology Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication. | ||||
| name | Σ | 1..* | BackboneElement | The product's name, including full name and possibly coded parts | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| productName | Σ | 1..1 | string | The full name of this product Example general: Humalog Mix50 Insulin KwikPen, 3 ml pre-fill | ||||
| type | Σ | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product. Required Pattern: At least the following | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000001 | |||||
| display | 0..1 | string | Representation defined by the system | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | 0..1 | string | Plain text representation of the concept | |||||
| Slices for part | Σ | 0..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by pattern:type | ||||
| part:All Slices | Content/Rules for all slices | |||||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| part | Σ | 1..1 | string | A fragment of a product name | ||||
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. | ||||
| part:ProprietaryNamePart | Σ | 0..* | BackboneElement | Coding words or phrases of the name | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| part | Σ | 1..1 | string | brand name of this product Example Example brand name: Humalog Mix50 | ||||
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000002 | |||||
| display | 0..1 | string | Representation defined by the system | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | 0..1 | string | Plain text representation of the concept | |||||
| part:Non-proprietaryNamePart | Σ | 0..* | BackboneElement | Coding words or phrases of the name | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| part | Σ | 1..1 | string | International Non-proprietary Name (INN) of this product Example Example INN: Insulin lispro | ||||
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000003 | |||||
| display | 0..1 | string | Representation defined by the system | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | 0..1 | string | Plain text representation of the concept | |||||
| part:StrengthPart | Σ | 0..* | BackboneElement | Coding words or phrases of the name | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| part | Σ | 1..1 | string | strength expressed as the quantity of active ingredient Example Example quantity: 100 units/ml | ||||
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000004 | |||||
| display | 0..1 | string | Representation defined by the system | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | 0..1 | string | Plain text representation of the concept | |||||
| part:PharmaceuticalDoseFormPart | Σ | 0..* | BackboneElement | Coding words or phrases of the name | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| part | Σ | 1..1 | string | Physical manifestation of a product as intended to be delivered to the patient. Example Example dose form: solution for injection | ||||
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000005 | |||||
| display | 0..1 | string | Representation defined by the system | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | 0..1 | string | Plain text representation of the concept | |||||
| usage | Σ | 0..* | BackboneElement | Country and jurisdiction where the name applies | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| country | Σ | 1..1 | CodeableConcept | Country code for where this name applies Binding: ISO Country two letter code (preferred) | ||||
| jurisdiction | Σ | 0..1 | CodeableConcept | Jurisdiction code for where this name applies Binding: ISO Country two letter code (preferred) | ||||
| language | Σ | 1..1 | CodeableConcept | Language code for this name Binding: CommonLanguages (preferred): IETF language tag
| ||||
| crossReference | Σ | 0..* | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| product | Σ | 1..1 | CodeableReference(MedicinalProductDefinition) | Reference to another product, e.g. for linking authorised to investigational product | ||||
| type | Σ | 0..1 | CodeableConcept | The type of relationship, for instance branded to generic or virtual to actual product Binding: ProductCrossReferenceType (extensible) | ||||
| operation | Σ | 0..* | BackboneElement | A manufacturing or administrative process for the medicinal product | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type | Σ | 0..1 | CodeableReference(ActivityDefinition | PlanDefinition) | The type of manufacturing operation e.g. manufacturing itself, re-packaging Binding: Type of operation (preferred) | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| concept | Σ | 1..1 | CodeableConcept | Reference to a concept (by class) | ||||
