Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

## Resource Profile: BatchFormulaMedicinalProduct - Detailed Descriptions

Page standards status: Trial-use | Maturity Level: 2

Definitions for the pqcmc-batch-formula-product resource profile.

- Key Elements Table
- Differential Elements Table
- Snapshot Elements Table

Guidance on how to interpret the contents of this table can be foundhere

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 | 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 | optional user designated identifierBusiness 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 | true
Summary | true
Alternate Names | MPID
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. 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 | The status within the lifecycle of this product record
Control | 0..1
Binding | The codes SHOULD be taken from PublicationStatus http://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()))
12. MedicinalProductDefinition.combinedPharmaceuticalDoseForm
Definition | The form in which active and/or inert ingredient(s) are physically presented as indicated on the packaging according to the USP. [Source: NCI EVS - C42636] Examples: tablet, capsule, solution, cream, etc. that contains a drug substance generally, but not necessarily, in association with excipients. [Source: ICH Q1A(R2)] See also 21 CFR 314.3. Note: If there is a new dosage form that does not exist in the controlled terminology, then propose this new dosage form during sponsor meetings with FDA. SME comment -- this is the marketed dosage form 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 | Product Dosage FormThe dose form for a single part product, or combined form of a multiple part product
Control | 10..1
Binding | The codes SHALL be taken from For example codes, see Pharmaceutical Dosage Form Terminology http://hl7.org/fhir/ValueSet/combined-dose-form (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. MedicinalProductDefinition.route
Definition | Designation of the part of the body through which or into which, or the way in which, the medicinal product is intended to be introduced. In some cases a medicinal product can be intended for more than one route and/or method of administration. [Source: NCI E C38114] 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 | Route of AdministrationThe path by which the product is taken into or makes contact with the body
Control | 10..*
Binding | The codes SHALL be taken from For example codes, see Drug Route Of Administration Terminology http://hl7.org/fhir/ValueSet/route-codes (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. 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 | 10..*
Type | Reference(Literal Reference)(Drug Product Batch Formula, ManufacturedItemDefinition, DeviceDefinition)bundled
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. MedicinalProductDefinition.name
Definition | 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..2*
Type | BackboneElement
Is Modifier | false
Must Support | true
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.name`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type
20. 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())
22. MedicinalProductDefinition.name.productName
Definition | 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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. 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 | 10..1
Binding | The codes SHALL be taken from For example codes, see Product Name Types Terminology http://hl7.org/fhir/ValueSet/medicinal-product-name-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. MedicinalProductDefinition.name:Proprietary
Slice Name | Proprietary
Definition | The product's name, including full name and possibly coded parts.
Short | The product's name, including full name and possibly coded parts
Control | 01..1*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. MedicinalProductDefinition.name:Proprietary.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())
30. MedicinalProductDefinition.name:Proprietary.productName
Definition | 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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. MedicinalProductDefinition.name:Proprietary.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 | 10..1
Binding | The codes SHALL be taken from For example codes, see Product Name Types Terminology http://hl7.org/fhir/ValueSet/medicinal-product-name-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C71898", "display" : "Proprietary Name" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. MedicinalProductDefinition.name:Proprietary.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. MedicinalProductDefinition.name:Proprietary.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())
38. MedicinalProductDefinition.name:Proprietary.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. MedicinalProductDefinition.name:Proprietary.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 | The codes SHALL be taken from For example codes, see PQCMC Name Part Terminology http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. MedicinalProductDefinition.name:NonProprietary
Slice Name | NonProprietary
Definition | 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..1*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) cmc-strength-name-must-reference-scientific: strength parts must modify a scientific part, scientific parts must be modified by a strength part. The same scientific part cannot appear more than once (`defineVariable('system','http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2').select( defineVariable('strengthReferences',part.type.where(coding.exists(code = 'STR' and system = %system)).text).select( defineVariable('scientificNames',part.where(type.coding.exists(code = 'SCI' and system = %system)).part).select( %strengthReferences = %scientificNames and %scientificNames.distinct() = %scientificNames )))`)
44. MedicinalProductDefinition.name:NonProprietary.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())
46. MedicinalProductDefinition.name:NonProprietary.productName
Definition | 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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. MedicinalProductDefinition.name:NonProprietary.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 | 10..1
Binding | The codes SHALL be taken from For example codes, see Product Name Types Terminology http://hl7.org/fhir/ValueSet/medicinal-product-name-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C96971", "display" : "Nonproprietary Name" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. MedicinalProductDefinition.name:NonProprietary.part
Definition | Name Parts are a means of specifying a range of acceptable forms of the name of a product. Note: The minimum is the scientific name. Coding words or phrases of the name.
