Prototype ISO IDMP Compliant Datafeed to eHealth (Deliverable D4.12)
1.0.0 - STU1
Prototype ISO IDMP Compliant Datafeed to eHealth (Deliverable D4.12), published by UNICOM. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/unicom-project-eu/d4.12/ and changes regularly. See the Directory of published versions
Draft as of 2024-08-20 |
Definitions for the MedicinalProductD412 resource profile.
Guidance on how to interpret the contents of this table can be found here
0. MedicinalProductDefinition | |
2. MedicinalProductDefinition.identifier | |
Definition | EMA IG 1.2 & 1.3. Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other. Not to be used for package or pharmaceutical product identifiers. |
Short | Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other |
Note | This is a business identifier, not a resource identifier (see discussion) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.identifier . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
4. MedicinalProductDefinition.identifier:mpid | |
Slice Name | mpid |
Definition | EMA IG 1.2. MPID if exists. For UNICOM testing data fake MPIDs are used (Country code + MAH LocID + unique code). |
Short | MPID |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1 |
6. MedicinalProductDefinition.identifier:mpid.system | |
Control | 1..? |
Pattern Value | http://ema.europa.eu/fhir/mpId |
8. MedicinalProductDefinition.identifier:pmsid | |
Slice Name | pmsid |
Definition | EMA IG 1.1. EMA Product Management System identifier if exists. For UNICOM testing data fake PMS IDs can be used |
Short | PMS ID |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1 |
10. MedicinalProductDefinition.identifier:pmsid.system | |
Control | 1..? |
Pattern Value | http://ema.europa.eu/fhir/pmsId |
12. MedicinalProductDefinition.domain | |
Definition | EMA IG 1.3 |
Binding | The codes SHALL be taken from EMA SPOR Domain (required to http://unicom-project.eu/fhir/d4-12/ValueSet/domain-vs ) |
14. MedicinalProductDefinition.status | |
Short | Status of the product's data. Default 200000005004 'Current' |
16. MedicinalProductDefinition.combinedPharmaceuticalDoseForm | |
Definition | EMA IG 1.5 & 1.6. Authorised dose form for the whole product. As applicable in one of the SPOR RMS list Combined pharmaceutical dose form, Pharmaceutical dose form, Combined term, Combination Package |
Short | Authorised dose form for the product, incl combination package dose forms |
Binding | The codes SHALL be taken from EMA SPOR Authorised Dose Form (required to http://unicom-project.eu/fhir/d4-12/ValueSet/authorised-doseform-vs ) |
18. MedicinalProductDefinition.legalStatusOfSupply | |
Definition | EMA IG 1.7. Legal status of supply on the medicinal product level. The same information can be repeated/differentiated on the package level |
Short | Legal status of supply on the medicinal product level. |
Binding | The codes SHALL be taken from EMA SPOR Legal Status for the Supply (required to http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs ) |
20. MedicinalProductDefinition.classification | |
Definition | EMA IG 1.13 |
Short | ATC or other classification |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.classification . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
22. MedicinalProductDefinition.classification:atc | |
Slice Name | atc |
Control | 0..* |
24. MedicinalProductDefinition.classification:atc.coding | |
Definition | EMA IG 1.13.3 |
Short | ATC classification |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.classification.coding . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
26. MedicinalProductDefinition.classification:atc.coding:ema | |
Slice Name | ema |
Short | ATC classification as EMA SPOR code |
Control | 0..1 |
28. MedicinalProductDefinition.classification:atc.coding:ema.system | |
Control | 1..? |
Pattern Value | https://spor.ema.europa.eu/v1/lists/100000093533 |
30. MedicinalProductDefinition.classification:atc.coding:who | |
Slice Name | who |
Short | ATC classification as WHO ATC code |
Control | 0..1 |
32. MedicinalProductDefinition.classification:atc.coding:who.system | |
Control | 1..? |
Pattern Value | http://www.whocc.no/atc |
34. MedicinalProductDefinition.name | |
Definition | EMA IG 1.14 |
36. MedicinalProductDefinition.name.productName | |
Definition | EMA IG 1.14.1 |
38. MedicinalProductDefinition.name.usage | |
Definition | EMA IG 1.14.2 |
40. MedicinalProductDefinition.name.usage.country | |
42. MedicinalProductDefinition.name.usage.country.coding | |
Short | EMA or ISO codes for country |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.name.usage.country.coding . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
44. MedicinalProductDefinition.name.usage.country.coding:ema | |
Slice Name | ema |
Control | 0..1 |
46. MedicinalProductDefinition.name.usage.country.coding:ema.system | |
Control | 1..? |
Pattern Value | https://spor.ema.europa.eu/v1/lists/100000000002 |
48. MedicinalProductDefinition.name.usage.country.coding:iso | |
Slice Name | iso |
Control | 0..1 |
50. MedicinalProductDefinition.name.usage.country.coding:iso.system | |
Control | 1..? |
Pattern Value | https://www.hl7.org/fhir/valueset-country.html |
52. MedicinalProductDefinition.name.usage.language | |
54. MedicinalProductDefinition.name.usage.language.coding | |
Short | EMA or ISO codes for country |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.name.usage.language.coding . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
56. MedicinalProductDefinition.name.usage.language.coding:ema | |
Slice Name | ema |
Control | 0..1 |
58. MedicinalProductDefinition.name.usage.language.coding:ema.system | |
Control | 1..? |
Pattern Value | https://spor.ema.europa.eu/v1/lists/100000072057 |
60. MedicinalProductDefinition.name.usage.language.coding:bcp | |
Slice Name | bcp |
Control | 0..1 |
62. MedicinalProductDefinition.name.usage.language.coding:bcp.system | |
Control | 1..? |
Pattern Value | http://hl7.org/fhir/ValueSet/all-languages |
Guidance on how to interpret the contents of this table can be found here
0. MedicinalProductDefinition | |
Definition | A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs). |
Short | Detailed definition of a medicinal product |
Control | 0..* |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty()) dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()) dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (text.`div`.exists()) |
2. MedicinalProductDefinition.implicitRules | |
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. |
Short | A set of rules under which this content was created |
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 its narrative along with other profiles, value sets, etc. |
Control | 0..1 |
Type | uri |
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
4. MedicinalProductDefinition.contained | |
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. |
Short | Contained, inline 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. |
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
Type | Resource |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | inline resources, anonymous resources, contained resources |
6. MedicinalProductDefinition.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
Must Support | false |
Summary | true |
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. |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
8. MedicinalProductDefinition.identifier | |
Definition | EMA IG 1.2 & 1.3. Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other. Not to be used for package or pharmaceutical product identifiers. Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code. |
Short | Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or otherBusiness identifier for this product. Could be an MPID |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..* |
Type | Identifier |
Is Modifier | false |
Must Support | false |
Summary | true |
Alternate Names | MPID |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.identifier . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
10. MedicinalProductDefinition.identifier:mpid | |
Slice Name | mpid |
Definition | EMA IG 1.2. MPID if exists. For UNICOM testing data fake MPIDs are used (Country code + MAH LocID + unique code). Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code. |
Short | MPIDBusiness identifier for this product. Could be an MPID |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1* |
Type | Identifier |
Is Modifier | false |
Must Support | false |
Summary | true |
Alternate Names | MPID |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
12. MedicinalProductDefinition.identifier:mpid.use | |
Definition | The purpose of this identifier. |
Short | usual | official | temp | secondary | old (If known) |
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
Control | 0..1 |
Binding | The codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 )Identifies the purpose for this identifier, if known . |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
14. MedicinalProductDefinition.identifier:mpid.system | |
Definition | Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique. |
Short | The namespace for the identifier value |
Comments | Identifier.system is always case sensitive. |
Control | 10..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
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. |
