Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot International flag

This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR v5.0.0-ballot. . For a full list of available versions, see the Directory of published versions

Resource Profile: MedicinalProductDefinitionUvEpi - Detailed Descriptions

Active as of 2022-12-04

Definitions for the MedicinalProductDefinition-uv-epi resource profile.

Guidance on how to interpret the contents of this table can be found here.

1. MedicinalProductDefinition
2. MedicinalProductDefinition.identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control10..*
3. MedicinalProductDefinition.identifier.system
Control1..?
BindingThe codes SHALL be taken from MedicinalProductDefinition identifier systems; other codes may be used where these codes are not suitable
4. MedicinalProductDefinition.identifier.value
Control1..?
5. MedicinalProductDefinition.type
BindingThe codes SHOULD be taken from Medicinal Product TypeFor example codes, see MedicinalProductType
6. MedicinalProductDefinition.domain
BindingThe codes SHOULD be taken from MedicinalProductDomainFor example codes, see MedicinalProductDomain
7. MedicinalProductDefinition.version
NoteThis is a business versionId, not a resource version id (see discussion)
8. MedicinalProductDefinition.status
9. MedicinalProductDefinition.statusDate
10. MedicinalProductDefinition.description
11. MedicinalProductDefinition.combinedPharmaceuticalDoseForm
BindingThe codes SHOULD be taken from Combined Pharmaceutical Dose FormFor example codes, see CombinedDoseForm
12. MedicinalProductDefinition.route
BindingThe codes SHOULD be taken from Route Of AdministrationFor example codes, see SNOMEDCTRouteCodes
13. MedicinalProductDefinition.indication
14. MedicinalProductDefinition.legalStatusOfSupply
BindingThe codes SHOULD be taken from Legal Status for the SupplyFor example codes, see LegalStatusOfSupply
15. MedicinalProductDefinition.additionalMonitoringIndicator
BindingThe codes SHOULD be taken from Additional Monitoring IndicatorFor example codes, see AdditionalMonitoring
16. MedicinalProductDefinition.pediatricUseIndicator
BindingThe codes SHOULD be taken from Pediatric Use IndicatorFor example codes, see PediatricUse
17. MedicinalProductDefinition.classification
BindingThe codes SHOULD be taken from WHO ATCFor example codes, see ProductClassification
18. MedicinalProductDefinition.marketingStatus
19. MedicinalProductDefinition.marketingStatus.status
Control0..?
BindingThe codes SHOULD be taken from Marketing Status
20. MedicinalProductDefinition.packagedMedicinalProduct
BindingThe codes SHOULD be taken from High level Pack TypeFor example codes, see MedicinalProductPackageType
21. MedicinalProductDefinition.name
Control0..?
22. MedicinalProductDefinition.name.productName
Example
general:Humalog Mix50 Insulin KwikPen, 3 ml pre-fill
23. MedicinalProductDefinition.name.type
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="https://spor.ema.europa.eu/rmswi/220000000000"/>
    <code value="220000000001"/>
  </coding>
</valueCodeableConcept>
24. MedicinalProductDefinition.name.part
SlicingThis element introduces a set of slices on MedicinalProductDefinition.name.part. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ type
25. MedicinalProductDefinition.name.part:ProprietaryNamePart
SliceNameProprietaryNamePart
Control0..*
26. MedicinalProductDefinition.name.part:ProprietaryNamePart.part
Control0..?
Example
Example brand name:Humalog Mix50
27. MedicinalProductDefinition.name.part:ProprietaryNamePart.type
Control0..?
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="https://spor.ema.europa.eu/rmswi/220000000000"/>
    <code value="220000000002"/>
  </coding>
</valueCodeableConcept>
28. MedicinalProductDefinition.name.part:Non-proprietaryNamePart
SliceNameNon-proprietaryNamePart
Control0..*
29. MedicinalProductDefinition.name.part:Non-proprietaryNamePart.part
Control0..?
Example
Example INN:Insulin lispro
30. MedicinalProductDefinition.name.part:Non-proprietaryNamePart.type
Control0..?
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="https://spor.ema.europa.eu/rmswi/220000000000"/>
    <code value="220000000003"/>
  </coding>
</valueCodeableConcept>
31. MedicinalProductDefinition.name.part:StrengthPart
SliceNameStrengthPart
Control0..*
32. MedicinalProductDefinition.name.part:StrengthPart.part
Control0..?
Example
Example quantity:100 units/ml
33. MedicinalProductDefinition.name.part:StrengthPart.type
Control0..?
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="https://spor.ema.europa.eu/rmswi/220000000000"/>
    <code value="220000000004"/>
  </coding>
</valueCodeableConcept>
34. MedicinalProductDefinition.name.part:PharmaceuticalDoseFormPart
SliceNamePharmaceuticalDoseFormPart
Control0..*
35. MedicinalProductDefinition.name.part:PharmaceuticalDoseFormPart.part
Control0..?
Example
Example dose form:solution for injection
36. MedicinalProductDefinition.name.part:PharmaceuticalDoseFormPart.type
Control0..?
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="https://spor.ema.europa.eu/rmswi/220000000000"/>
    <code value="220000000005"/>
  </coding>
</valueCodeableConcept>
37. MedicinalProductDefinition.name.usage
Control0..?
38. MedicinalProductDefinition.name.usage.country
BindingThe codes SHOULD be taken from ISO Country two letter codeFor example codes, see Country ValueSet
39. MedicinalProductDefinition.name.usage.jurisdiction
BindingThe codes SHOULD be taken from ISO Country two letter codeFor example codes, see Jurisdiction ValueSet
40. MedicinalProductDefinition.crossReference
Control0..?
41. MedicinalProductDefinition.crossReference.type
BindingThe codes SHALL be taken from ProductCrossReferenceType; other codes may be used where these codes are not suitableFor example codes, see ProductCrossReferenceType
42. MedicinalProductDefinition.operation
Control0..?
43. MedicinalProductDefinition.operation.type
BindingThe codes SHOULD be taken from Type of operationFor codes, see (unbound)
44. MedicinalProductDefinition.operation.type.concept
Control1..?
45. MedicinalProductDefinition.operation.organization
TypeReference(OrganizationUvEpi|Organization)