| reference | Σ | 0..1 | Reference() | Reference to a resource (by instance) | ||||
| effectiveDate | Σ | 0..1 | Period | Date range of applicability | ||||
| organization | Σ | 0..* | Reference(Organization (ePI)) | The organization responsible for the particular process, e.g. the manufacturer or importer | ||||
| confidentialityIndicator | Σ | 0..1 | CodeableConcept | Specifies whether this process is considered proprietary or confidential Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product. | ||||
| characteristic | Σ | 0..* | BackboneElement | Key product features such as "sugar free", "modified release" | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type | Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
 value[x] | Σ | 0..1 | A value for the characteristic | |||||
| valueCodeableConcept | CodeableConcept | |||||||
| valueString | string | |||||||
| valueQuantity | Quantity | |||||||
| valueInteger | integer | |||||||
| valueDate | date | |||||||
| valueBoolean | boolean | |||||||
| valueAttachment | Attachment | |||||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | ||||
| MedicinalProductDefinition.language | preferred | CommonLanguages
| ||||
| MedicinalProductDefinition.identifier.use | required | IdentifierUse | ||||
| MedicinalProductDefinition.identifier.type | extensible | Identifier Type Codes | ||||
| MedicinalProductDefinition.identifier.system | extensible | VsMedProductIdSystems | ||||
| MedicinalProductDefinition.type | preferred | VsMedProductType (a valid code from https://spor.ema.europa.eu/rmswi/200000025915) | ||||
| MedicinalProductDefinition.domain | preferred | MedicinalProductDomain | ||||
| MedicinalProductDefinition.status | preferred | PublicationStatus | ||||
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | preferred | VsPharmaceuticalDoseForm (a valid code from https://spor.ema.europa.eu/rmswi/200000000006) | ||||
| MedicinalProductDefinition.route | preferred | VsRouteOfAdministration (a valid code from https://spor.ema.europa.eu/rmswi/100000073345) | ||||
| MedicinalProductDefinition.legalStatusOfSupply | preferred | VsLegalStatusOfSupply (a valid code from https://spor.ema.europa.eu/rmswi/100000072051) | ||||
| MedicinalProductDefinition.additionalMonitoringIndicator | preferred | VsAdditionalMonitoringIndicator (a valid code from http://example.org) | ||||
| MedicinalProductDefinition.specialMeasures | example | SpecialMeasures | ||||
| MedicinalProductDefinition.pediatricUseIndicator | preferred | VsPediatricUseIndicator (a valid code from http://example.org) | ||||
| MedicinalProductDefinition.classification | preferred | VsAtcClassification | ||||
| MedicinalProductDefinition.marketingStatus.status | preferred | VsMarketingStatus (a valid code from https://spor.ema.europa.eu/rmswi/100000072052) | ||||
| MedicinalProductDefinition.packagedMedicinalProduct | preferred | VsPackageType | ||||
| MedicinalProductDefinition.ingredient | example | SNOMEDCTSubstanceCodes | ||||
| MedicinalProductDefinition.impurity | example | SNOMEDCTSubstanceCodes | ||||
| MedicinalProductDefinition.contact.type | example | ProductContactType | ||||
| MedicinalProductDefinition.code | example | SNOMEDCTMedicationCodes | ||||
| MedicinalProductDefinition.name.type | example | Pattern: 220000000001 | ||||
| MedicinalProductDefinition.name.part.type | example | ProductNamePartType | ||||
| MedicinalProductDefinition.name.part:ProprietaryNamePart.type | example | Pattern: 220000000002 | ||||
| MedicinalProductDefinition.name.part:Non-proprietaryNamePart.type | example | Pattern: 220000000003 | ||||
| MedicinalProductDefinition.name.part:StrengthPart.type | example | Pattern: 220000000004 | ||||
| MedicinalProductDefinition.name.part:PharmaceuticalDoseFormPart.type | example | Pattern: 220000000005 | ||||
| MedicinalProductDefinition.name.usage.country | preferred | VsCountry | ||||
| MedicinalProductDefinition.name.usage.jurisdiction | preferred | VsCountry | ||||
| MedicinalProductDefinition.name.usage.language | preferred | CommonLanguages
| ||||
| MedicinalProductDefinition.crossReference.type | extensible | ProductCrossReferenceType | ||||
| MedicinalProductDefinition.operation.type | preferred | VsOperationType (a valid code from http://example.org) | ||||
| MedicinalProductDefinition.operation.confidentialityIndicator | example | ProductConfidentiality | ||||
| MedicinalProductDefinition.characteristic.type | example | ProductCharacteristic |
This structure is derived from MedicinalProductDefinition
Summary
Mandatory: 3 elements (1 nested mandatory element)
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Differential View