Pattern Value | http://ema.europa.eu/fhir/mpId |
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
16. MedicinalProductDefinition.identifier:pmsid | |
Slice Name | pmsid |
Definition | EMA IG 1.1. EMA Product Management System identifier if exists. For UNICOM testing data fake PMS IDs can be used Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code. |
Short | PMS IDBusiness identifier for this product. Could be an MPID |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1* |
Type | Identifier |
Is Modifier | false |
Must Support | false |
Summary | true |
Alternate Names | MPID |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
18. MedicinalProductDefinition.identifier:pmsid.use | |
Definition | The purpose of this identifier. |
Short | usual | official | temp | secondary | old (If known) |
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
Control | 0..1 |
Binding | The codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 )Identifies the purpose for this identifier, if known . |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
20. MedicinalProductDefinition.identifier:pmsid.system | |
Definition | Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique. |
Short | The namespace for the identifier value |
Comments | Identifier.system is always case sensitive. |
Control | 10..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
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. |
Pattern Value | http://ema.europa.eu/fhir/pmsId |
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
22. MedicinalProductDefinition.domain | |
Definition | EMA IG 1.3 If this medicine applies to human or veterinary uses. |
Short | If this medicine applies to human or veterinary uses |
Control | 0..1 |
Binding | The codes SHALL be taken from For example codes, see EMA SPOR Domainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain (required to http://unicom-project.eu/fhir/d4-12/ValueSet/domain-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
24. MedicinalProductDefinition.status | |
Definition | The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status. |
Short | Status of the product's data. Default 200000005004 'Current'The status within the lifecycle of this product record |
Control | 0..1 |
Binding | The codes SHOULD be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status (preferred to http://hl7.org/fhir/ValueSet/publication-status )The lifecycle status of an artifact. |
Type | CodeableConcept |
Is Modifier | true because This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
26. MedicinalProductDefinition.combinedPharmaceuticalDoseForm | |
Definition | EMA IG 1.5 & 1.6. Authorised dose form for the whole product. As applicable in one of the SPOR RMS list Combined pharmaceutical dose form, Pharmaceutical dose form, Combined term, Combination Package The dose form for a single part product, or combined form of a multiple part product. This is one concept that describes all the components. It does not represent the form with components physically mixed, if that might be necessary, for which see (AdministrableProductDefinition.administrableDoseForm). |
Short | Authorised dose form for the product, incl combination package dose formsThe dose form for a single part product, or combined form of a multiple part product |
Control | 0..1 |
Binding | The codes SHALL be taken from For example codes, see EMA SPOR Authorised Dose Formhttp://hl7.org/fhir/ValueSet/combined-dose-form (required to http://unicom-project.eu/fhir/d4-12/ValueSet/authorised-doseform-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
28. MedicinalProductDefinition.legalStatusOfSupply | |
Definition | EMA IG 1.7. Legal status of supply on the medicinal product level. The same information can be repeated/differentiated on the package level The legal status of supply of the medicinal product as classified by the regulator. |
Short | Legal status of supply on the medicinal product level.The legal status of supply of the medicinal product as classified by the regulator |
Control | 0..1 |
Binding | The codes SHALL be taken from For example codes, see EMA SPOR Legal Status for the Supplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supply (required to http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
30. MedicinalProductDefinition.classification | |
Definition | EMA IG 1.13 Allows the product to be classified by various systems, commonly WHO ATC. |
Short | ATC or other classificationAllows the product to be classified by various systems |
Control | 0..* |
Binding | For example codes, see ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification (example to http://hl7.org/fhir/ValueSet/medicinal-product-classification )This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.classification . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
32. MedicinalProductDefinition.classification:atc | |
Slice Name | atc |
Definition | Allows the product to be classified by various systems, commonly WHO ATC. |
Short | Allows the product to be classified by various systems |
Control | 0..* |
Binding | For example codes, see ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification (example to http://hl7.org/fhir/ValueSet/medicinal-product-classification )This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
34. MedicinalProductDefinition.classification:atc.coding | |
Definition | EMA IG 1.13.3 A reference to a code defined by a terminology system. |
Short | ATC classificationCode defined by a terminology system |
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. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..* |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.classification.coding . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
36. MedicinalProductDefinition.classification:atc.coding:ema | |
Slice Name | ema |
Definition | A reference to a code defined by a terminology system. |
Short | ATC classification as EMA SPOR codeCode defined by a terminology system |
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. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..1* |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
38. MedicinalProductDefinition.classification:atc.coding:ema.system | |
Definition | The identification of the code system that defines the meaning of the symbol in the code. |
Short | Identity of the terminology system |
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously. |
Control | 10..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be unambiguous about the source of the definition of the symbol. |
Pattern Value | https://spor.ema.europa.eu/v1/lists/100000093533 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
40. MedicinalProductDefinition.classification:atc.coding:who | |
Slice Name | who |
Definition | A reference to a code defined by a terminology system. |
Short | ATC classification as WHO ATC codeCode defined by a terminology system |
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. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..1* |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
42. MedicinalProductDefinition.classification:atc.coding:who.system | |
Definition | The identification of the code system that defines the meaning of the symbol in the code. |
Short | Identity of the terminology system |
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously. |
Control | 10..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be unambiguous about the source of the definition of the symbol. |
Pattern Value | http://www.whocc.no/atc |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
44. MedicinalProductDefinition.name | |
Definition | EMA IG 1.14 The product's name, including full name and possibly coded parts. |
Short | The product's name, including full name and possibly coded parts |
Control | 1..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
46. MedicinalProductDefinition.name.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
48. MedicinalProductDefinition.name.productName | |
Definition | EMA IG 1.14.1 The full product name. |
Short | The full product name |
Control | 1..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
50. MedicinalProductDefinition.name.usage | |
Definition | EMA IG 1.14.2 Country and jurisdiction where the name applies, and associated language. |
Short | Country and jurisdiction where the name applies |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
52. MedicinalProductDefinition.name.usage.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
54. MedicinalProductDefinition.name.usage.country | |
Definition | Country code for where this name applies. |
Short | Country code for where this name applies |
Control | 1..1 |
Binding | For example codes, see CountryValueSethttp://hl7.org/fhir/ValueSet/country (example to http://hl7.org/fhir/ValueSet/country )Jurisdiction codes |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
56. MedicinalProductDefinition.name.usage.country.coding | |
Definition | A reference to a code defined by a terminology system. |
Short | EMA or ISO codes for countryCode defined by a terminology system |
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. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..* |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.name.usage.country.coding . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