Guidance on how to interpret the contents of this table can be found here.

1. 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).

Control0..*
InvariantsDefined on this element
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(as(canonical) = '#').exists() or descendants().where(as(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.

Control0..1
Typeuri
Is Modifiertrue
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
3. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
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())
4. 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.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control10..*
TypeIdentifier
Alternate NamesMPID
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
5. MedicinalProductDefinition.identifier.use
Definition

The purpose of this identifier.

Control0..1
BindingThe codes SHALL be taken from IdentifierUse
Typecode
Is Modifiertrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
6. MedicinalProductDefinition.identifier.system
Definition

Establishes the namespace for the value - that is, a absolute URL that describes a set values that are unique.

Control10..1
BindingThe codes SHALL be taken from MedicinalProductDefinition identifier systems; other codes may be used where these codes are not suitableFor codes, see (unbound)
Typeuri
Requirements

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

Comments

Identifier.system is always case sensitive.

Example
General:http://www.acme.com/identifiers/patient
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
7. MedicinalProductDefinition.identifier.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

Control10..1
Typestring
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

Example
General:123456
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
8. MedicinalProductDefinition.type
Definition

Regulatory type, e.g. Investigational or Authorized.

Control0..1
BindingThe codes SHOULD be taken from Medicinal Product TypeFor example codes, see MedicinalProductType
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
9. MedicinalProductDefinition.domain
Definition

If this medicine applies to human or veterinary uses.

Control0..1
BindingThe codes SHOULD be taken from MedicinalProductDomainFor example codes, see MedicinalProductDomain
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
10. 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.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1
Typestring
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
11. 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.