Short | Coding words or phrases of the name
Control | 20..*
Type | BackboneElement
Is Modifier | false
Must Support | true
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.name.part`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type
52. MedicinalProductDefinition.name:NonProprietary.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())
54. MedicinalProductDefinition.name:NonProprietary.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. MedicinalProductDefinition.name:NonProprietary.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 | The codes SHALL be taken from For example codes, see PQCMC Name Part Terminology http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
58. MedicinalProductDefinition.name:NonProprietary.part:Scientific
Slice Name | Scientific
Definition | Coding words or phrases of the name.
Short | Coding words or phrases of the name
Control | 10..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
60. MedicinalProductDefinition.name:NonProprietary.part:Scientific.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())
62. MedicinalProductDefinition.name:NonProprietary.part:Scientific.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
64. MedicinalProductDefinition.name:NonProprietary.part:Scientific.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 | The codes SHALL be taken from For example codes, see PQCMC Name Part Terminology http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "SCI" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
66. MedicinalProductDefinition.name:NonProprietary.part:Invented
Slice Name | Invented
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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. MedicinalProductDefinition.name:NonProprietary.part:Invented.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())
70. MedicinalProductDefinition.name:NonProprietary.part:Invented.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
72. MedicinalProductDefinition.name:NonProprietary.part:Invented.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 | The codes SHALL be taken from For example codes, see PQCMC Name Part Terminology http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "INV" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
74. MedicinalProductDefinition.name:NonProprietary.part:Formulation
Slice Name | Formulation
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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
76. MedicinalProductDefinition.name:NonProprietary.part:Formulation.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())
78. MedicinalProductDefinition.name:NonProprietary.part:Formulation.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
80. MedicinalProductDefinition.name:NonProprietary.part:Formulation.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 | The codes SHALL be taken from For example codes, see PQCMC Name Part Terminology http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "FORMUL" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
82. MedicinalProductDefinition.name:NonProprietary.part:Strength
Slice Name | Strength
Definition | Coding words or phrases of the name.
Short | Coding words or phrases of the name
Control | 10..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
84. MedicinalProductDefinition.name:NonProprietary.part:Strength.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())
86. MedicinalProductDefinition.name:NonProprietary.part:Strength.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
88. MedicinalProductDefinition.name:NonProprietary.part:Strength.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 | The codes SHALL be taken from For example codes, see PQCMC Name Part Terminology http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "STR" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
90. MedicinalProductDefinition.name:NonProprietary.part:Strength.type.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 | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
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()))
92. MedicinalProductDefinition.name:NonProprietary.part:Container
Slice Name | Container
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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
94. MedicinalProductDefinition.name:NonProprietary.part:Container.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())
96. MedicinalProductDefinition.name:NonProprietary.part:Container.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
98. MedicinalProductDefinition.name:NonProprietary.part:Container.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 | The codes SHALL be taken from For example codes, see PQCMC Name Part Terminology http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "CON" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
100. MedicinalProductDefinition.name:NonProprietary.part:Form
Slice Name | Form
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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
102. MedicinalProductDefinition.name:NonProprietary.part:Form.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())
104. MedicinalProductDefinition.name:NonProprietary.part:Form.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
106. MedicinalProductDefinition.name:NonProprietary.part:Form.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 | The codes SHALL be taken from For example codes, see PQCMC Name Part Terminology http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "FRM" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
108. MedicinalProductDefinition.name:NonProprietary.part:Device
Slice Name | Device
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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
110. MedicinalProductDefinition.name:NonProprietary.part:Device.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())
112. MedicinalProductDefinition.name:NonProprietary.part:Device.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
114. MedicinalProductDefinition.name:NonProprietary.part:Device.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 | The codes SHALL be taken from For example codes, see PQCMC Name Part Terminology http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "DEV" }] }`
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 foundhere

0. MedicinalProductDefinition
2. MedicinalProductDefinition.identifier
Short | optional user designated identifier
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1
Must Support | true
4. MedicinalProductDefinition.combinedPharmaceuticalDoseForm
Definition | The form in which active and/or inert ingredient(s) are physically presented as indicated on the packaging according to the USP. [Source: NCI EVS - C42636] Examples: tablet, capsule, solution, cream, etc. that contains a drug substance generally, but not necessarily, in association with excipients. [Source: ICH Q1A(R2)] See also 21 CFR 314.3. Note: If there is a new dosage form that does not exist in the controlled terminology, then propose this new dosage form during sponsor meetings with FDA. SME comment -- this is the marketed dosage form
Short | Product Dosage Form
Control | 1..?
