Profile: Medicinal Product
The Medicinal Product resource represents medicinal products authorised to be marketed in Norway.
| name | type | status | url |
|---|---|---|---|
| MedicinalProductHresept | MedicinalProduct | draft | https://simplifier.net/h-resept/StructureDefinition/MedicinalProductHresept |
The Medicinal Product FHIR Information Model
The Medicinal Product FHIR Profile Structure
| MedicinalProductHresept (MedicinalProduct) | C | MedicinalProduct | |
| id | Σ | 0..1 | string |
| meta | Σ | 0..1 | Meta |
| implicitRules | Σ ?! | 0..1 | uri |
| language | 0..1 | codeBinding | |
| text | 0..1 | Narrative | |
| contained | 0..* | Resource | |
| extension | C | 0..0 | Extension |
| modifierExtension | ?! C | 0..0 | Extension |
| identifier | Σ | 0..* | Identifier |
| HreseptMedicinalProductId | Σ | 1..1 | Identifier |
| id | 0..1 | string | |
| extension | C | 0..0 | Extension |
| use | Σ ?! | 0..0 | codeBinding |
| type | Σ | 0..0 | CodeableConceptBinding |
| system | Σ | 0..1 | uri |
| value | Σ | 0..1 | string |
| period | Σ C | 0..1 | Period |
| assigner | Σ C | 0..0 | Reference(Organization) |
| legemiddelmerkevareId | Σ | 0..1 | Identifier |
| id | 0..1 | string | |
| extension | C | 0..0 | Extension |
| use | Σ ?! | 0..0 | codeBinding |
| type | Σ | 0..0 | CodeableConceptBinding |
| system | Σ | 0..1 | uri |
| value | Σ | 0..1 | string |
| period | Σ C | 0..1 | Period |
| assigner | Σ C | 0..0 | Reference(Organization) |
| type | Σ | 0..0 | CodeableConcept |
| domain | Σ | 0..0 | Coding |
| combinedPharmaceuticalDoseForm | Σ | 0..0 | CodeableConcept |
| legalStatusOfSupply | Σ | 0..0 | CodeableConcept |
| additionalMonitoringIndicator | Σ | 0..0 | CodeableConcept |
| specialMeasures | Σ | 0..0 | string |
| paediatricUseIndicator | Σ | 0..0 | CodeableConcept |
| productClassification | Σ | 0..0 | CodeableConcept |
| marketingStatus | Σ | 0..0 | MarketingStatus |
| pharmaceuticalProduct | Σ C | 0..0 | Reference(MedicinalProductPharmaceutical) |
| packagedMedicinalProduct | Σ C | 1..* | Reference(MedicinalProductPackaged) |
| attachedDocument | Σ C | 0..0 | Reference(DocumentReference) |
| masterFile | Σ C | 0..0 | Reference(DocumentReference) |
| contact | Σ C | 0..0 | Reference(Organization | PractitionerRole) |
| clinicalTrial | Σ C | 0..0 | Reference(ResearchStudy) |
| name | Σ | 1..* | BackboneElement |
| id | 0..1 | string | |
| extension | C | 0..0 | Extension |
| modifierExtension | Σ ?! C | 0..0 | Extension |
| productName | Σ | 1..1 | string |
| namePart | Σ | 0..0 | BackboneElement |
| countryLanguage | Σ | 0..0 | BackboneElement |
| crossReference | Σ | 0..0 | Identifier |
| manufacturingBusinessOperation | Σ | 0..0 | BackboneElement |
| specialDesignation | Σ | 0..0 | BackboneElement |
| MedicinalProduct | |||
| Short | Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use) | ||
| Definition | Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use). | ||
| Cardinality | 0..* | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.id | |||
| Short | Logical id of this artifact | ||
| Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. | ||
| Cardinality | 0..1 | ||
| Type | string | ||
| Summary | True | ||
| Comments | The only time that a resource does not have an id is when it is being submitted to the server using a create operation. | ||
| MedicinalProduct.meta | |||
| Short | Metadata about the resource | ||
| Definition | The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. | ||
| Cardinality | 0..1 | ||
| Type | Meta | ||
| Summary | True | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.implicitRules | |||
| Short | A set of rules under which this content was created | ||
| Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. | ||
| Cardinality | 0..1 | ||
| Type | uri | ||
| Modifier | True | ||
| Summary | True | ||
| Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.language | |||
| Short | Language of the resource content | ||
| Definition | The base language in which the resource is written. | ||
| Cardinality | 0..1 | ||
| Type | code | ||
| Binding | A human language.