This structure is derived from MedicinalProductDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| MedicinalProductDefinition | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product | |
| identifier | 1..* | Identifier | Unique identifier assigned to this medicinal product by the health authority. Could be the ISO IDMP Medicinal Product Identifier (MPID). | |
| system | 1..1 | uri | The namespace for the identifier value Binding: MedicinalProductDefinition identifier systems (extensible) | |
| value | 1..1 | string | The value that is unique | |
| type | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized Binding: Medicinal Product Type (preferred) | |
| domain | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses Binding: MedicinalProductDomain (preferred) | |
| version | 0..1 | string | Business version of this product | |
| status | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: PublicationStatus (preferred) | |
| statusDate | 0..1 | dateTime | The date at which this status became applicable. | |
| description | 0..1 | markdown | General description of the medicinal product referred by the ePI | |
| combinedPharmaceuticalDoseForm | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: Combined Pharmaceutical Dose Form (preferred) | |
| route | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: Route Of Administration (preferred) | |
| indication | 0..1 | markdown | Narrative text of the authorized indication(s) for this product. | |
| legalStatusOfSupply | 0..1 | CodeableConcept | The legal status of supply of the medicinal product as classified by the regulator Binding: Legal Status for the Supply (preferred) | |
| additionalMonitoringIndicator | 0..1 | CodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: Additional Monitoring Indicator (preferred) | |
| pediatricUseIndicator | 0..1 | CodeableConcept | If authorised for use in children Binding: Pediatric Use Indicator (preferred) | |
| classification | 0..* | CodeableConcept | Allows the product to be classified by various systems Binding: WHO ATC (preferred) | |
| marketingStatus | 0..* | MarketingStatus | Marketing status of the medicinal product in contrast to marketing authorization | |
| status | 1..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 Binding: Marketing Status (preferred) | |
| packagedMedicinalProduct | 0..* | CodeableConcept | High level package type for this product. E.g., sample pack Binding: High level Pack Type (preferred) | |
| name | ||||
| productName | 1..1 | string | The full name of this product Example general: Humalog Mix50 Insulin KwikPen, 3 ml pre-fill | |
| type | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Required Pattern: At least the following | |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000001 | |
| Slices for part | 0..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by pattern:type | |
| part:ProprietaryNamePart | 0..* | BackboneElement | Coding words or phrases of the name | |
| part | 1..1 | string | brand name of this product Example Example brand name: Humalog Mix50 | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following | |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000002 | |
| part:Non-proprietaryNamePart | 0..* | BackboneElement | Coding words or phrases of the name | |
| part | 1..1 | string | International Non-proprietary Name (INN) of this product Example Example INN: Insulin lispro | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following | |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000003 | |
| part:StrengthPart | 0..* | BackboneElement | Coding words or phrases of the name | |
| part | 1..1 | string | strength expressed as the quantity of active ingredient Example Example quantity: 100 units/ml | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following | |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000004 | |
| part:PharmaceuticalDoseFormPart | 0..* | BackboneElement | Coding words or phrases of the name | |
| part | 1..1 | string | Physical manifestation of a product as intended to be delivered to the patient. Example Example dose form: solution for injection | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following | |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000005 | |
| usage | ||||
| country | 1..1 | CodeableConcept | Country code for where this name applies Binding: ISO Country two letter code (preferred) | |
| jurisdiction | 0..1 | CodeableConcept | Jurisdiction code for where this name applies Binding: ISO Country two letter code (preferred) | |
| crossReference | ||||
| type | 0..1 | CodeableConcept | The type of relationship, for instance branded to generic or virtual to actual product Binding: ProductCrossReferenceType (extensible) | |
| operation | ||||