Binding | The codes SHALL be taken from Pharmaceutical Dosage Form Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology` )
Must Support | true
6. MedicinalProductDefinition.route
Definition | Designation of the part of the body through which or into which, or the way in which, the medicinal product is intended to be introduced. In some cases a medicinal product can be intended for more than one route and/or method of administration. [Source: NCI E C38114]
Short | Route of Administration
Control | 1..?
Binding | The codes SHALL be taken from Drug Route Of Administration Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology` )
Must Support | true
8. MedicinalProductDefinition.comprisedOf
Control | 1..?
Type | Reference(Literal Reference)(Drug Product Batch Formula)bundled
Must Support | true
10. MedicinalProductDefinition.name
Control | 0..2
Must Support | true
Slicing | This element introduces a set of slices on `MedicinalProductDefinition.name`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type
12. MedicinalProductDefinition.name.productName
Must Support | true
14. MedicinalProductDefinition.name.type
Control | 1..?
Binding | The codes SHALL be taken from Product Name Types Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` )
Must Support | true
16. MedicinalProductDefinition.name:Proprietary
Slice Name | Proprietary
Control | 0..1
Must Support | true
18. MedicinalProductDefinition.name:Proprietary.type
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C71898", "display" : "Proprietary Name" }] }`
20. MedicinalProductDefinition.name:Proprietary.part
Must Support | true
Slicing | This element introduces a set of slices on `MedicinalProductDefinition.name.part`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type
22. MedicinalProductDefinition.name:Proprietary.part.part
Must Support | true
24. MedicinalProductDefinition.name:Proprietary.part.type
Binding | The codes SHALL be taken from PQCMC Name Part Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Must Support | true
26. MedicinalProductDefinition.name:NonProprietary
Slice Name | NonProprietary
Control | 1..1
Must Support | true
Invariants | cmc-strength-name-must-reference-scientific: strength parts must modify a scientific part, scientific parts must be modified by a strength part. The same scientific part cannot appear more than once (`defineVariable('system','http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2').select( defineVariable('strengthReferences',part.type.where(coding.exists(code = 'STR' and system = %system)).text).select( defineVariable('scientificNames',part.where(type.coding.exists(code = 'SCI' and system = %system)).part).select( %strengthReferences = %scientificNames and %scientificNames.distinct() = %scientificNames )))`)
28. MedicinalProductDefinition.name:NonProprietary.type
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C96971", "display" : "Nonproprietary Name" }] }`
30. MedicinalProductDefinition.name:NonProprietary.part
Definition | Name Parts are a means of specifying a range of acceptable forms of the name of a product. Note: The minimum is the scientific name.
Control | 2..?
Must Support | true
Slicing | This element introduces a set of slices on `MedicinalProductDefinition.name.part`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type
32. MedicinalProductDefinition.name:NonProprietary.part.part
Must Support | true
34. MedicinalProductDefinition.name:NonProprietary.part.type
Binding | The codes SHALL be taken from PQCMC Name Part Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Must Support | true
36. MedicinalProductDefinition.name:NonProprietary.part:Scientific
Slice Name | Scientific
Control | 1..*
Must Support | true
38. MedicinalProductDefinition.name:NonProprietary.part:Scientific.type
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "SCI" }] }`
40. MedicinalProductDefinition.name:NonProprietary.part:Invented
Slice Name | Invented
Control | 0..*
Must Support | true
42. MedicinalProductDefinition.name:NonProprietary.part:Invented.type
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "INV" }] }`
44. MedicinalProductDefinition.name:NonProprietary.part:Formulation
Slice Name | Formulation
Control | 0..*
Must Support | true
46. MedicinalProductDefinition.name:NonProprietary.part:Formulation.type
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "FORMUL" }] }`
48. MedicinalProductDefinition.name:NonProprietary.part:Strength
Slice Name | Strength
Control | 1..*
Must Support | true
50. MedicinalProductDefinition.name:NonProprietary.part:Strength.type
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "STR" }] }`
52. MedicinalProductDefinition.name:NonProprietary.part:Strength.type.text
Control | 1..?