Control0..1
BindingThe codes SHOULD be taken from PublicationStatus
TypeCodeableConcept
Is Modifiertrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
12. MedicinalProductDefinition.statusDate
Definition

The date at which the given status became applicable.

Control0..1
TypedateTime
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
13. MedicinalProductDefinition.description
Definition

General description of this product.

Control0..1
Typemarkdown
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
14. MedicinalProductDefinition.combinedPharmaceuticalDoseForm
Definition

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).

Control0..1
BindingThe codes SHOULD be taken from Combined Pharmaceutical Dose FormFor example codes, see CombinedDoseForm
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
15. MedicinalProductDefinition.route
Definition

The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route. See also AdministrableProductDefinition resource. MedicinalProductDefinition.route is the same concept as AdministrableProductDefinition.routeOfAdministration.code, and they cannot be used together.

Control0..*
BindingThe codes SHOULD be taken from Route Of AdministrationFor example codes, see SNOMEDCTRouteCodes
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
16. 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.

Control0..1
Typemarkdown
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
17. MedicinalProductDefinition.legalStatusOfSupply
Definition

The legal status of supply of the medicinal product as classified by the regulator.

Control0..1
BindingThe codes SHOULD be taken from Legal Status for the SupplyFor example codes, see LegalStatusOfSupply
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
18. MedicinalProductDefinition.additionalMonitoringIndicator
Definition

Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirements.

Control0..1
BindingThe codes SHOULD be taken from Additional Monitoring IndicatorFor example codes, see AdditionalMonitoring
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
19. MedicinalProductDefinition.pediatricUseIndicator
Definition

If authorised for use in children, or infants, neonates etc.

Control0..1
BindingThe codes SHOULD be taken from Pediatric Use IndicatorFor example codes, see PediatricUse
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
20. MedicinalProductDefinition.classification
Definition

Allows the product to be classified by various systems, commonly WHO ATC.

Control0..*
BindingThe codes SHOULD be taken from WHO ATCFor example codes, see ProductClassification
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
21. 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).

Control0..*
TypeMarketingStatus
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
22. MedicinalProductDefinition.marketingStatus.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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())
23. MedicinalProductDefinition.marketingStatus.status
Definition

This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples.

Control1..1
BindingThe codes SHOULD be taken from Marketing StatusFor codes, see (unbound)
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
24. MedicinalProductDefinition.packagedMedicinalProduct
Definition

Package type for the product. See also the PackagedProductDefinition resource.

Control0..*
BindingThe codes SHOULD be taken from High level Pack TypeFor example codes, see MedicinalProductPackageType
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
25. MedicinalProductDefinition.name
Definition

The product's name, including full name and possibly coded parts.

Control1..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
26. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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())
27. MedicinalProductDefinition.name.productName
Definition

The full product name.

Control1..1
Typestring
Example
general:Humalog Mix50 Insulin KwikPen, 3 ml pre-fill
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
28. MedicinalProductDefinition.name.type
Definition

Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.

Control0..1
BindingFor example codes, see ProductNameType

Type of a name for a Medicinal Product.

TypeCodeableConcept
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="https://spor.ema.europa.eu/rmswi/220000000000"/>
    <code value="220000000001"/>
  </coding>
</valueCodeableConcept>
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
29. MedicinalProductDefinition.name.part
Definition

Coding words or phrases of the name.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on MedicinalProductDefinition.name.part. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ type
30. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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())
31. MedicinalProductDefinition.name.part.part
Definition

A fragment of a product name.

Control1..1
Typestring
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
32. MedicinalProductDefinition.name.part.type
Definition

Identifying type for this part of the name (e.g. strength part).

Control1..1
BindingFor example codes, see ProductNamePartType

Type of part of a name for a Medicinal Product.

TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
33. MedicinalProductDefinition.name.part:ProprietaryNamePart
SliceNameProprietaryNamePart
Definition

Coding words or phrases of the name.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
34. MedicinalProductDefinition.name.part:ProprietaryNamePart.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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())
35. MedicinalProductDefinition.name.part:ProprietaryNamePart.part
Definition

A fragment of a product name.

Control1..1
Typestring
Example
Example brand name:Humalog Mix50
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
36. MedicinalProductDefinition.name.part:ProprietaryNamePart.type
Definition

Identifying type for this part of the name (e.g. strength part).

Control1..1
BindingFor example codes, see ProductNamePartType

Type of part of a name for a Medicinal Product.

TypeCodeableConcept
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="https://spor.ema.europa.eu/rmswi/220000000000"/>
    <code value="220000000002"/>
  </coding>
</valueCodeableConcept>
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
37. MedicinalProductDefinition.name.part:Non-proprietaryNamePart
SliceNameNon-proprietaryNamePart
Definition

Coding words or phrases of the name.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
38. MedicinalProductDefinition.name.part:Non-proprietaryNamePart.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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())
39. MedicinalProductDefinition.name.part:Non-proprietaryNamePart.part
Definition

A fragment of a product name.

Control1..1
Typestring
Example
Example INN:Insulin lispro
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
40. MedicinalProductDefinition.name.part:Non-proprietaryNamePart.type
Definition

Identifying type for this part of the name (e.g. strength part).

Control1..1
BindingFor example codes, see ProductNamePartType

Type of part of a name for a Medicinal Product.

TypeCodeableConcept
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="https://spor.ema.europa.eu/rmswi/220000000000"/>
    <code value="220000000003"/>
  </coding>
</valueCodeableConcept>
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
41. MedicinalProductDefinition.name.part:StrengthPart
SliceNameStrengthPart
Definition

Coding words or phrases of the name.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
42. MedicinalProductDefinition.name.part:StrengthPart.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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())
43. MedicinalProductDefinition.name.part:StrengthPart.part
Definition

A fragment of a product name.

Control1..1
Typestring
Example
Example quantity:100 units/ml
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
44. MedicinalProductDefinition.name.part:StrengthPart.type
Definition

Identifying type for this part of the name (e.g. strength part).

Control1..1
BindingFor example codes, see ProductNamePartType

Type of part of a name for a Medicinal Product.

TypeCodeableConcept
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="https://spor.ema.europa.eu/rmswi/220000000000"/>
    <code value="220000000004"/>
  </coding>
</valueCodeableConcept>
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
45. MedicinalProductDefinition.name.part:PharmaceuticalDoseFormPart
SliceNamePharmaceuticalDoseFormPart
Definition

Coding words or phrases of the name.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
46. MedicinalProductDefinition.name.part:PharmaceuticalDoseFormPart.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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())
47. MedicinalProductDefinition.name.part:PharmaceuticalDoseFormPart.part
Definition

A fragment of a product name.

Control1..1
Typestring
Example
Example dose form:solution for injection
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
48. MedicinalProductDefinition.name.part:PharmaceuticalDoseFormPart.type
Definition

Identifying type for this part of the name (e.g. strength part).

Control1..1
BindingFor example codes, see ProductNamePartType

Type of part of a name for a Medicinal Product.

TypeCodeableConcept
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="https://spor.ema.europa.eu/rmswi/220000000000"/>
    <code value="220000000005"/>
  </coding>
</valueCodeableConcept>
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be found here.

1. 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).

Control0..*
2. MedicinalProductDefinition.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Control0..1
Typeid
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.

3. 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.

Control0..1
TypeMeta
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
4. 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.

Control0..1
Typeuri
Is Modifiertrue
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
5. MedicinalProductDefinition.language
Definition

The base language in which the resource is written.

Control0..1
BindingThe codes SHOULD be taken from CommonLanguages IETF language ta
Additional BindingsPurpose
AllLanguagesMax Binding
Typecode
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).

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
6. 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.

Control0..1
TypeNarrative
Alternate Namesnarrative, html, xhtml, display
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
7. 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.