58. MedicinalProductDefinition.name.usage.country.coding:ema | |
Slice Name | ema |
Definition | A reference to a code defined by a terminology system. |
Short | Code defined by a terminology system |
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. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..1* |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
60. MedicinalProductDefinition.name.usage.country.coding:ema.system | |
Definition | The identification of the code system that defines the meaning of the symbol in the code. |
Short | Identity of the terminology system |
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously. |
Control | 10..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be unambiguous about the source of the definition of the symbol. |
Pattern Value | https://spor.ema.europa.eu/v1/lists/100000000002 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
62. MedicinalProductDefinition.name.usage.country.coding:iso | |
Slice Name | iso |
Definition | A reference to a code defined by a terminology system. |
Short | Code defined by a terminology system |
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. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..1* |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
64. MedicinalProductDefinition.name.usage.country.coding:iso.system | |
Definition | The identification of the code system that defines the meaning of the symbol in the code. |
Short | Identity of the terminology system |
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously. |
Control | 10..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be unambiguous about the source of the definition of the symbol. |
Pattern Value | https://www.hl7.org/fhir/valueset-country.html |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
66. MedicinalProductDefinition.name.usage.language | |
Definition | Language code for this name. |
Short | Language code for this name |
Control | 1..1 |
Binding | The codes SHALL be taken from AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0 )IETF language tag for a human language |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
68. MedicinalProductDefinition.name.usage.language.coding | |
Definition | A reference to a code defined by a terminology system. |
Short | EMA or ISO codes for countryCode defined by a terminology system |
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. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..* |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.name.usage.language.coding . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
70. MedicinalProductDefinition.name.usage.language.coding:ema | |
Slice Name | ema |
Definition | A reference to a code defined by a terminology system. |
Short | Code defined by a terminology system |
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. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..1* |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
72. MedicinalProductDefinition.name.usage.language.coding:ema.system | |
Definition | The identification of the code system that defines the meaning of the symbol in the code. |
Short | Identity of the terminology system |
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously. |
Control | 10..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be unambiguous about the source of the definition of the symbol. |
Pattern Value | https://spor.ema.europa.eu/v1/lists/100000072057 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
74. MedicinalProductDefinition.name.usage.language.coding:bcp | |
Slice Name | bcp |
Definition | A reference to a code defined by a terminology system. |
Short | Code defined by a terminology system |
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. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..1* |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
76. MedicinalProductDefinition.name.usage.language.coding:bcp.system | |
Definition | The identification of the code system that defines the meaning of the symbol in the code. |
Short | Identity of the terminology system |
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously. |
Control | 10..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be unambiguous about the source of the definition of the symbol. |
Pattern Value | http://hl7.org/fhir/ValueSet/all-languages |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Guidance on how to interpret the contents of this table can be found here
0. MedicinalProductDefinition | |
Definition | A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs). |
Short | Detailed definition of a medicinal product |
Control | 0..* |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty() )dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource ( contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() )dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated ( contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() )dom-5: If a resource is contained in another resource, it SHALL NOT have a security label ( contained.meta.security.empty() )dom-6: A resource should have narrative for robust management ( text.`div`.exists() ) |
2. MedicinalProductDefinition.id | |
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. |
Short | Logical id of this artifact |
Comments | Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case. |
Control | 0..1 |
Type | id |
Is Modifier | false |
Must Support | false |
Summary | true |
4. MedicinalProductDefinition.meta | |
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. |
Short | Metadata about the resource |
Control | 0..1 |
Type | Meta |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
6. MedicinalProductDefinition.implicitRules | |
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. |
Short | A set of rules under which this content was created |
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 its narrative along with other profiles, value sets, etc. |
Control | 0..1 |
Type | uri |
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
8. MedicinalProductDefinition.language | |
Definition | The base language in which the resource is written. |
Short | Language of the resource content |
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). |
Control | 0..1 |
Binding | The codes SHALL be taken from AllLanguages (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0 )IETF language tag for a human language |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
10. MedicinalProductDefinition.text | |
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. |
Short | Text summary of the resource, for human interpretation |
Comments | Contained resources do not have a 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. |
Control | 0..1 This element is affected by the following invariants: dom-6 |
Type | Narrative |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | narrative, html, xhtml, display |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
12. MedicinalProductDefinition.contained | |
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. |
Short | Contained, inline 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. |
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
Type | Resource |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | inline resources, anonymous resources, contained resources |
14. MedicinalProductDefinition.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
16. MedicinalProductDefinition.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
Must Support | false |
Summary | true |
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. |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
18. MedicinalProductDefinition.identifier | |
Definition | EMA IG 1.2 & 1.3. Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other. Not to be used for package or pharmaceutical product identifiers. |
Short | Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..* |
Type | Identifier |
Is Modifier | false |
Must Support | false |
Summary | true |
Alternate Names | MPID |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.identifier . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
20. MedicinalProductDefinition.identifier:mpid | |
Slice Name | mpid |
Definition | EMA IG 1.2. MPID if exists. For UNICOM testing data fake MPIDs are used (Country code + MAH LocID + unique code). |
Short | MPID |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1 |
Type | Identifier |
Is Modifier | false |
Must Support | false |
Summary | true |
Alternate Names | MPID |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
22. MedicinalProductDefinition.identifier:mpid.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
24. MedicinalProductDefinition.identifier:mpid.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.identifier.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
26. MedicinalProductDefinition.identifier:mpid.use | |
Definition | The purpose of this identifier. |
Short | usual | official | temp | secondary | old (If known) |
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
Control | 0..1 |
Binding | The codes SHALL be taken from IdentifierUse (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 )Identifies the purpose for this identifier, if known . |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
28. MedicinalProductDefinition.identifier:mpid.type | |