Must Support | true
54. MedicinalProductDefinition.name:NonProprietary.part:Container
Slice Name | Container
Control | 0..*
Must Support | true
56. MedicinalProductDefinition.name:NonProprietary.part:Container.type
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "CON" }] }`
58. MedicinalProductDefinition.name:NonProprietary.part:Form
Slice Name | Form
Control | 0..*
Must Support | true
60. MedicinalProductDefinition.name:NonProprietary.part:Form.type
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "FRM" }] }`
62. MedicinalProductDefinition.name:NonProprietary.part:Device
Slice Name | Device
Control | 0..*
Must Support | true
64. MedicinalProductDefinition.name:NonProprietary.part:Device.type
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "DEV" }] }`

Guidance on how to interpret the contents of this table can be foundhere

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 | 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 | optional user designated identifier
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1
Type | Identifier
Is Modifier | false
Must Support | true
Summary | true
Alternate Names | MPID
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
20. 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())`)
22. MedicinalProductDefinition.domain
Definition | If this medicine applies to human or veterinary uses.
Short | If this medicine applies to human or veterinary uses
Control | 0..1
Binding | For example codes, see MedicinalProductDomain (example to `http://hl7.org/fhir/ValueSet/medicinal-product-domain` ) Applicable domain for this product (e.g. human, veterinary).
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.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())`)
26. 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 | The status within the lifecycle of this product record
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())`)
28. 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())`)
30. 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())`)
32. MedicinalProductDefinition.combinedPharmaceuticalDoseForm
Definition | The form in which active and/or inert ingredient(s) are physically presented as indicated on the packaging according to the USP. [Source: NCI EVS - C42636] Examples: tablet, capsule, solution, cream, etc. that contains a drug substance generally, but not necessarily, in association with excipients. [Source: ICH Q1A(R2)] See also 21 CFR 314.3. Note: If there is a new dosage form that does not exist in the controlled terminology, then propose this new dosage form during sponsor meetings with FDA. SME comment -- this is the marketed dosage form
Short | Product Dosage Form
Control | 1..1
Binding | The codes SHALL be taken from Pharmaceutical Dosage Form Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
34. MedicinalProductDefinition.route
Definition | Designation of the part of the body through which or into which, or the way in which, the medicinal product is intended to be introduced. In some cases a medicinal product can be intended for more than one route and/or method of administration. [Source: NCI E C38114]
Short | Route of Administration
Control | 1..*
Binding | The codes SHALL be taken from Drug Route Of Administration Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
36. 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())`)
38. MedicinalProductDefinition.legalStatusOfSupply
Definition | The legal status of supply of the medicinal product as classified by the regulator.
Short | The legal status of supply of the medicinal product as classified by the regulator
Control | 0..1
Binding | For example codes, see LegalStatusOfSupply (example to `http://hl7.org/fhir/ValueSet/legal-status-of-supply` ) The prescription supply types appropriate to 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())`)
40. 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())`)
42. 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())`)
44. 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())`)
46. MedicinalProductDefinition.classification
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())`)
48. 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())`)
50. 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())`)
52. 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 | 1..*
Type | Reference(Literal Reference)(Drug Product Batch Formula)bundled
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
54. 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())`)
56. 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())`)
58. 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())`)
60. 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())`)
62. 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())`)
64. 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
66. 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()`)
68. 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()`)
70. 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())`)
72. 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())`)
74. 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())`)
76. 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())`)
78. MedicinalProductDefinition.name
Definition | 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..2
Type | BackboneElement
Is Modifier | false
Must Support | true
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.name`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type
80. 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
82. 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()`)
84. 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()`)
86. MedicinalProductDefinition.name.productName
Definition | 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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
88. 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 | 1..1
Binding | The codes SHALL be taken from Product Name Types Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
90. 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())`)
92. 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
94. 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()`)
96. 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()`)
98. 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())`)
100. 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())`)
102. MedicinalProductDefinition.name.usage
Definition | 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())`)
104. 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
106. 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()`)
108. 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()`)
110. 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())`)
112. 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())`)
114. 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())`)
116. MedicinalProductDefinition.name:Proprietary
Slice Name | Proprietary
Definition | The product's name, including full name and possibly coded parts.