| ||
| Comments | Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.text | |||
| Short | Text summary of the resource, for human interpretation | ||
| Definition | A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. | ||
| Cardinality | 0..1 | ||
| Type | Narrative | ||
| Alias | narrative, html, xhtml, display | ||
| Comments | Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.contained | |||
| Short | Contained, inline Resources | ||
| Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. | ||
| Cardinality | 0..* | ||
| Type | Resource | ||
| Alias | inline resources, anonymous resources, contained resources | ||
| Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. | ||
| Mappings |
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| MedicinalProduct.extension | |||
| Short | Additional content defined by implementations | ||
| Definition | May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||
| Cardinality | 0..0 | ||
| Type | Extension | ||
| Alias | extensions, user content | ||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||
| Slicing | Unordered, Open, by url(Value) Extensions are always sliced by (at least) url | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.modifierExtension | |||
| Short | Extensions that cannot be ignored | ||
| Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | ||
| Cardinality | 0..0 | ||
| Type | Extension | ||
| Modifier | True | ||
| Alias | extensions, user content | ||
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. | ||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||
| Slicing | Unordered, Open, by url(Value) Extensions are always sliced by (at least) url | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.identifier | |||
| Short | Business identifier for this product. Could be an MPID | ||
| Definition | Business identifier for this product. Could be an MPID. | ||
| Cardinality | 0..* | ||
| Type | Identifier | ||
| Summary | True | ||
| Alias | MPID | ||
| Slicing | Unordered, Closed, by Sliced | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.identifier:HreseptMedicinalProductId | |||
| Short | Equal to the element's ID | ||
| Definition | Equal to the element's ID, specific to NoMA's FHIR API for H-resept\r\nUrl (preliminary): http://legemiddelverket.no/fhir/Hresept/HreseptMedicinalProductId | ||
| Cardinality | 1..1 | ||
| Type | Identifier | ||
| Summary | True | ||
| Alias | MPID | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.identifier:HreseptMedicinalProductId.id | |||
| Short | Unique id for inter-element referencing | ||
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||
| Cardinality | 0..1 | ||
| Type | string | ||
| Mappings |
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| MedicinalProduct.identifier:HreseptMedicinalProductId.extension | |||
| Short | Additional content defined by implementations | ||
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||
| Cardinality | 0..0 | ||
| Type | Extension | ||
| Alias | extensions, user content | ||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||
| Slicing | Unordered, Open, by url(Value) Extensions are always sliced by (at least) url | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.identifier:HreseptMedicinalProductId.use | |||
| Short | usual | official | temp | secondary | old (If known) | ||
| Definition | The purpose of this identifier. | ||
| Cardinality | 0..0 | ||
| Type | code | ||
| Binding | Identifies the purpose for this identifier, if known . | ||
| Modifier | True | ||
| Summary | True | ||
| Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. | ||
| Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.identifier:HreseptMedicinalProductId.type | |||
| Short | Description of identifier | ||
| Definition | A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. | ||
| Cardinality | 0..0 | ||
| Type | CodeableConcept | ||
| Binding | A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | ||
| Summary | True | ||
| Requirements | Allows users to make use of identifiers when the identifier system is not known. | ||
| Comments | This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.identifier:HreseptMedicinalProductId.system | |||
| Short | The namespace for the identifier value | ||
| Definition | Establishes the namespace for the value - that is, a URL that describes a set values that are unique. | ||
| Cardinality | 0..1 | ||
| Type | uri | ||
| Summary | True | ||
| Requirements | There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. | ||
| Comments | Identifier.system is always case sensitive. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Examples | Generalhttp://www.acme.com/identifiers/patient | ||
| Mappings |
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| MedicinalProduct.identifier:HreseptMedicinalProductId.value | |||