Definition | A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. |
Short | Description of identifier |
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. |
Control | 0..1 |
Binding | Unless not suitable, these codes SHALL be taken from IdentifierTypeCodes (extensible to http://hl7.org/fhir/ValueSet/identifier-type )A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
Type | CodeableConcept |
Is Modifier | false |
Summary | true |
Requirements | Allows users to make use of identifiers when the identifier system is not known. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
30. MedicinalProductDefinition.identifier:mpid.system | |
Definition | Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique. |
Short | The namespace for the identifier value |
Comments | Identifier.system is always case sensitive. |
Control | 1..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
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. |
Pattern Value | http://ema.europa.eu/fhir/mpId |
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
32. MedicinalProductDefinition.identifier:mpid.value | |
Definition | The portion of the identifier typically relevant to the user and which is unique within the context of the system. |
Short | The value that is unique |
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 http://hl7.org/fhir/StructureDefinition/rendered-value). 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. |
Control | 0..1 This element is affected by the following invariants: ident-1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Example | <br/><b>General</b>:123456 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
34. MedicinalProductDefinition.identifier:mpid.period | |
Definition | Time period during which identifier is/was valid for use. |
Short | Time period when id is/was valid for use |
Control | 0..1 |
Type | Period |
Is Modifier | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
36. MedicinalProductDefinition.identifier:mpid.assigner | |
Definition | Organization that issued/manages the identifier. |
Short | Organization that issued id (may be just text) |
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. |
Control | 0..1 |
Type | Reference(Organization) |
Is Modifier | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
38. MedicinalProductDefinition.identifier:pmsid | |
Slice Name | pmsid |
Definition | EMA IG 1.1. EMA Product Management System identifier if exists. For UNICOM testing data fake PMS IDs can be used |
Short | PMS ID |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1 |
Type | Identifier |
Is Modifier | false |
Must Support | false |
Summary | true |
Alternate Names | MPID |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
40. MedicinalProductDefinition.identifier:pmsid.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
42. MedicinalProductDefinition.identifier:pmsid.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.identifier.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
44. MedicinalProductDefinition.identifier:pmsid.use | |
Definition | The purpose of this identifier. |
Short | usual | official | temp | secondary | old (If known) |
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
Control | 0..1 |
Binding | The codes SHALL be taken from IdentifierUse (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 )Identifies the purpose for this identifier, if known . |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
46. MedicinalProductDefinition.identifier:pmsid.type | |
Definition | A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. |
Short | Description of identifier |
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. |
Control | 0..1 |
Binding | Unless not suitable, these codes SHALL be taken from IdentifierTypeCodes (extensible to http://hl7.org/fhir/ValueSet/identifier-type )A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
Type | CodeableConcept |
Is Modifier | false |
Summary | true |
Requirements | Allows users to make use of identifiers when the identifier system is not known. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
48. MedicinalProductDefinition.identifier:pmsid.system | |
Definition | Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique. |
Short | The namespace for the identifier value |
Comments | Identifier.system is always case sensitive. |
Control | 1..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
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. |
Pattern Value | http://ema.europa.eu/fhir/pmsId |
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
50. MedicinalProductDefinition.identifier:pmsid.value | |
Definition | The portion of the identifier typically relevant to the user and which is unique within the context of the system. |
Short | The value that is unique |
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 http://hl7.org/fhir/StructureDefinition/rendered-value). 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. |
Control | 0..1 This element is affected by the following invariants: ident-1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Example | <br/><b>General</b>:123456 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
52. MedicinalProductDefinition.identifier:pmsid.period | |
Definition | Time period during which identifier is/was valid for use. |
Short | Time period when id is/was valid for use |
Control | 0..1 |
Type | Period |
Is Modifier | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
54. MedicinalProductDefinition.identifier:pmsid.assigner | |
Definition | Organization that issued/manages the identifier. |
Short | Organization that issued id (may be just text) |
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. |
Control | 0..1 |
Type | Reference(Organization) |
Is Modifier | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
56. MedicinalProductDefinition.type | |
Definition | Regulatory type, e.g. Investigational or Authorized. |
Short | Regulatory type, e.g. Investigational or Authorized |
Control | 0..1 |
Binding | For example codes, see MedicinalProductType (example to http://hl7.org/fhir/ValueSet/medicinal-product-type )Overall defining type of this medicinal product. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
58. MedicinalProductDefinition.domain | |
Definition | EMA IG 1.3 |
Short | If this medicine applies to human or veterinary uses |
Control | 0..1 |
Binding | The codes SHALL be taken from EMA SPOR Domain (required to http://unicom-project.eu/fhir/d4-12/ValueSet/domain-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
60. MedicinalProductDefinition.version | |
Definition | A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product. |
Short | A business identifier relating to a specific version of the product |
Note | This is a business version Id, not a resource version Id (see discussion) |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
62. MedicinalProductDefinition.status | |
Definition | The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status. |
Short | Status of the product's data. Default 200000005004 'Current' |
Control | 0..1 |
Binding | The codes SHOULD be taken from PublicationStatus (preferred to http://hl7.org/fhir/ValueSet/publication-status )The lifecycle status of an artifact. |
Type | CodeableConcept |
Is Modifier | true because This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
64. MedicinalProductDefinition.statusDate | |
Definition | The date at which the given status became applicable. |
Short | The date at which the given status became applicable |
Control | 0..1 |
Type | dateTime |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
66. MedicinalProductDefinition.description | |
Definition | General description of this product. |
Short | General description of this product |
Control | 0..1 |
Type | markdown |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
68. MedicinalProductDefinition.combinedPharmaceuticalDoseForm | |
Definition | EMA IG 1.5 & 1.6. Authorised dose form for the whole product. As applicable in one of the SPOR RMS list Combined pharmaceutical dose form, Pharmaceutical dose form, Combined term, Combination Package |
Short | Authorised dose form for the product, incl combination package dose forms |
Control | 0..1 |
Binding | The codes SHALL be taken from EMA SPOR Authorised Dose Form (required to http://unicom-project.eu/fhir/d4-12/ValueSet/authorised-doseform-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
70. MedicinalProductDefinition.route | |
Definition | The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route. See also AdministrableProductDefinition resource. MedicinalProductDefinition.route is the same concept as AdministrableProductDefinition.routeOfAdministration.code, and they cannot be used together. |
Short | The path by which the product is taken into or makes contact with the body |
Control | 0..* |
Binding | For example codes, see SNOMEDCTRouteCodes (example to http://hl7.org/fhir/ValueSet/route-codes )A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
72. MedicinalProductDefinition.indication | |
Definition | Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseDefinition resource. An indication is a medical situation for which using the product is appropriate. |
Short | Description of indication(s) for this product, used when structured indications are not required |
Control | 0..1 |