Short | The product's name, including full name and possibly coded parts
Control | 0..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
118. MedicinalProductDefinition.name:Proprietary.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
120. MedicinalProductDefinition.name:Proprietary.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()`)
122. MedicinalProductDefinition.name:Proprietary.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()`)
124. MedicinalProductDefinition.name:Proprietary.productName
Definition | 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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
126. MedicinalProductDefinition.name:Proprietary.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 | 1..1
Binding | The codes SHALL be taken from Product Name Types Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C71898", "display" : "Proprietary Name" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
128. MedicinalProductDefinition.name:Proprietary.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
130. MedicinalProductDefinition.name:Proprietary.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
132. MedicinalProductDefinition.name:Proprietary.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()`)
134. MedicinalProductDefinition.name:Proprietary.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()`)
136. MedicinalProductDefinition.name:Proprietary.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
138. MedicinalProductDefinition.name:Proprietary.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 | The codes SHALL be taken from PQCMC Name Part Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
140. MedicinalProductDefinition.name:Proprietary.usage
Definition | 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())`)
142. MedicinalProductDefinition.name:Proprietary.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
144. MedicinalProductDefinition.name:Proprietary.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()`)
146. MedicinalProductDefinition.name:Proprietary.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()`)
148. MedicinalProductDefinition.name:Proprietary.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())`)
150. MedicinalProductDefinition.name:Proprietary.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())`)
152. MedicinalProductDefinition.name:Proprietary.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())`)
154. MedicinalProductDefinition.name:NonProprietary
Slice Name | NonProprietary
Definition | 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..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) cmc-strength-name-must-reference-scientific: strength parts must modify a scientific part, scientific parts must be modified by a strength part. The same scientific part cannot appear more than once (`defineVariable('system','http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2').select( defineVariable('strengthReferences',part.type.where(coding.exists(code = 'STR' and system = %system)).text).select( defineVariable('scientificNames',part.where(type.coding.exists(code = 'SCI' and system = %system)).part).select( %strengthReferences = %scientificNames and %scientificNames.distinct() = %scientificNames )))`)
156. MedicinalProductDefinition.name:NonProprietary.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
158. MedicinalProductDefinition.name:NonProprietary.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()`)
160. MedicinalProductDefinition.name:NonProprietary.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()`)
162. MedicinalProductDefinition.name:NonProprietary.productName
Definition | 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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
164. MedicinalProductDefinition.name:NonProprietary.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 | 1..1
Binding | The codes SHALL be taken from Product Name Types Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C96971", "display" : "Nonproprietary Name" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
166. MedicinalProductDefinition.name:NonProprietary.part
Definition | Name Parts are a means of specifying a range of acceptable forms of the name of a product. Note: The minimum is the scientific name.
Short | Coding words or phrases of the name
Control | 2..*
Type | BackboneElement
Is Modifier | false
Must Support | true
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.name.part`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type
168. MedicinalProductDefinition.name:NonProprietary.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
170. MedicinalProductDefinition.name:NonProprietary.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()`)
172. MedicinalProductDefinition.name:NonProprietary.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()`)
174. MedicinalProductDefinition.name:NonProprietary.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
176. MedicinalProductDefinition.name:NonProprietary.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 | The codes SHALL be taken from PQCMC Name Part Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
178. MedicinalProductDefinition.name:NonProprietary.part:Scientific
Slice Name | Scientific
Definition | Coding words or phrases of the name.
Short | Coding words or phrases of the name
Control | 1..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
180. MedicinalProductDefinition.name:NonProprietary.part:Scientific.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
182. MedicinalProductDefinition.name:NonProprietary.part:Scientific.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()`)
184. MedicinalProductDefinition.name:NonProprietary.part:Scientific.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()`)
186. MedicinalProductDefinition.name:NonProprietary.part:Scientific.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
188. MedicinalProductDefinition.name:NonProprietary.part:Scientific.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 | The codes SHALL be taken from PQCMC Name Part Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "SCI" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
190. MedicinalProductDefinition.name:NonProprietary.part:Invented
Slice Name | Invented
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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
192. MedicinalProductDefinition.name:NonProprietary.part:Invented.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
194. MedicinalProductDefinition.name:NonProprietary.part:Invented.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()`)
196. MedicinalProductDefinition.name:NonProprietary.part:Invented.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()`)
198. MedicinalProductDefinition.name:NonProprietary.part:Invented.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
200. MedicinalProductDefinition.name:NonProprietary.part:Invented.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 | The codes SHALL be taken from PQCMC Name Part Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "INV" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
202. MedicinalProductDefinition.name:NonProprietary.part:Formulation
Slice Name | Formulation
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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
204. MedicinalProductDefinition.name:NonProprietary.part:Formulation.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
206. MedicinalProductDefinition.name:NonProprietary.part:Formulation.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()`)
208. MedicinalProductDefinition.name:NonProprietary.part:Formulation.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()`)
210. MedicinalProductDefinition.name:NonProprietary.part:Formulation.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
212. MedicinalProductDefinition.name:NonProprietary.part:Formulation.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 | The codes SHALL be taken from PQCMC Name Part Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "FORMUL" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
214. MedicinalProductDefinition.name:NonProprietary.part:Strength
Slice Name | Strength
Definition | Coding words or phrases of the name.