| Short | The value that is unique | ||
| Definition | The portion of the identifier typically relevant to the user and which is unique within the context of the system. | ||
| Cardinality | 0..1 | ||
| Type | string | ||
| Summary | True | ||
| Comments | If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Examples | General123456 | ||
| Mappings |
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| MedicinalProduct.identifier:HreseptMedicinalProductId.period | |||
| Short | Time period when id is/was valid for use | ||
| Definition | Time period during which identifier is/was valid for use. | ||
| Cardinality | 0..1 | ||
| Type | Period | ||
| Summary | True | ||
| Comments | A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). Period is not used for a duration (a measure of elapsed time). See Duration. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.identifier:HreseptMedicinalProductId.assigner | |||
| Short | Organization that issued id (may be just text) | ||
| Definition | Organization that issued/manages the identifier. | ||
| Cardinality | 0..0 | ||
| Type | Reference(Organization) | ||
| Summary | True | ||
| Comments | The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.identifier: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\nUrl (preliminary): http://legemiddelverket.no/FEST/LegemiddelMerkevareID\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. | ||
| Cardinality | 0..1 | ||
| Type | Identifier | ||
| Summary | True | ||
| Alias | MPID | ||
| Meaning when missing | 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. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.identifier:legemiddelmerkevareId.id | |||
| Short | Unique id for inter-element referencing | ||
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||
| Cardinality | 0..1 | ||
| Type | string | ||
| Mappings |
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| MedicinalProduct.identifier:legemiddelmerkevareId.extension | |||
| Short | Additional content defined by implementations | ||
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||
| Cardinality | 0..0 | ||
| Type | Extension | ||
| Alias | extensions, user content | ||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||
| Slicing | Unordered, Open, by url(Value) Extensions are always sliced by (at least) url | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.identifier:legemiddelmerkevareId.use | |||
| Short | usual | official | temp | secondary | old (If known) | ||
| Definition | The purpose of this identifier. | ||
| Cardinality | 0..0 | ||
| Type | code | ||
| Binding | Identifies the purpose for this identifier, if known . | ||
| Modifier | True | ||
| Summary | True | ||
| Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. | ||
| Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.identifier:legemiddelmerkevareId.type | |||
| Short | Description of identifier | ||
| Definition | A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. | ||
| Cardinality | 0..0 | ||
| Type | CodeableConcept | ||
| Binding | A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | ||
| Summary | True | ||
| Requirements | Allows users to make use of identifiers when the identifier system is not known. | ||
| Comments | This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.identifier:legemiddelmerkevareId.system | |||
| Short | The namespace for the identifier value | ||
| Definition | Establishes the namespace for the value - that is, a URL that describes a set values that are unique. | ||
| Cardinality | 0..1 | ||
| Type | uri | ||
| Summary | True | ||
| Requirements | There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. | ||
| Comments | Identifier.system is always case sensitive. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Examples | Generalhttp://www.acme.com/identifiers/patient | ||
| Mappings |
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| MedicinalProduct.identifier:legemiddelmerkevareId.value | |||
| Short | The value that is unique | ||
| Definition | The portion of the identifier typically relevant to the user and which is unique within the context of the system. | ||
| Cardinality | 0..1 | ||
| Type | string | ||
| Summary | True | ||
| Comments | If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Examples | General123456 | ||
| Mappings |
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| MedicinalProduct.identifier:legemiddelmerkevareId.period | |||
| Short | Time period when id is/was valid for use | ||
| Definition | Time period during which identifier is/was valid for use. | ||
| Cardinality | 0..1 | ||
| Type | Period | ||
| Summary | True | ||
| Comments | A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). Period is not used for a duration (a measure of elapsed time). See Duration. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.identifier:legemiddelmerkevareId.assigner | |||