| type | 0..1 | CodeableReference(ActivityDefinition | PlanDefinition) | The type of manufacturing operation e.g. manufacturing itself, re-packaging Binding: Type of operation (preferred) | |
| concept | 1..1 | CodeableConcept | Reference to a concept (by class) | |
| organization | 0..* | Reference(Organization (ePI)) | The organization responsible for the particular process, e.g. the manufacturer or importer | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| MedicinalProductDefinition.identifier.system | extensible | VsMedProductIdSystems |
| MedicinalProductDefinition.type | preferred | VsMedProductType (a valid code from https://spor.ema.europa.eu/rmswi/200000025915) |
| MedicinalProductDefinition.domain | preferred | MedicinalProductDomain |
| MedicinalProductDefinition.status | preferred | PublicationStatus |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | preferred | VsPharmaceuticalDoseForm (a valid code from https://spor.ema.europa.eu/rmswi/200000000006) |
| MedicinalProductDefinition.route | preferred | VsRouteOfAdministration (a valid code from https://spor.ema.europa.eu/rmswi/100000073345) |
| MedicinalProductDefinition.legalStatusOfSupply | preferred | VsLegalStatusOfSupply (a valid code from https://spor.ema.europa.eu/rmswi/100000072051) |
| MedicinalProductDefinition.additionalMonitoringIndicator | preferred | VsAdditionalMonitoringIndicator (a valid code from http://example.org) |
| MedicinalProductDefinition.pediatricUseIndicator | preferred | VsPediatricUseIndicator (a valid code from http://example.org) |
| MedicinalProductDefinition.classification | preferred | VsAtcClassification |
| MedicinalProductDefinition.marketingStatus.status | preferred | VsMarketingStatus (a valid code from https://spor.ema.europa.eu/rmswi/100000072052) |
| MedicinalProductDefinition.packagedMedicinalProduct | preferred | VsPackageType |
| MedicinalProductDefinition.name.usage.country | preferred | VsCountry |
| MedicinalProductDefinition.name.usage.jurisdiction | preferred | VsCountry |
| MedicinalProductDefinition.crossReference.type | extensible | ProductCrossReferenceType |
| MedicinalProductDefinition.operation.type | preferred | VsOperationType (a valid code from http://example.org) |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| MedicinalProductDefinition | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product | |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| identifier | Σ | 1..* | Identifier | Unique identifier assigned to this medicinal product by the health authority. Could be the ISO IDMP Medicinal Product Identifier (MPID). |
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required) |
| system | Σ | 1..1 | uri | The namespace for the identifier value Binding: MedicinalProductDefinition identifier systems (extensible) Example General: http://www.acme.com/identifiers/patient |
| value | Σ | 1..1 | string | The value that is unique Example General: 123456 |
| type | Σ | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized Binding: Medicinal Product Type (preferred) |
| domain | Σ | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses Binding: MedicinalProductDomain (preferred) |
| version | Σ | 0..1 | string | Business version of this product |
| status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: PublicationStatus (preferred) |
| statusDate | Σ | 0..1 | dateTime | The date at which this status became applicable. |
| description | Σ | 0..1 | markdown | General description of the medicinal product referred by the ePI |
| combinedPharmaceuticalDoseForm | Σ | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: Combined Pharmaceutical Dose Form (preferred) |
| route | Σ | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: Route Of Administration (preferred) |
| indication | Σ | 0..1 | markdown | Narrative text of the authorized indication(s) for this product. |
| legalStatusOfSupply | Σ | 0..1 | CodeableConcept | The legal status of supply of the medicinal product as classified by the regulator Binding: Legal Status for the Supply (preferred) |
| additionalMonitoringIndicator | Σ | 0..1 | CodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: Additional Monitoring Indicator (preferred) |
| pediatricUseIndicator | Σ | 0..1 | CodeableConcept | If authorised for use in children Binding: Pediatric Use Indicator (preferred) |
| classification | Σ | 0..* | CodeableConcept | Allows the product to be classified by various systems Binding: WHO ATC (preferred) |
| marketingStatus | Σ | 0..* | MarketingStatus | Marketing status of the medicinal product in contrast to marketing authorization |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..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 Binding: Marketing Status (preferred) |