Short | Coding words or phrases of the name
Control | 1..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
216. MedicinalProductDefinition.name:NonProprietary.part:Strength.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
218. MedicinalProductDefinition.name:NonProprietary.part:Strength.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()`)
220. MedicinalProductDefinition.name:NonProprietary.part:Strength.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()`)
222. MedicinalProductDefinition.name:NonProprietary.part:Strength.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
224. MedicinalProductDefinition.name:NonProprietary.part:Strength.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 | The codes SHALL be taken from PQCMC Name Part Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "STR" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
226. MedicinalProductDefinition.name:NonProprietary.part:Strength.type.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
228. MedicinalProductDefinition.name:NonProprietary.part:Strength.type.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.part.type.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
230. MedicinalProductDefinition.name:NonProprietary.part:Strength.type.coding
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..*
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())`)
232. MedicinalProductDefinition.name:NonProprietary.part:Strength.type.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 | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
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())`)
234. MedicinalProductDefinition.name:NonProprietary.part:Container
Slice Name | Container
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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
236. MedicinalProductDefinition.name:NonProprietary.part:Container.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
238. MedicinalProductDefinition.name:NonProprietary.part:Container.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()`)
240. MedicinalProductDefinition.name:NonProprietary.part:Container.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()`)
242. MedicinalProductDefinition.name:NonProprietary.part:Container.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
244. MedicinalProductDefinition.name:NonProprietary.part:Container.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 | The codes SHALL be taken from PQCMC Name Part Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "CON" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
246. MedicinalProductDefinition.name:NonProprietary.part:Form
Slice Name | Form
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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
248. MedicinalProductDefinition.name:NonProprietary.part:Form.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
250. MedicinalProductDefinition.name:NonProprietary.part:Form.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()`)
252. MedicinalProductDefinition.name:NonProprietary.part:Form.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()`)
254. MedicinalProductDefinition.name:NonProprietary.part:Form.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
256. MedicinalProductDefinition.name:NonProprietary.part:Form.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 | The codes SHALL be taken from PQCMC Name Part Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "FRM" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
258. MedicinalProductDefinition.name:NonProprietary.part:Device
Slice Name | Device
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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
260. MedicinalProductDefinition.name:NonProprietary.part:Device.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
262. MedicinalProductDefinition.name:NonProprietary.part:Device.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()`)
264. MedicinalProductDefinition.name:NonProprietary.part:Device.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()`)
266. MedicinalProductDefinition.name:NonProprietary.part:Device.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 | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
268. MedicinalProductDefinition.name:NonProprietary.part:Device.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 | The codes SHALL be taken from PQCMC Name Part Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Pattern Value | `{ "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2", "code" : "DEV" }] }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
270. MedicinalProductDefinition.name:NonProprietary.usage
Definition | 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())`)
272. MedicinalProductDefinition.name:NonProprietary.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
274. MedicinalProductDefinition.name:NonProprietary.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()`)
276. MedicinalProductDefinition.name:NonProprietary.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()`)
278. MedicinalProductDefinition.name:NonProprietary.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())`)
280. MedicinalProductDefinition.name:NonProprietary.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())`)
282. MedicinalProductDefinition.name:NonProprietary.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())`)
284. 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())`)
286. 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
288. 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()`)
290. 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()`)
292. 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())`)
294. 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())`)
296. 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())`)
298. 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
300. 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()`)
302. 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()`)
304. 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())`)
306. 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())`)
308. 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())`)
310. 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())`)
312. 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())`)
314. 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
316. 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()`)
318. 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()`)
320. 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())`)
322. 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())`)