Type | markdown |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
74. MedicinalProductDefinition.legalStatusOfSupply | |
Definition | EMA IG 1.7. Legal status of supply on the medicinal product level. The same information can be repeated/differentiated on the package level |
Short | Legal status of supply on the medicinal product level. |
Control | 0..1 |
Binding | The codes SHALL be taken from EMA SPOR Legal Status for the Supply (required to http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
76. MedicinalProductDefinition.additionalMonitoringIndicator | |
Definition | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirements. |
Short | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons |
Control | 0..1 |
Binding | For example codes, see AdditionalMonitoring (example to http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring )Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring). |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
78. MedicinalProductDefinition.specialMeasures | |
Definition | Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorization studies. |
Short | Whether the Medicinal Product is subject to special measures for regulatory reasons |
Control | 0..* |
Binding | For example codes, see SpecialMeasures (example to http://hl7.org/fhir/ValueSet/medicinal-product-special-measures )Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
80. MedicinalProductDefinition.pediatricUseIndicator | |
Definition | If authorised for use in children, or infants, neonates etc. |
Short | If authorised for use in children |
Control | 0..1 |
Binding | For example codes, see PediatricUse (example to http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use )Suitability for age groups, in particular children. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
82. MedicinalProductDefinition.classification | |
Definition | EMA IG 1.13 |
Short | ATC or other classification |
Control | 0..* |
Binding | For example codes, see ProductClassification (example to http://hl7.org/fhir/ValueSet/medicinal-product-classification )This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.classification . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
84. MedicinalProductDefinition.classification:atc | |
Slice Name | atc |
Definition | Allows the product to be classified by various systems, commonly WHO ATC. |
Short | Allows the product to be classified by various systems |
Control | 0..* |
Binding | For example codes, see ProductClassification (example to http://hl7.org/fhir/ValueSet/medicinal-product-classification )This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
86. MedicinalProductDefinition.classification:atc.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
88. MedicinalProductDefinition.classification:atc.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.classification.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
90. MedicinalProductDefinition.classification:atc.coding | |
Definition | EMA IG 1.13.3 |
Short | ATC classification |
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. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..* |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.classification.coding . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
92. MedicinalProductDefinition.classification:atc.coding:ema | |
Slice Name | ema |
Definition | A reference to a code defined by a terminology system. |
Short | ATC classification as EMA SPOR code |
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. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..1 |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
94. MedicinalProductDefinition.classification:atc.coding:ema.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
96. MedicinalProductDefinition.classification:atc.coding:ema.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.classification.coding.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
98. MedicinalProductDefinition.classification:atc.coding:ema.system | |
Definition | The identification of the code system that defines the meaning of the symbol in the code. |
Short | Identity of the terminology system |
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously. |
Control | 1..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be unambiguous about the source of the definition of the symbol. |
Pattern Value | https://spor.ema.europa.eu/v1/lists/100000093533 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
100. MedicinalProductDefinition.classification:atc.coding:ema.version | |
Definition | The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. |
Short | Version of the system - if relevant |
Comments | Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. |
Note | This is a business version Id, not a resource version Id (see discussion) |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
102. MedicinalProductDefinition.classification:atc.coding:ema.code | |
Definition | A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). |
Short | Symbol in syntax defined by the system |
Control | 0..1 This element is affected by the following invariants: cod-1 |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to refer to a particular code in the system. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
104. MedicinalProductDefinition.classification:atc.coding:ema.display | |
Definition | A representation of the meaning of the code in the system, following the rules of the system. |
Short | Representation defined by the system |
Control | 0..1 This element is affected by the following invariants: cod-1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be able to carry a human-readable meaning of the code for readers that do not know the system. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
106. MedicinalProductDefinition.classification:atc.coding:ema.userSelected | |
Definition | Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). |
Short | If this coding was chosen directly by the user |
Comments | Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. |
Control | 0..1 |
Type | boolean |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
108. MedicinalProductDefinition.classification:atc.coding:who | |
Slice Name | who |
Definition | A reference to a code defined by a terminology system. |
Short | ATC classification as WHO ATC code |
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. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..1 |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
110. MedicinalProductDefinition.classification:atc.coding:who.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
112. MedicinalProductDefinition.classification:atc.coding:who.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.classification.coding.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
114. MedicinalProductDefinition.classification:atc.coding:who.system | |
Definition | The identification of the code system that defines the meaning of the symbol in the code. |
Short | Identity of the terminology system |
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously. |
Control | 1..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be unambiguous about the source of the definition of the symbol. |
Pattern Value | http://www.whocc.no/atc |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
116. MedicinalProductDefinition.classification:atc.coding:who.version | |
Definition | The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. |
Short | Version of the system - if relevant |
Comments | Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. |
Note | This is a business version Id, not a resource version Id (see discussion) |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
118. MedicinalProductDefinition.classification:atc.coding:who.code | |
Definition | A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). |
Short | Symbol in syntax defined by the system |
Control | 0..1 This element is affected by the following invariants: cod-1 |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to refer to a particular code in the system. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
120. MedicinalProductDefinition.classification:atc.coding:who.display | |
Definition | A representation of the meaning of the code in the system, following the rules of the system. |
Short | Representation defined by the system |
Control | 0..1 This element is affected by the following invariants: cod-1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be able to carry a human-readable meaning of the code for readers that do not know the system. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
122. MedicinalProductDefinition.classification:atc.coding:who.userSelected | |
Definition | Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). |
Short | If this coding was chosen directly by the user |
Comments | Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. |
Control | 0..1 |
Type | boolean |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
124. MedicinalProductDefinition.classification:atc.text | |
Definition | A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. |
Short | Plain text representation of the concept |
Comments | Very often the text is the same as a displayName of one of the codings. |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
126. MedicinalProductDefinition.marketingStatus | |