| packagedMedicinalProduct | Σ | 0..* | CodeableConcept | High level package type for this product. E.g., sample pack Binding: High level Pack Type (preferred) |
| name | Σ | 1..* | BackboneElement | The product's name, including full name and possibly coded parts |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| productName | Σ | 1..1 | string | The full name of this product Example general: Humalog Mix50 Insulin KwikPen, 3 ml pre-fill |
| type | Σ | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product. Required Pattern: At least the following |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000001 | |
| Slices for part | Σ | 0..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by pattern:type |
| part:All Slices | Content/Rules for all slices | |||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| part | Σ | 1..1 | string | A fragment of a product name |
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. |
| part:ProprietaryNamePart | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| part | Σ | 1..1 | string | brand name of this product Example Example brand name: Humalog Mix50 |
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000002 | |
| part:Non-proprietaryNamePart | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| part | Σ | 1..1 | string | International Non-proprietary Name (INN) of this product Example Example INN: Insulin lispro |
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000003 | |
| part:StrengthPart | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| part | Σ | 1..1 | string | strength expressed as the quantity of active ingredient Example Example quantity: 100 units/ml |
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000004 | |
| part:PharmaceuticalDoseFormPart | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| part | Σ | 1..1 | string | Physical manifestation of a product as intended to be delivered to the patient. Example Example dose form: solution for injection |
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following |
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000005 | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code |
| MedicinalProductDefinition.identifier.use | required | IdentifierUse |
| MedicinalProductDefinition.identifier.system | extensible | VsMedProductIdSystems |
| MedicinalProductDefinition.type | preferred | VsMedProductType (a valid code from https://spor.ema.europa.eu/rmswi/200000025915) |
| MedicinalProductDefinition.domain | preferred | MedicinalProductDomain |
| MedicinalProductDefinition.status | preferred | PublicationStatus |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | preferred | VsPharmaceuticalDoseForm (a valid code from https://spor.ema.europa.eu/rmswi/200000000006) |
| MedicinalProductDefinition.route | preferred | VsRouteOfAdministration (a valid code from https://spor.ema.europa.eu/rmswi/100000073345) |
| MedicinalProductDefinition.legalStatusOfSupply | preferred | VsLegalStatusOfSupply (a valid code from https://spor.ema.europa.eu/rmswi/100000072051) |
| MedicinalProductDefinition.additionalMonitoringIndicator | preferred | VsAdditionalMonitoringIndicator (a valid code from http://example.org) |
| MedicinalProductDefinition.pediatricUseIndicator | preferred | VsPediatricUseIndicator (a valid code from http://example.org) |
| MedicinalProductDefinition.classification | preferred | VsAtcClassification |
| MedicinalProductDefinition.marketingStatus.status | preferred | VsMarketingStatus (a valid code from https://spor.ema.europa.eu/rmswi/100000072052) |
| MedicinalProductDefinition.packagedMedicinalProduct | preferred | VsPackageType |
| MedicinalProductDefinition.name.type | example | Pattern: 220000000001 |
| MedicinalProductDefinition.name.part.type | example | ProductNamePartType |
| MedicinalProductDefinition.name.part:ProprietaryNamePart.type | example | Pattern: 220000000002 |
| MedicinalProductDefinition.name.part:Non-proprietaryNamePart.type | example | Pattern: 220000000003 |
| MedicinalProductDefinition.name.part:StrengthPart.type | example | Pattern: 220000000004 |
| MedicinalProductDefinition.name.part:PharmaceuticalDoseFormPart.type | example | Pattern: 220000000005 |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| MedicinalProductDefinition | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product | |||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): IETF language tag
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 1..* | Identifier | Unique identifier assigned to this medicinal product by the health authority. Could be the ISO IDMP Medicinal Product Identifier (MPID). | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required) | ||||