| Short | Organization that issued id (may be just text) | ||
| Definition | Organization that issued/manages the identifier. | ||
| Cardinality | 0..0 | ||
| Type | Reference(Organization) | ||
| Summary | True | ||
| Comments | The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.type | |||
| Short | Regulatory type, e.g. Investigational or Authorized | ||
| Definition | Regulatory type, e.g. Investigational or Authorized. | ||
| Cardinality | 0..0 | ||
| Type | CodeableConcept | ||
| Summary | True | ||
| Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.domain | |||
| Short | If this medicine applies to human or veterinary uses | ||
| Definition | If this medicine applies to human or veterinary uses. | ||
| Cardinality | 0..0 | ||
| Type | Coding | ||
| Summary | True | ||
| Comments | Codes may be defined very casually in enumerations or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.combinedPharmaceuticalDoseForm | |||
| Short | The dose form for a single part product, or combined form of a multiple part product | ||
| Definition | The dose form for a single part product, or combined form of a multiple part product. | ||
| Cardinality | 0..0 | ||
| Type | CodeableConcept | ||
| Summary | True | ||
| Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.legalStatusOfSupply | |||
| Short | The legal status of supply of the medicinal product as classified by the regulator | ||
| Definition | The legal status of supply of the medicinal product as classified by the regulator. | ||
| Cardinality | 0..0 | ||
| Type | CodeableConcept | ||
| Summary | True | ||
| Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.additionalMonitoringIndicator | |||
| Short | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons | ||
| Definition | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons. | ||
| Cardinality | 0..0 | ||
| Type | CodeableConcept | ||
| Summary | True | ||
| Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.specialMeasures | |||
| Short | Whether the Medicinal Product is subject to special measures for regulatory reasons | ||
| Definition | Whether the Medicinal Product is subject to special measures for regulatory reasons. | ||
| Cardinality | 0..0 | ||
| Type | string | ||
| Summary | True | ||
| Comments | Note that FHIR strings SHALL NOT exceed 1MB in size | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
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| Mappings |
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| MedicinalProduct.paediatricUseIndicator | |||
| Short | If authorised for use in children | ||
| Definition | If authorised for use in children. | ||
| Cardinality | 0..0 | ||
| Type | CodeableConcept | ||
| Summary | True | ||
| Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.productClassification | |||
| Short | Allows the product to be classified by various systems | ||
| Definition | Allows the product to be classified by various systems. | ||
| Cardinality | 0..0 | ||
| Type | CodeableConcept | ||
| Summary | True | ||
| Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.marketingStatus | |||
| Short | Marketing status of the medicinal product, in contrast to marketing authorizaton | ||
| Definition | Marketing status of the medicinal product, in contrast to marketing authorizaton. | ||
| Cardinality | 0..0 | ||
| Type | MarketingStatus | ||
| Summary | True | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.pharmaceuticalProduct | |||
| Short | Pharmaceutical aspects of product | ||
| Definition | Pharmaceutical aspects of product. | ||
| Cardinality | 0..0 | ||
| Type | Reference(MedicinalProductPharmaceutical) | ||
| Summary | True | ||
| Comments | References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.packagedMedicinalProduct | |||
| Short | Package representation for the product | ||
| Definition | Package representation for the product. | ||
| Cardinality | 1..* | ||
| Type | Reference(MedicinalProductPackaged) | ||
| Summary | True | ||
| Comments | References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.attachedDocument | |||
| Short | Supporting documentation, typically for regulatory submission | ||
| Definition | Supporting documentation, typically for regulatory submission. | ||
| Cardinality | 0..0 | ||
| Type | Reference(DocumentReference) | ||
| Summary | True | ||
| Comments | References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.masterFile | |||
| Short | A master file for to the medicinal product (e.g. Pharmacovigilance System Master File) | ||
| Definition | A master file for to the medicinal product (e.g. Pharmacovigilance System Master File). | ||
| Cardinality | 0..0 | ||
| Type | Reference(DocumentReference) | ||
| Summary | True | ||
| Comments | References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.contact | |||
| Short | A product specific contact, person (in a role), or an organization | ||
| Definition | A product specific contact, person (in a role), or an organization. | ||
| Cardinality | 0..0 | ||
| Type | Reference(Organization | PractitionerRole) | ||
| Summary | True | ||
| Comments | References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.clinicalTrial | |||
| Short | Clinical trials or studies that this product is involved in | ||
| Definition | Clinical trials or studies that this product is involved in. | ||
| Cardinality | 0..0 | ||
| Type | Reference(ResearchStudy) | ||
| Summary | True | ||
| Comments | References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.name | |||
| Short | The product's name | ||
| Definition | The product's name. Only includes full name, which for now only consists of the "invented name" part. | ||
| Cardinality | 1..* | ||
| Type | BackboneElement | ||
| Summary | True | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.name.id | |||
| Short | Unique id for inter-element referencing | ||
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||
| Cardinality | 0..1 | ||
| Type | string | ||
| Mappings |
| ||
| MedicinalProduct.name.extension | |||
| Short | Additional content defined by implementations | ||
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||
| Cardinality | 0..0 | ||
| Type | Extension | ||
| Alias | extensions, user content | ||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||
| Slicing | Unordered, Open, by url(Value) Extensions are always sliced by (at least) url | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.name.modifierExtension | |||
| Short | Extensions that cannot be ignored even if unrecognized | ||
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | ||
| Cardinality | 0..0 | ||
| Type | Extension | ||
| Modifier | True | ||
| Summary | True | ||
| Alias | extensions, user content, modifiers | ||
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. | ||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.name.productName | |||
| Short | The full product name | ||
| Definition | The full product name. | ||
| Cardinality | 1..1 | ||
| Type | string | ||
| Summary | True | ||
| Comments | Note that FHIR strings SHALL NOT exceed 1MB in size | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.name.namePart | |||
| Short | Coding words or phrases of the name | ||
| Definition | Coding words or phrases of the name. | ||
| Cardinality | 0..0 | ||
| Type | BackboneElement | ||
| Summary | True | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.name.namePart.id | |||
| Short | Unique id for inter-element referencing | ||
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||
| Cardinality | 0..1 | ||
| Type | string | ||
| Mappings |
| ||
| MedicinalProduct.name.namePart.extension | |||
| Short | Additional content defined by implementations | ||
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||
| Cardinality | 0..* | ||
| Type | Extension | ||
| Alias | extensions, user content | ||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||
| Slicing | Unordered, Open, by url(Value) Extensions are always sliced by (at least) url | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.name.namePart.modifierExtension | |||
| Short | Extensions that cannot be ignored even if unrecognized | ||
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | ||
| Cardinality | 0..* | ||
| Type | Extension | ||
| Modifier | True | ||
| Summary | True | ||
| Alias | extensions, user content, modifiers | ||
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. | ||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.name.namePart.part | |||
| Short | A fragment of a product name | ||
| Definition | A fragment of a product name. | ||
| Cardinality | 1..1 | ||
| Type | string | ||
| Summary | True | ||
| Comments | Note that FHIR strings SHALL NOT exceed 1MB in size | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.name.namePart.type | |||
| Short | Idenifying type for this part of the name (e.g. strength part) | ||
| Definition | Idenifying type for this part of the name (e.g. strength part). | ||
| Cardinality | 1..1 | ||
| Type | Coding | ||
| Summary | True | ||
| Comments | Codes may be defined very casually in enumerations or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.name.countryLanguage | |||
| Short | Country where the name applies | ||
| Definition | Country where the name applies. | ||
| Cardinality | 0..0 | ||
| Type | BackboneElement | ||
| Summary | True | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.name.countryLanguage.id | |||
| Short | Unique id for inter-element referencing | ||
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||
| Cardinality | 0..1 | ||
| Type | string | ||
| Mappings |
| ||
| MedicinalProduct.name.countryLanguage.extension | |||
| Short | Additional content defined by implementations | ||
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||
| Cardinality | 0..* | ||
| Type | Extension | ||
| Alias | extensions, user content | ||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||
| Slicing | Unordered, Open, by url(Value) Extensions are always sliced by (at least) url | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.name.countryLanguage.modifierExtension | |||
| Short | Extensions that cannot be ignored even if unrecognized | ||
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | ||
| Cardinality | 0..* | ||
| Type | Extension | ||
| Modifier | True | ||
| Summary | True | ||
| Alias | extensions, user content, modifiers | ||
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. | ||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.name.countryLanguage.country | |||
| Short | Country code for where this name applies | ||
| Definition | Country code for where this name applies. | ||
| Cardinality | 1..1 | ||
| Type | CodeableConcept | ||
| Summary | True | ||
| Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.name.countryLanguage.jurisdiction | |||
| Short | Jurisdiction code for where this name applies | ||
| Definition | Jurisdiction code for where this name applies. | ||
| Cardinality | 0..1 | ||
| Type | CodeableConcept | ||
| Summary | True | ||
| Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.name.countryLanguage.language | |||
| Short | Language code for this name | ||
| Definition | Language code for this name. | ||
| Cardinality | 1..1 | ||
| Type | CodeableConcept | ||
| Summary | True | ||
| Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.crossReference | |||
| Short | Reference to another product, e.g. for linking authorised to investigational product | ||
| Definition | Reference to another product, e.g. for linking authorised to investigational product. | ||
| Cardinality | 0..0 | ||
| Type | Identifier | ||
| Summary | True | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.manufacturingBusinessOperation | |||
| Short | An operation applied to the product, for manufacturing or adminsitrative purpose | ||
| Definition | An operation applied to the product, for manufacturing or adminsitrative purpose. | ||
| Cardinality | 0..0 | ||
| Type | BackboneElement | ||
| Summary | True | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.manufacturingBusinessOperation.id | |||
| Short | Unique id for inter-element referencing | ||
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||
| Cardinality | 0..1 | ||
| Type | string | ||
| Mappings |
| ||
| MedicinalProduct.manufacturingBusinessOperation.extension | |||
| Short | Additional content defined by implementations | ||
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||
| Cardinality | 0..* | ||
| Type | Extension | ||
| Alias | extensions, user content | ||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||
| Slicing | Unordered, Open, by url(Value) Extensions are always sliced by (at least) url | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.manufacturingBusinessOperation.modifierExtension | |||
| Short | Extensions that cannot be ignored even if unrecognized | ||
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | ||
| Cardinality | 0..* | ||
| Type | Extension | ||
| Modifier | True | ||
| Summary | True | ||
| Alias | extensions, user content, modifiers | ||
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. | ||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.manufacturingBusinessOperation.operationType | |||
| Short | The type of manufacturing operation | ||
| Definition | The type of manufacturing operation. | ||
| Cardinality | 0..1 | ||
| Type | CodeableConcept | ||
| Summary | True | ||
| Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber | |||
| Short | Regulatory authorization reference number | ||
| Definition | Regulatory authorization reference number. | ||
| Cardinality | 0..1 | ||
| Type | Identifier | ||
| Summary | True | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.manufacturingBusinessOperation.effectiveDate | |||
| Short | Regulatory authorization date | ||
| Definition | Regulatory authorization date. | ||
| Cardinality | 0..1 | ||
| Type | dateTime | ||
| Summary | True | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator | |||
| Short | To indicate if this proces is commercially confidential | ||
| Definition | To indicate if this proces is commercially confidential. | ||
| Cardinality | 0..1 | ||
| Type | CodeableConcept | ||
| Summary | True | ||
| Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.manufacturingBusinessOperation.manufacturer | |||
| Short | The manufacturer or establishment associated with the process | ||
| Definition | The manufacturer or establishment associated with the process. | ||