Control0..*
TypeResource
Alternate Namesinline resources, anonymous resources, contained resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

8. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
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())
9. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
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())
10. 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.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control1..*
TypeIdentifier
Alternate NamesMPID
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
11. MedicinalProductDefinition.identifier.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typeid
XML RepresentationIn the XML format, this property is represented as an attribute.
12. MedicinalProductDefinition.identifier.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
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())
SlicingThis element introduces a set of slices on MedicinalProductDefinition.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
13. MedicinalProductDefinition.identifier.use
Definition

The purpose of this identifier.

Control0..1
BindingThe codes SHALL be taken from IdentifierUse
Typecode
Is Modifiertrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
14. MedicinalProductDefinition.identifier.type
Definition

A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

Control0..1
BindingThe codes SHALL be taken from Identifier Type Codes; other codes may be used where these codes are not suitable
TypeCodeableConcept
Requirements

Allows users to make use of identifiers when the identifier system is not known.

Comments

This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
15. MedicinalProductDefinition.identifier.system
Definition

Establishes the namespace for the value - that is, a absolute URL that describes a set values that are unique.

Control1..1
BindingThe codes SHALL be taken from MedicinalProductDefinition identifier systems; other codes may be used where these codes are not suitable
Typeuri
Requirements

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

Comments

Identifier.system is always case sensitive.

Example
General:http://www.acme.com/identifiers/patient
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
16. MedicinalProductDefinition.identifier.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

Control1..1
Typestring
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

Example
General:123456
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
17. MedicinalProductDefinition.identifier.period
Definition

Time period during which identifier is/was valid for use.

Control0..1
TypePeriod
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
18. MedicinalProductDefinition.identifier.assigner
Definition

Organization that issued/manages the identifier.

Control0..1
TypeReference(Organization)
Comments

The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
19. MedicinalProductDefinition.type
Definition

Regulatory type, e.g. Investigational or Authorized.

Control0..1
BindingThe codes SHOULD be taken from Medicinal Product Type
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
20. MedicinalProductDefinition.domain
Definition

If this medicine applies to human or veterinary uses.

Control0..1
BindingThe codes SHOULD be taken from MedicinalProductDomain
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
21. 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.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1
Typestring
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
22. 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.

Control0..1
BindingThe codes SHOULD be taken from PublicationStatus
TypeCodeableConcept
Is Modifiertrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
23. MedicinalProductDefinition.statusDate
Definition

The date at which the given status became applicable.

Control0..1
TypedateTime
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
24. MedicinalProductDefinition.description
Definition

General description of this product.

Control0..1
Typemarkdown
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
25. MedicinalProductDefinition.combinedPharmaceuticalDoseForm
Definition

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).

Control0..1
BindingThe codes SHOULD be taken from Combined Pharmaceutical Dose Form
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
26. MedicinalProductDefinition.route
Definition

The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route. See also AdministrableProductDefinition resource. MedicinalProductDefinition.route is the same concept as AdministrableProductDefinition.routeOfAdministration.code, and they cannot be used together.

Control0..*
BindingThe codes SHOULD be taken from Route Of Administration
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
27. 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.

Control0..1
Typemarkdown
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
28. MedicinalProductDefinition.legalStatusOfSupply
Definition

The legal status of supply of the medicinal product as classified by the regulator.

Control0..1
BindingThe codes SHOULD be taken from Legal Status for the Supply
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
29. MedicinalProductDefinition.additionalMonitoringIndicator
Definition

Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirements.

Control0..1
BindingThe codes SHOULD be taken from Additional Monitoring Indicator
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
30. MedicinalProductDefinition.specialMeasures
Definition

Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorisation studies.

Control0..*
BindingFor example codes, see SpecialMeasures Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorisation studies
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
31. MedicinalProductDefinition.pediatricUseIndicator
Definition

If authorised for use in children, or infants, neonates etc.

Control0..1
BindingThe codes SHOULD be taken from Pediatric Use Indicator
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
32. MedicinalProductDefinition.classification
Definition

Allows the product to be classified by various systems, commonly WHO ATC.

Control0..*
BindingThe codes SHOULD be taken from WHO ATC
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
33. 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).

Control0..*
TypeMarketingStatus
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
34. MedicinalProductDefinition.marketingStatus.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typeid
XML RepresentationIn the XML format, this property is represented as an attribute.
35. MedicinalProductDefinition.marketingStatus.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
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())
SlicingThis element introduces a set of slices on MedicinalProductDefinition.marketingStatus.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
36. MedicinalProductDefinition.marketingStatus.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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())
37. MedicinalProductDefinition.marketingStatus.country
Definition

The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements.

Control0..1
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
38. MedicinalProductDefinition.marketingStatus.jurisdiction
Definition

Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified.

Control0..1
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
39. MedicinalProductDefinition.marketingStatus.status
Definition

This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples.

Control1..1
BindingThe codes SHOULD be taken from Marketing Status
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
40. MedicinalProductDefinition.marketingStatus.dateRange
Definition

The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain.

Control0..1
TypePeriod
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
41. MedicinalProductDefinition.marketingStatus.restoreDate
Definition

The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain.

Control0..1
TypedateTime
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
42. MedicinalProductDefinition.packagedMedicinalProduct
Definition

Package type for the product. See also the PackagedProductDefinition resource.

Control0..*
BindingThe codes SHOULD be taken from High level Pack Type
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
43. 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).

Control0..*
TypeReference(ManufacturedItemDefinition|DeviceDefinition)
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
44. 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.

Control0..*
BindingFor example codes, see SNOMEDCTSubstanceCodes This value set includes all substance codes from SNOMED CT - provided as an exemplar value set
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
45. 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.

Control0..*
BindingFor example codes, see SNOMEDCTSubstanceCodes This value set includes all substance codes from SNOMED CT - provided as an exemplar value set
TypeCodeableReference(SubstanceDefinition)
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
46. MedicinalProductDefinition.attachedDocument
Definition

Additional information or supporting documentation about the medicinal product.

Control0..*
TypeReference(DocumentReference)
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
47. 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.

Control0..*
TypeReference(DocumentReference)
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
48. MedicinalProductDefinition.contact
Definition

A product specific contact, person (in a role), or an organization.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
49. 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.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
50. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
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())
51. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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())
52. MedicinalProductDefinition.contact.type
Definition

Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.

Control0..1
BindingFor example codes, see ProductContactType Extra measures defined for a Medicinal Product, such as heightened reporting requirements
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
53. MedicinalProductDefinition.contact.contact
Definition

A product specific contact, person (in a role), or an organization.

Control1..1
TypeReference(Organization|PractitionerRole)
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
54. MedicinalProductDefinition.clinicalTrial
Definition

Clinical trials or studies that this product is involved in.

Control0..*
TypeReference(ResearchStudy)
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
55. 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.

Control0..*
BindingFor example codes, see SNOMEDCTMedicationCodes A coded concept that defines the type of a medication
TypeCoding
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
56. MedicinalProductDefinition.name
Definition

The product's name, including full name and possibly coded parts.

Control1..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
57. 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.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
58. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
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())
59. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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())
60. MedicinalProductDefinition.name.productName
Definition

The full product name.

Control1..1
Typestring
Example
general:Humalog Mix50 Insulin KwikPen, 3 ml pre-fill
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
61. MedicinalProductDefinition.name.type
Definition

Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.

Control0..1
BindingFor example codes, see ProductNameType Type of a name for a Medicinal Product
TypeCodeableConcept
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="https://spor.ema.europa.eu/rmswi/220000000000"/>
    <code value="220000000001"/>
  </coding>
</valueCodeableConcept>
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
62. MedicinalProductDefinition.name.part
Definition

Coding words or phrases of the name.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on MedicinalProductDefinition.name.part. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ type
63. 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.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
64. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
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())
65. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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())
66. MedicinalProductDefinition.name.part.part
Definition

A fragment of a product name.

Control1..1
Typestring
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
67. MedicinalProductDefinition.name.part.type
Definition

Identifying type for this part of the name (e.g. strength part).

Control1..1
BindingFor example codes, see ProductNamePartType Type of part of a name for a Medicinal Product
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
68. MedicinalProductDefinition.name.part:ProprietaryNamePart
SliceNameProprietaryNamePart
Definition

Coding words or phrases of the name.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
69. MedicinalProductDefinition.name.part:ProprietaryNamePart.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
70. MedicinalProductDefinition.name.part:ProprietaryNamePart.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
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())
71. MedicinalProductDefinition.name.part:ProprietaryNamePart.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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())
72. MedicinalProductDefinition.name.part:ProprietaryNamePart.part
Definition

A fragment of a product name.

Control1..1
Typestring
Example
Example brand name:Humalog Mix50
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
73. MedicinalProductDefinition.name.part:ProprietaryNamePart.type
Definition

Identifying type for this part of the name (e.g. strength part).

Control1..1
BindingFor example codes, see ProductNamePartType Type of part of a name for a Medicinal Product
TypeCodeableConcept
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="https://spor.ema.europa.eu/rmswi/220000000000"/>
    <code value="220000000002"/>
  </coding>
</valueCodeableConcept>
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
74. MedicinalProductDefinition.name.part:Non-proprietaryNamePart
SliceNameNon-proprietaryNamePart
Definition

Coding words or phrases of the name.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
75. MedicinalProductDefinition.name.part:Non-proprietaryNamePart.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
76. MedicinalProductDefinition.name.part:Non-proprietaryNamePart.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
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())
77. MedicinalProductDefinition.name.part:Non-proprietaryNamePart.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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.part:Non-proprietaryNamePart.part
Definition

A fragment of a product name.

Control1..1
Typestring
Example
Example INN:Insulin lispro
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
79. MedicinalProductDefinition.name.part:Non-proprietaryNamePart.type
Definition

Identifying type for this part of the name (e.g. strength part).

Control1..1
BindingFor example codes, see ProductNamePartType Type of part of a name for a Medicinal Product
TypeCodeableConcept
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="https://spor.ema.europa.eu/rmswi/220000000000"/>
    <code value="220000000003"/>
  </coding>
</valueCodeableConcept>
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
80. MedicinalProductDefinition.name.part:StrengthPart
SliceNameStrengthPart
Definition

Coding words or phrases of the name.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
81. MedicinalProductDefinition.name.part:StrengthPart.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
82. MedicinalProductDefinition.name.part:StrengthPart.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
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())
83. MedicinalProductDefinition.name.part:StrengthPart.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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.part:StrengthPart.part
Definition

A fragment of a product name.

Control1..1
Typestring
Example
Example quantity:100 units/ml
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
85. MedicinalProductDefinition.name.part:StrengthPart.type
Definition

Identifying type for this part of the name (e.g. strength part).

Control1..1
BindingFor example codes, see ProductNamePartType Type of part of a name for a Medicinal Product
TypeCodeableConcept
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="https://spor.ema.europa.eu/rmswi/220000000000"/>
    <code value="220000000004"/>
  </coding>
</valueCodeableConcept>
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
86. MedicinalProductDefinition.name.part:PharmaceuticalDoseFormPart
SliceNamePharmaceuticalDoseFormPart
Definition

Coding words or phrases of the name.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
87. MedicinalProductDefinition.name.part:PharmaceuticalDoseFormPart.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
88. MedicinalProductDefinition.name.part:PharmaceuticalDoseFormPart.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
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())
89. MedicinalProductDefinition.name.part:PharmaceuticalDoseFormPart.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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())
90. MedicinalProductDefinition.name.part:PharmaceuticalDoseFormPart.part
Definition

A fragment of a product name.

Control1..1
Typestring
Example
Example dose form:solution for injection
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
91. MedicinalProductDefinition.name.part:PharmaceuticalDoseFormPart.type
Definition

Identifying type for this part of the name (e.g. strength part).

Control1..1
BindingFor example codes, see ProductNamePartType Type of part of a name for a Medicinal Product
TypeCodeableConcept
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="https://spor.ema.europa.eu/rmswi/220000000000"/>
    <code value="220000000005"/>
  </coding>
</valueCodeableConcept>
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
92. MedicinalProductDefinition.name.usage
Definition

Country and jurisdiction where the name applies, and associated language.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
93. 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.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
94. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
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())
95. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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.usage.country
Definition

Country code for where this name applies.

Control1..1
BindingThe codes SHOULD be taken from ISO Country two letter code
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
97. 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).

Control0..1
BindingThe codes SHOULD be taken from ISO Country two letter code
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
98. MedicinalProductDefinition.name.usage.language
Definition

Language code for this name.

Control1..1
BindingThe codes SHOULD be taken from CommonLanguages IETF language ta
Additional BindingsPurpose
AllLanguagesMax Binding
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
99. MedicinalProductDefinition.crossReference
Definition

Reference to another product, e.g. for linking authorised to investigational product, or a virtual product.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
100. 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.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
101. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
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())
102. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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())
103. MedicinalProductDefinition.crossReference.product
Definition

Reference to another product, e.g. for linking authorised to investigational product.

Control1..1
TypeCodeableReference(MedicinalProductDefinition)
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
104. 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.

Control0..1
BindingThe codes SHALL be taken from ProductCrossReferenceType; other codes may be used where these codes are not suitable
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
105. MedicinalProductDefinition.operation
Definition

A manufacturing or administrative process or step associated with (or performed on) the medicinal product.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
106. 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.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
107. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
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.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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())
109. 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.

Control0..1
BindingThe codes SHOULD be taken from Type of operation
TypeCodeableReference(ActivityDefinition|PlanDefinition)
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
110. MedicinalProductDefinition.operation.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.

Control0..1
Typeid
XML RepresentationIn the XML format, this property is represented as an attribute.
111. MedicinalProductDefinition.operation.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
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())
SlicingThis element introduces a set of slices on MedicinalProductDefinition.operation.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
112. MedicinalProductDefinition.operation.type.concept
Definition

A reference to a concept - e.g. the information is identified by its general class to the degree of precision found in the terminology.

Control1..1
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
113. MedicinalProductDefinition.operation.type.reference
Definition

A reference to a resource the provides exact details about the information being referenced.

Control0..1
TypeReference
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
114. MedicinalProductDefinition.operation.effectiveDate
Definition

Date range of applicability.

Control0..1
TypePeriod
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
115. MedicinalProductDefinition.operation.organization
Definition

The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent.

Control0..*
TypeReference(OrganizationUvEpi)
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
116. MedicinalProductDefinition.operation.confidentialityIndicator
Definition

Specifies whether this particular business or manufacturing process is considered proprietary or confidential.

Control0..1
BindingFor example codes, see ProductConfidentiality Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
117. MedicinalProductDefinition.characteristic
Definition

Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import".

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
118. 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.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
119. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
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())
120. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content, modifiers
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.

InvariantsDefined on this element
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())
121. MedicinalProductDefinition.characteristic.type
Definition

A code expressing the type of characteristic.

Control1..1
BindingFor example codes, see ProductCharacteristic This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set
TypeCodeableConcept
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
122. MedicinalProductDefinition.characteristic.value[x]
Definition

A value for the characteristic.text.

Control0..1
TypeChoice of: CodeableConcept, string, Quantity, integer, date, boolean, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Comments

String 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. (temporary text to make build work: The usage of CodeableConcept is for concepts that are normally coded but for which a code is not available - for example a device implant size that is not standardized. The property string is for text characteristics, e.g. long descriptions, warnings, etc.).

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))