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible) | ||||
| system | Σ | 1..1 | uri | The namespace for the identifier value Binding: MedicinalProductDefinition identifier systems (extensible) Example General: http://www.acme.com/identifiers/patient | ||||
| value | Σ | 1..1 | string | The value that is unique Example General: 123456 | ||||
| period | Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
| assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
| type | Σ | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized Binding: Medicinal Product Type (preferred) | ||||
| domain | Σ | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses Binding: MedicinalProductDomain (preferred) | ||||
| version | Σ | 0..1 | string | Business version of this product | ||||
| status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: PublicationStatus (preferred) | ||||
| statusDate | Σ | 0..1 | dateTime | The date at which this status became applicable. | ||||
| description | Σ | 0..1 | markdown | General description of the medicinal product referred by the ePI | ||||
| combinedPharmaceuticalDoseForm | Σ | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: Combined Pharmaceutical Dose Form (preferred) | ||||
| route | Σ | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: Route Of Administration (preferred) | ||||
| indication | Σ | 0..1 | markdown | Narrative text of the authorized indication(s) for this product. | ||||
| legalStatusOfSupply | Σ | 0..1 | CodeableConcept | The legal status of supply of the medicinal product as classified by the regulator Binding: Legal Status for the Supply (preferred) | ||||
| additionalMonitoringIndicator | Σ | 0..1 | CodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: Additional Monitoring Indicator (preferred) | ||||
| specialMeasures | Σ | 0..* | CodeableConcept | Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorisation studies. | ||||
| pediatricUseIndicator | Σ | 0..1 | CodeableConcept | If authorised for use in children Binding: Pediatric Use Indicator (preferred) | ||||
| classification | Σ | 0..* | CodeableConcept | Allows the product to be classified by various systems Binding: WHO ATC (preferred) | ||||
| marketingStatus | Σ | 0..* | MarketingStatus | Marketing status of the medicinal product in contrast to marketing authorization | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| country | Σ | 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 | ||||
| jurisdiction | Σ | 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 | ||||
| status | Σ | 1..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 Binding: Marketing Status (preferred) | ||||
| dateRange | Σ | 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 | ||||
| restoreDate | Σ | 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 | ||||
| packagedMedicinalProduct | Σ | 0..* | CodeableConcept | High level package type for this product. E.g., sample pack Binding: High level Pack Type (preferred) | ||||
| comprisedOf | Σ | 0..* | Reference(ManufacturedItemDefinition | DeviceDefinition) | Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes | ||||
| ingredient | Σ | 0..* | CodeableConcept | The ingredients of this medicinal product - when not detailed in other resources Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
| impurity | Σ | 0..* | CodeableReference(SubstanceDefinition) | Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
| attachedDocument | Σ | 0..* | Reference(DocumentReference) | Additional documentation about the medicinal product | ||||
| masterFile | Σ | 0..* | Reference(DocumentReference) | A master file for the medicinal product (e.g. Pharmacovigilance System Master File) | ||||
| contact | Σ | 0..* | BackboneElement | A product specific contact, person (in a role), or an organization | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type | Σ | 0..1 | CodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. | ||||
| contact | Σ | 1..1 | Reference(Organization | PractitionerRole) | A product specific contact, person (in a role), or an organization | ||||
| clinicalTrial | Σ | 0..* | Reference(ResearchStudy) | Clinical trials or studies that this product is involved in | ||||
| code | Σ | 0..* | Coding | A code that this product is known by, within some formal terminology Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication. | ||||
| name | Σ | 1..* | BackboneElement | The product's name, including full name and possibly coded parts | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| productName | Σ | 1..1 | string | The full name of this product Example general: Humalog Mix50 Insulin KwikPen, 3 ml pre-fill | ||||