| Cardinality | 0..* | ||
| Type | Reference(Organization) | ||
| Summary | True | ||
| Comments | References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.manufacturingBusinessOperation.regulator | |||
| Short | A regulator which oversees the operation | ||
| Definition | A regulator which oversees the operation. | ||
| Cardinality | 0..1 | ||
| Type | Reference(Organization) | ||
| Summary | True | ||
| Comments | References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.specialDesignation | |||
| Short | Indicates if the medicinal product has an orphan designation for the treatment of a rare disease | ||
| Definition | Indicates if the medicinal product has an orphan designation for the treatment of a rare disease. | ||
| Cardinality | 0..0 | ||
| Type | BackboneElement | ||
| Summary | True | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.specialDesignation.id | |||
| Short | Unique id for inter-element referencing | ||
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||
| Cardinality | 0..1 | ||
| Type | string | ||
| Mappings |
| ||
| MedicinalProduct.specialDesignation.extension | |||
| Short | Additional content defined by implementations | ||
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||
| Cardinality | 0..* | ||
| Type | Extension | ||
| Alias | extensions, user content | ||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||
| Slicing | Unordered, Open, by url(Value) Extensions are always sliced by (at least) url | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
| Constraints |
| ||
| Mappings |
| ||
| MedicinalProduct.specialDesignation.modifierExtension | |||
| Short | Extensions that cannot be ignored even if unrecognized | ||
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | ||
| Cardinality | 0..* | ||
| Type | Extension | ||
| Modifier | True | ||
| Summary | True | ||
| Alias | extensions, user content, modifiers | ||
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. | ||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
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| MedicinalProduct.specialDesignation.identifier | |||
| Short | Identifier for the designation, or procedure number | ||
| Definition | Identifier for the designation, or procedure number. | ||
| Cardinality | 0..* | ||
| Type | Identifier | ||
| Summary | True | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
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| MedicinalProduct.specialDesignation.type | |||
| Short | The type of special designation, e.g. orphan drug, minor use | ||
| Definition | The type of special designation, e.g. orphan drug, minor use. | ||
| Cardinality | 0..1 | ||
| Type | CodeableConcept | ||
| Summary | True | ||
| Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
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| MedicinalProduct.specialDesignation.intendedUse | |||
| Short | The intended use of the product, e.g. prevention, treatment | ||
| Definition | The intended use of the product, e.g. prevention, treatment. | ||
| Cardinality | 0..1 | ||
| Type | CodeableConcept | ||
| Summary | True | ||
| Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
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| MedicinalProduct.specialDesignation.indication[x] | |||
| Short | Condition for which the medicinal use applies | ||
| Definition | Condition for which the medicinal use applies. | ||
| Cardinality | 0..1 | ||
| Type | CodeableConcept | Reference(MedicinalProductIndication) | ||
| Summary | True | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
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| MedicinalProduct.specialDesignation.status | |||
| Short | For example granted, pending, expired or withdrawn | ||
| Definition | For example granted, pending, expired or withdrawn. | ||
| Cardinality | 0..1 | ||
| Type | CodeableConcept | ||
| Summary | True | ||
| Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
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| MedicinalProduct.specialDesignation.date | |||
| Short | Date when the designation was granted | ||
| Definition | Date when the designation was granted. | ||
| Cardinality | 0..1 | ||
| Type | dateTime | ||
| Summary | True | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
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| MedicinalProduct.specialDesignation.species | |||
| Short | Animal species for which this applies | ||
| Definition | Animal species for which this applies. | ||
| Cardinality | 0..1 | ||
| Type | CodeableConcept | ||
| Summary | True | ||
| Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. | ||
| Conditions | The cardinality or value of this element may be affected by these constraints: ele-1 | ||
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