Definition | Marketing status of the medicinal product, in contrast to marketing authorization. This refers to the product being actually 'on the market' as opposed to being allowed to be on the market (which is an authorization). |
Short | Marketing status of the medicinal product, in contrast to marketing authorization |
Control | 0..* |
Type | MarketingStatus |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
128. MedicinalProductDefinition.packagedMedicinalProduct | |
Definition | Package type for the product. See also the PackagedProductDefinition resource. |
Short | Package type for the product |
Control | 0..* |
Binding | For example codes, see MedicinalProductPackageType (example to http://hl7.org/fhir/ValueSet/medicinal-product-package-type )Types of medicinal product packs |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
130. MedicinalProductDefinition.comprisedOf | |
Definition | Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes. Used as a direct link when the item's packaging is not being recorded (see also PackagedProductDefinition.package.containedItem.item). |
Short | Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes |
Control | 0..* |
Type | Reference(ManufacturedItemDefinition, DeviceDefinition) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
132. MedicinalProductDefinition.ingredient | |
Definition | The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes. |
Short | The ingredients of this medicinal product - when not detailed in other resources |
Control | 0..* |
Binding | For example codes, see SNOMEDCTSubstanceCodes (example to http://hl7.org/fhir/ValueSet/substance-codes )This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
134. MedicinalProductDefinition.impurity | |
Definition | Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products. |
Short | Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product |
Control | 0..* |
Binding | For example codes, see SNOMEDCTSubstanceCodes (example to http://hl7.org/fhir/ValueSet/substance-codes )This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. |
Type | CodeableReference(SubstanceDefinition) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
136. MedicinalProductDefinition.attachedDocument | |
Definition | Additional information or supporting documentation about the medicinal product. |
Short | Additional documentation about the medicinal product |
Control | 0..* |
Type | Reference(DocumentReference) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
138. MedicinalProductDefinition.masterFile | |
Definition | A master file for the medicinal product (e.g. Pharmacovigilance System Master File). Drug master files (DMFs) are documents submitted to regulatory agencies to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of drug products. |
Short | A master file for the medicinal product (e.g. Pharmacovigilance System Master File) |
Control | 0..* |
Type | Reference(DocumentReference) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
140. MedicinalProductDefinition.contact | |
Definition | A product specific contact, person (in a role), or an organization. |
Short | A product specific contact, person (in a role), or an organization |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
142. MedicinalProductDefinition.contact.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
144. MedicinalProductDefinition.contact.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
146. MedicinalProductDefinition.contact.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
148. MedicinalProductDefinition.contact.type | |
Definition | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information. |
Short | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information |
Control | 0..1 |
Binding | For example codes, see ProductContactType (example to http://hl7.org/fhir/ValueSet/medicinal-product-contact-type )Extra measures defined for a Medicinal Product, such as heightened reporting requirements. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
150. MedicinalProductDefinition.contact.contact | |
Definition | A product specific contact, person (in a role), or an organization. |
Short | A product specific contact, person (in a role), or an organization |
Control | 1..1 |
Type | Reference(Organization, PractitionerRole) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
152. MedicinalProductDefinition.clinicalTrial | |
Definition | Clinical trials or studies that this product is involved in. |
Short | Clinical trials or studies that this product is involved in |
Control | 0..* |
Type | Reference(ResearchStudy) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
154. MedicinalProductDefinition.code | |
Definition | A code that this product is known by, usually within some formal terminology, perhaps assigned by a third party (i.e. not the manufacturer or regulator). Products (types of medications) tend to be known by identifiers during development and within regulatory process. However when they are prescribed they tend to be identified by codes. The same product may be have multiple codes, applied to it by multiple organizations. |
Short | A code that this product is known by, within some formal terminology |
Control | 0..* |
Binding | For example codes, see SNOMEDCTMedicationCodes (example to http://hl7.org/fhir/ValueSet/medication-codes )A coded concept that defines the type of a medication. |
Type | Coding |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
156. MedicinalProductDefinition.name | |
Definition | EMA IG 1.14 |
Short | The product's name, including full name and possibly coded parts |
Control | 1..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
158. MedicinalProductDefinition.name.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
160. MedicinalProductDefinition.name.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
162. MedicinalProductDefinition.name.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
164. MedicinalProductDefinition.name.productName | |
Definition | EMA IG 1.14.1 |
Short | The full product name |
Control | 1..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
166. MedicinalProductDefinition.name.type | |
Definition | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary. |
Short | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary |
Control | 0..1 |
Binding | For example codes, see ProductNameType (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-type )Type of a name for a Medicinal Product. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
168. MedicinalProductDefinition.name.part | |
Definition | Coding words or phrases of the name. |
Short | Coding words or phrases of the name |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
170. MedicinalProductDefinition.name.part.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
172. MedicinalProductDefinition.name.part.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
174. MedicinalProductDefinition.name.part.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
176. MedicinalProductDefinition.name.part.part | |
Definition | A fragment of a product name. |
Short | A fragment of a product name |
Control | 1..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
178. MedicinalProductDefinition.name.part.type | |
Definition | Identifying type for this part of the name (e.g. strength part). |
Short | Identifying type for this part of the name (e.g. strength part) |
Control | 1..1 |
Binding | For example codes, see ProductNamePartType (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type )Type of part of a name for a Medicinal Product. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
180. MedicinalProductDefinition.name.usage | |
Definition | EMA IG 1.14.2 |
Short | Country and jurisdiction where the name applies |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
182. MedicinalProductDefinition.name.usage.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
184. MedicinalProductDefinition.name.usage.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
186. MedicinalProductDefinition.name.usage.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
188. MedicinalProductDefinition.name.usage.country | |
Definition | Country code for where this name applies. |
Short | Country code for where this name applies |
Control | 1..1 |
Binding | For example codes, see CountryValueSet (example to http://hl7.org/fhir/ValueSet/country )Jurisdiction codes |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
190. MedicinalProductDefinition.name.usage.country.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
192. MedicinalProductDefinition.name.usage.country.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.name.usage.country.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
194. MedicinalProductDefinition.name.usage.country.coding | |
Definition | A reference to a code defined by a terminology system. |
Short | EMA or ISO codes for country |
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. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..* |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.name.usage.country.coding . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
196. MedicinalProductDefinition.name.usage.country.coding:ema | |
Slice Name | ema |
Definition | A reference to a code defined by a terminology system. |
Short | Code defined by a terminology system |