| type | Σ | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product. Required Pattern: At least the following | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000001 | |||||
| display | 0..1 | string | Representation defined by the system | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | 0..1 | string | Plain text representation of the concept | |||||
| Slices for part | Σ | 0..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by pattern:type | ||||
| part:All Slices | Content/Rules for all slices | |||||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| part | Σ | 1..1 | string | A fragment of a product name | ||||
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. | ||||
| part:ProprietaryNamePart | Σ | 0..* | BackboneElement | Coding words or phrases of the name | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| part | Σ | 1..1 | string | brand name of this product Example Example brand name: Humalog Mix50 | ||||
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000002 | |||||
| display | 0..1 | string | Representation defined by the system | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | 0..1 | string | Plain text representation of the concept | |||||
| part:Non-proprietaryNamePart | Σ | 0..* | BackboneElement | Coding words or phrases of the name | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| part | Σ | 1..1 | string | International Non-proprietary Name (INN) of this product Example Example INN: Insulin lispro | ||||
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000003 | |||||
| display | 0..1 | string | Representation defined by the system | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | 0..1 | string | Plain text representation of the concept | |||||
| part:StrengthPart | Σ | 0..* | BackboneElement | Coding words or phrases of the name | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| part | Σ | 1..1 | string | strength expressed as the quantity of active ingredient Example Example quantity: 100 units/ml | ||||
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000004 | |||||
| display | 0..1 | string | Representation defined by the system | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | 0..1 | string | Plain text representation of the concept | |||||
| part:PharmaceuticalDoseFormPart | Σ | 0..* | BackboneElement | Coding words or phrases of the name | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| part | Σ | 1..1 | string | Physical manifestation of a product as intended to be delivered to the patient. Example Example dose form: solution for injection | ||||
| type | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| coding | 1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| system | 1..1 | uri | Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/rmswi/220000000000 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 220000000005 | |||||
| display | 0..1 | string | Representation defined by the system | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | 0..1 | string | Plain text representation of the concept | |||||
| usage | Σ | 0..* | BackboneElement | Country and jurisdiction where the name applies | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| country | Σ | 1..1 | CodeableConcept | Country code for where this name applies Binding: ISO Country two letter code (preferred) | ||||
| jurisdiction | Σ | 0..1 | CodeableConcept | Jurisdiction code for where this name applies Binding: ISO Country two letter code (preferred) | ||||
| language | Σ | 1..1 | CodeableConcept | Language code for this name Binding: CommonLanguages (preferred): IETF language tag
| ||||
| crossReference | Σ | 0..* | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| product | Σ | 1..1 | CodeableReference(MedicinalProductDefinition) | Reference to another product, e.g. for linking authorised to investigational product | ||||
| type | Σ | 0..1 | CodeableConcept | The type of relationship, for instance branded to generic or virtual to actual product Binding: ProductCrossReferenceType (extensible) | ||||
| operation | Σ | 0..* | BackboneElement | A manufacturing or administrative process for the medicinal product | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type | Σ | 0..1 | CodeableReference(ActivityDefinition | PlanDefinition) | The type of manufacturing operation e.g. manufacturing itself, re-packaging Binding: Type of operation (preferred) | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| concept | Σ | 1..1 | CodeableConcept | Reference to a concept (by class) | ||||
| reference | Σ | 0..1 | Reference() | Reference to a resource (by instance) | ||||
| effectiveDate | Σ | 0..1 | Period | Date range of applicability | ||||
| organization | Σ | 0..* | Reference(Organization (ePI)) | The organization responsible for the particular process, e.g. the manufacturer or importer | ||||
| confidentialityIndicator | Σ | 0..1 | CodeableConcept | Specifies whether this process is considered proprietary or confidential Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product. | ||||
| characteristic | Σ | 0..* | BackboneElement | Key product features such as "sugar free", "modified release" | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type | Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
| value[x] | Σ | 0..1 | A value for the characteristic | |||||
| valueCodeableConcept | CodeableConcept | |||||||
| valueString | string | |||||||
| valueQuantity | Quantity | |||||||
| valueInteger | integer | |||||||
| valueDate | date | |||||||
| valueBoolean | boolean | |||||||
| valueAttachment | Attachment | |||||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | ||||
| MedicinalProductDefinition.language | preferred | CommonLanguages
| ||||
| MedicinalProductDefinition.identifier.use | required | IdentifierUse | ||||
| MedicinalProductDefinition.identifier.type | extensible | Identifier Type Codes | ||||
| MedicinalProductDefinition.identifier.system | extensible | VsMedProductIdSystems | ||||
| MedicinalProductDefinition.type | preferred | VsMedProductType (a valid code from https://spor.ema.europa.eu/rmswi/200000025915) | ||||
| MedicinalProductDefinition.domain | preferred | MedicinalProductDomain | ||||
| MedicinalProductDefinition.status | preferred | PublicationStatus | ||||
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | preferred | VsPharmaceuticalDoseForm (a valid code from https://spor.ema.europa.eu/rmswi/200000000006) | ||||
| MedicinalProductDefinition.route | preferred | VsRouteOfAdministration (a valid code from https://spor.ema.europa.eu/rmswi/100000073345) | ||||
| MedicinalProductDefinition.legalStatusOfSupply | preferred | VsLegalStatusOfSupply (a valid code from https://spor.ema.europa.eu/rmswi/100000072051) | ||||
| MedicinalProductDefinition.additionalMonitoringIndicator | preferred | VsAdditionalMonitoringIndicator (a valid code from http://example.org) | ||||
| MedicinalProductDefinition.specialMeasures | example | SpecialMeasures | ||||
| MedicinalProductDefinition.pediatricUseIndicator | preferred | VsPediatricUseIndicator (a valid code from http://example.org) | ||||
| MedicinalProductDefinition.classification | preferred | VsAtcClassification | ||||
| MedicinalProductDefinition.marketingStatus.status | preferred | VsMarketingStatus (a valid code from https://spor.ema.europa.eu/rmswi/100000072052) | ||||
| MedicinalProductDefinition.packagedMedicinalProduct | preferred | VsPackageType | ||||
| MedicinalProductDefinition.ingredient | example | SNOMEDCTSubstanceCodes | ||||
| MedicinalProductDefinition.impurity | example | SNOMEDCTSubstanceCodes | ||||
| MedicinalProductDefinition.contact.type | example | ProductContactType | ||||
| MedicinalProductDefinition.code | example | SNOMEDCTMedicationCodes | ||||
| MedicinalProductDefinition.name.type | example | Pattern: 220000000001 | ||||
| MedicinalProductDefinition.name.part.type | example | ProductNamePartType | ||||
| MedicinalProductDefinition.name.part:ProprietaryNamePart.type | example | Pattern: 220000000002 | ||||
| MedicinalProductDefinition.name.part:Non-proprietaryNamePart.type | example | Pattern: 220000000003 | ||||
| MedicinalProductDefinition.name.part:StrengthPart.type | example | Pattern: 220000000004 | ||||
| MedicinalProductDefinition.name.part:PharmaceuticalDoseFormPart.type | example | Pattern: 220000000005 | ||||
| MedicinalProductDefinition.name.usage.country | preferred | VsCountry | ||||
| MedicinalProductDefinition.name.usage.jurisdiction | preferred | VsCountry | ||||
| MedicinalProductDefinition.name.usage.language | preferred | CommonLanguages
| ||||
| MedicinalProductDefinition.crossReference.type | extensible | ProductCrossReferenceType | ||||
| MedicinalProductDefinition.operation.type | preferred | VsOperationType (a valid code from http://example.org) | ||||
| MedicinalProductDefinition.operation.confidentialityIndicator | example | ProductConfidentiality | ||||
| MedicinalProductDefinition.characteristic.type | example | ProductCharacteristic |
This structure is derived from MedicinalProductDefinition
Summary
Mandatory: 3 elements (1 nested mandatory element)
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Other representations of profile: CSV, Excel, Schematron
IG © 2021+ . Package hl7.fhir.uv.emedicinal-product-info#1.0.0-ballot based on FHIR 5.0.0-ballot. Generated 2022-12-04
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change