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. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..1 |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
198. MedicinalProductDefinition.name.usage.country.coding:ema.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
200. MedicinalProductDefinition.name.usage.country.coding:ema.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.name.usage.country.coding.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
202. MedicinalProductDefinition.name.usage.country.coding:ema.system | |
Definition | The identification of the code system that defines the meaning of the symbol in the code. |
Short | Identity of the terminology system |
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously. |
Control | 1..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be unambiguous about the source of the definition of the symbol. |
Pattern Value | https://spor.ema.europa.eu/v1/lists/100000000002 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
204. MedicinalProductDefinition.name.usage.country.coding:ema.version | |
Definition | The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. |
Short | Version of the system - if relevant |
Comments | Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. |
Note | This is a business version Id, not a resource version Id (see discussion) |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
206. MedicinalProductDefinition.name.usage.country.coding:ema.code | |
Definition | A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). |
Short | Symbol in syntax defined by the system |
Control | 0..1 This element is affected by the following invariants: cod-1 |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to refer to a particular code in the system. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
208. MedicinalProductDefinition.name.usage.country.coding:ema.display | |
Definition | A representation of the meaning of the code in the system, following the rules of the system. |
Short | Representation defined by the system |
Control | 0..1 This element is affected by the following invariants: cod-1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be able to carry a human-readable meaning of the code for readers that do not know the system. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
210. MedicinalProductDefinition.name.usage.country.coding:ema.userSelected | |
Definition | Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). |
Short | If this coding was chosen directly by the user |
Comments | Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. |
Control | 0..1 |
Type | boolean |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
212. MedicinalProductDefinition.name.usage.country.coding:iso | |
Slice Name | iso |
Definition | A reference to a code defined by a terminology system. |
Short | Code defined by a terminology system |
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. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..1 |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
214. MedicinalProductDefinition.name.usage.country.coding:iso.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
216. MedicinalProductDefinition.name.usage.country.coding:iso.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.name.usage.country.coding.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
218. MedicinalProductDefinition.name.usage.country.coding:iso.system | |
Definition | The identification of the code system that defines the meaning of the symbol in the code. |
Short | Identity of the terminology system |
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously. |
Control | 1..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be unambiguous about the source of the definition of the symbol. |
Pattern Value | https://www.hl7.org/fhir/valueset-country.html |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
220. MedicinalProductDefinition.name.usage.country.coding:iso.version | |
Definition | The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. |
Short | Version of the system - if relevant |
Comments | Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. |
Note | This is a business version Id, not a resource version Id (see discussion) |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
222. MedicinalProductDefinition.name.usage.country.coding:iso.code | |
Definition | A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). |
Short | Symbol in syntax defined by the system |
Control | 0..1 This element is affected by the following invariants: cod-1 |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to refer to a particular code in the system. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
224. MedicinalProductDefinition.name.usage.country.coding:iso.display | |
Definition | A representation of the meaning of the code in the system, following the rules of the system. |
Short | Representation defined by the system |
Control | 0..1 This element is affected by the following invariants: cod-1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be able to carry a human-readable meaning of the code for readers that do not know the system. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
226. MedicinalProductDefinition.name.usage.country.coding:iso.userSelected | |
Definition | Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). |
Short | If this coding was chosen directly by the user |
Comments | Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. |
Control | 0..1 |
Type | boolean |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
228. MedicinalProductDefinition.name.usage.country.text | |
Definition | A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. |
Short | Plain text representation of the concept |
Comments | Very often the text is the same as a displayName of one of the codings. |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
230. MedicinalProductDefinition.name.usage.jurisdiction | |
Definition | Jurisdiction code for where this name applies. A jurisdiction may be a sub- or supra-national entity (e.g. a state or a geographic region). |
Short | Jurisdiction code for where this name applies |
Control | 0..1 |
Binding | For example codes, see JurisdictionValueSet (example to http://hl7.org/fhir/ValueSet/jurisdiction )Jurisdiction codes |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
232. MedicinalProductDefinition.name.usage.language | |
Definition | Language code for this name. |
Short | Language code for this name |
Control | 1..1 |
Binding | The codes SHALL be taken from AllLanguages (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0 )IETF language tag for a human language |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
234. MedicinalProductDefinition.name.usage.language.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
236. MedicinalProductDefinition.name.usage.language.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.name.usage.language.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
238. MedicinalProductDefinition.name.usage.language.coding | |
Definition | A reference to a code defined by a terminology system. |
Short | EMA or ISO codes for country |
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. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..* |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.name.usage.language.coding . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
240. MedicinalProductDefinition.name.usage.language.coding:ema | |
Slice Name | ema |
Definition | A reference to a code defined by a terminology system. |
Short | Code defined by a terminology system |
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. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..1 |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
242. MedicinalProductDefinition.name.usage.language.coding:ema.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
244. MedicinalProductDefinition.name.usage.language.coding:ema.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.name.usage.language.coding.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
246. MedicinalProductDefinition.name.usage.language.coding:ema.system | |
Definition | The identification of the code system that defines the meaning of the symbol in the code. |
Short | Identity of the terminology system |
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously. |
Control | 1..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be unambiguous about the source of the definition of the symbol. |
Pattern Value | https://spor.ema.europa.eu/v1/lists/100000072057 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
248. MedicinalProductDefinition.name.usage.language.coding:ema.version | |
Definition | The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. |
Short | Version of the system - if relevant |
Comments | Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. |
Note | This is a business version Id, not a resource version Id (see discussion) |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
250. MedicinalProductDefinition.name.usage.language.coding:ema.code | |
Definition | A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). |
Short | Symbol in syntax defined by the system |
Control | 0..1 This element is affected by the following invariants: cod-1 |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to refer to a particular code in the system. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
252. MedicinalProductDefinition.name.usage.language.coding:ema.display | |
Definition | A representation of the meaning of the code in the system, following the rules of the system. |
Short | Representation defined by the system |
Control | 0..1 This element is affected by the following invariants: cod-1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be able to carry a human-readable meaning of the code for readers that do not know the system. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
254. MedicinalProductDefinition.name.usage.language.coding:ema.userSelected | |
Definition | Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). |
Short | If this coding was chosen directly by the user |
Comments | Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. |
Control | 0..1 |
Type | boolean |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
256. MedicinalProductDefinition.name.usage.language.coding:bcp | |
Slice Name | bcp |
Definition | A reference to a code defined by a terminology system. |
Short | Code defined by a terminology system |
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. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..1 |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
258. MedicinalProductDefinition.name.usage.language.coding:bcp.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
260. MedicinalProductDefinition.name.usage.language.coding:bcp.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on MedicinalProductDefinition.name.usage.language.coding.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
262. MedicinalProductDefinition.name.usage.language.coding:bcp.system | |
Definition | The identification of the code system that defines the meaning of the symbol in the code. |
Short | Identity of the terminology system |
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously. |
Control | 1..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be unambiguous about the source of the definition of the symbol. |
Pattern Value | http://hl7.org/fhir/ValueSet/all-languages |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
264. MedicinalProductDefinition.name.usage.language.coding:bcp.version | |
Definition | The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. |
Short | Version of the system - if relevant |
Comments | Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. |
Note | This is a business version Id, not a resource version Id (see discussion) |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
266. MedicinalProductDefinition.name.usage.language.coding:bcp.code | |
Definition | A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). |
Short | Symbol in syntax defined by the system |
Control | 0..1 This element is affected by the following invariants: cod-1 |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to refer to a particular code in the system. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
268. MedicinalProductDefinition.name.usage.language.coding:bcp.display | |
Definition | A representation of the meaning of the code in the system, following the rules of the system. |
Short | Representation defined by the system |
Control | 0..1 This element is affected by the following invariants: cod-1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be able to carry a human-readable meaning of the code for readers that do not know the system. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
270. MedicinalProductDefinition.name.usage.language.coding:bcp.userSelected | |
Definition | Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). |
Short | If this coding was chosen directly by the user |
Comments | Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. |
Control | 0..1 |
Type | boolean |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
272. MedicinalProductDefinition.name.usage.language.text | |
Definition | A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. |
Short | Plain text representation of the concept |
Comments | Very often the text is the same as a displayName of one of the codings. |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
274. MedicinalProductDefinition.crossReference | |
Definition | Reference to another product, e.g. for linking authorised to investigational product, or a virtual product. |
Short | Reference to another product, e.g. for linking authorised to investigational product |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
276. MedicinalProductDefinition.crossReference.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
278. MedicinalProductDefinition.crossReference.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
280. MedicinalProductDefinition.crossReference.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
282. MedicinalProductDefinition.crossReference.product | |
Definition | Reference to another product, e.g. for linking authorised to investigational product. |
Short | Reference to another product, e.g. for linking authorised to investigational product |
Control | 1..1 |
Type | CodeableReference(MedicinalProductDefinition) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
284. MedicinalProductDefinition.crossReference.type | |
Definition | The type of relationship, for instance branded to generic, virtual to actual product, product to development product (investigational), parallel import version. |
Short | The type of relationship, for instance branded to generic or virtual to actual product |
Control | 0..1 |
Binding | For example codes, see ProductCrossReferenceType (example to http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type )Extra measures defined for a Medicinal Product, such as heightened reporting requirements. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
286. MedicinalProductDefinition.operation | |
Definition | A manufacturing or administrative process or step associated with (or performed on) the medicinal product. |
Short | A manufacturing or administrative process for the medicinal product |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
288. MedicinalProductDefinition.operation.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
290. MedicinalProductDefinition.operation.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
292. MedicinalProductDefinition.operation.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
294. MedicinalProductDefinition.operation.type | |
Definition | The type of manufacturing operation e.g. manufacturing itself, re-packaging. For the authorization of this, a RegulatedAuthorization would point to the same plan or activity referenced here. |
Short | The type of manufacturing operation e.g. manufacturing itself, re-packaging |
Control | 0..1 |
Type | CodeableReference(ActivityDefinition, PlanDefinition) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
296. MedicinalProductDefinition.operation.effectiveDate | |
Definition | Date range of applicability. |
Short | Date range of applicability |
Control | 0..1 |
Type | Period |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
298. MedicinalProductDefinition.operation.organization | |
Definition | The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent. |
Short | The organization responsible for the particular process, e.g. the manufacturer or importer |
Control | 0..* |
Type | Reference(Organization) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
300. MedicinalProductDefinition.operation.confidentialityIndicator | |
Definition | Specifies whether this particular business or manufacturing process is considered proprietary or confidential. |
Short | Specifies whether this process is considered proprietary or confidential |
Control | 0..1 |
Binding | For example codes, see ProductConfidentiality (example to http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality )Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
302. MedicinalProductDefinition.characteristic | |
Definition | Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import". |
Short | Key product features such as "sugar free", "modified release" |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
304. MedicinalProductDefinition.characteristic.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
306. MedicinalProductDefinition.characteristic.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
308. MedicinalProductDefinition.characteristic.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
310. MedicinalProductDefinition.characteristic.type | |
Definition | A code expressing the type of characteristic. |
Short | A code expressing the type of characteristic |
Control | 1..1 |
Binding | For example codes, see ProductCharacteristic (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes )This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
312. MedicinalProductDefinition.characteristic.value[x] | |
Definition | A value for the characteristic.text. |
Short | A value for the characteristic |
Comments | Text, as markdown, is intended to be used only when the item cannot ever reasonably be coded. Otherwise, for cases where a code is not available, but is feasible, use CodeableConcept.text. |
Control | 0..1 |
Type | Choice of: CodeableConcept, markdown, Quantity, integer, date, boolean, Attachment |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |