Vulcan ePI FHIR Implementation Guide
0.1.0 - CI Build

Vulcan ePI FHIR Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions

Resource Profile: MedicinalProductDefinition (ePI)

Official URL: http://hl7.org/fhir/uv/vulcan-epi/StructureDefinition/MedicinalProductDefinition-uv-epi Version: 0.1.0
Active as of 2022-09-02 Computable Name: MedicinalProductDefinitionUvEpi

MedicinalProductDefinition (ePI)

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from MedicinalProductDefinition

Summary

Mandatory: 3 elements (2 nested mandatory elements)

This structure is derived from MedicinalProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..*MedicinalProductDefinitionDetailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use, drug catalogs)
... identifier 1..*IdentifierBusiness identifier for this product. Could be an MPID
.... system 1..1uriThe namespace for the identifier value
Binding: MedicinalProductDefinition identifier systems (extensible)
.... value 1..1stringThe value that is unique
... type 0..1CodeableConceptRegulatory type, e.g. Investigational or Authorized
Binding: MedicinalProductType (extensible)
... domain 0..1CodeableConceptIf this medicine applies to human or veterinary uses
Binding: MedicinalProductDomain (extensible)
.... coding 1..*CodingCode defined by a terminology system
... status 0..1CodeableConceptThe 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
Binding: PublicationStatus (extensible)
... statusDate 0..1dateTimeThe date at which this status became applicable.
... description 0..1markdownGeneral description of the product referred by the ePI
... combinedPharmaceuticalDoseForm 0..1CodeableConceptThe dose form for a single part product or combined form of a multiple part product
... route 0..*CodeableConceptRoute of administration
... indication 0..1markdownDescription of indication(s) for this product, used when structured indications are not required.
... legalStatusOfSupply 0..1CodeableConceptThe legal status of supply of the medicinal product as classified by the regulator
Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"100000072084","display":"Medicinal product subject to medical prescription"}]}
.... coding 1..*CodingCode defined by a terminology system
... additionalMonitoringIndicator 0..1CodeableConceptAdditional monitoring this Medicinal Product is subject to (for regulatory reasons)
... pediatricUseIndicator 0..1CodeableConceptAuthorised pediatric use
... classification 0..*CodeableConceptClassifications used for this product
... marketingStatus 0..*MarketingStatusMarketing status of the medicinal product in contrast to marketing authorization
... packagedMedicinalProduct 0..*CodeableConceptPackage type for this product
... name
.... productName 1..1stringThe full name of this product
Example general: Humalog Mix50 Insulin KwikPen, 3ml pre-fill
.... type 0..1CodeableConceptType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"220000000001","display":"Full name"}]}
.... namePart
..... part 1..1stringA fragment of a product name
Example general: Humalog
..... type 1..1CodeableConceptIdentifying type for this part of the name (e.g. strength part)
Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"220000000002","display":"Invented name part"}]}
.... countryLanguage
..... country 1..1CodeableConceptCountry for where this name applies (code)
..... language 1..1CodeableConceptLanguage for this name (code)

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..*MedicinalProductDefinitionDetailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use, drug catalogs)
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): IETF language tag

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ1..*IdentifierBusiness identifier for this product. Could be an MPID
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required)
.... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible)
.... system Σ1..1uriThe namespace for the identifier value
Binding: MedicinalProductDefinition identifier systems (extensible)
Example General: http://www.acme.com/identifiers/patient
.... value Σ1..1stringThe value that is unique
Example General: 123456
.... period Σ0..1PeriodTime period when id is/was valid for use
.... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
... type Σ0..1CodeableConceptRegulatory type, e.g. Investigational or Authorized
Binding: MedicinalProductType (extensible)
... domain Σ0..1CodeableConceptIf this medicine applies to human or veterinary uses
Binding: MedicinalProductDomain (extensible)
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ1..*CodingCode defined by a terminology system
.... text Σ0..1stringPlain text representation of the concept
... version Σ0..1stringBusiness version of this product
... status ?!Σ0..1CodeableConceptThe 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
Binding: PublicationStatus (extensible)
... statusDate Σ0..1dateTimeThe date at which this status became applicable.
... description Σ0..1markdownGeneral description of the product referred by the ePI
... combinedPharmaceuticalDoseForm Σ0..1CodeableConceptThe dose form for a single part product or combined form of a multiple part product
Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing

... route Σ0..*CodeableConceptRoute of administration
Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.


... indication Σ0..1markdownDescription of indication(s) for this product, used when structured indications are not required.
... legalStatusOfSupply Σ0..1CodeableConceptThe legal status of supply of the medicinal product as classified by the regulator
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product


Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"100000072084","display":"Medicinal product subject to medical prescription"}]}
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ1..*CodingCode defined by a terminology system
.... text Σ0..1stringPlain text representation of the concept
... additionalMonitoringIndicator Σ0..1CodeableConceptAdditional monitoring this Medicinal Product is subject to (for regulatory reasons)
... specialMeasures Σ0..*CodeableConceptWhether the Medicinal Product is subject to special measures for regulatory reasons
... pediatricUseIndicator Σ0..1CodeableConceptAuthorised pediatric use
... classification Σ0..*CodeableConceptClassifications used for this product
... marketingStatus Σ0..*MarketingStatusMarketing status of the medicinal product in contrast to marketing authorization
... packagedMedicinalProduct Σ0..*CodeableConceptPackage type for this product
Binding: MedicinalProductPackageType (example): Types of medicinal product packs


... ingredient Σ0..*CodeableConceptThe 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
... impurity Σ0..*CodeableReference(SubstanceDefinition)Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products
... attachedDocument Σ0..*Reference(DocumentReference)Additional information or supporting documentation about the medicinal product
... masterFile Σ0..*Reference(DocumentReference)A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
... contact Σ0..*BackboneElementA product specific contact, person (in a role), or an organization
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ0..1CodeableConceptAllows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
.... contact Σ1..1Reference(Organization | PractitionerRole)A product specific contact, person (in a role), or an organization
... clinicalTrial Σ0..*Reference(ResearchStudy)Clinical trials or studies that this product is involved in
... code Σ0..*CodingA code that this product is known by, within some formal terminology
Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.


... name Σ1..*BackboneElementThe product's name, including full name and possibly coded parts
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... productName Σ1..1stringThe full name of this product
Example general: Humalog Mix50 Insulin KwikPen, 3ml pre-fill
.... type Σ0..1CodeableConceptType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"220000000001","display":"Full name"}]}
.... namePart Σ0..*BackboneElementCoding words or phrases of the name
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... part Σ1..1stringA fragment of a product name
Example general: Humalog
..... type Σ1..1CodeableConceptIdentifying type for this part of the name (e.g. strength part)
Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"220000000002","display":"Invented name part"}]}
.... countryLanguage Σ0..*BackboneElementCountry where the name applies
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... country Σ1..1CodeableConceptCountry for where this name applies (code)
..... jurisdiction Σ0..1CodeableConceptJurisdiction code for where this name applies
..... language Σ1..1CodeableConceptLanguage for this name (code)
... crossReference Σ0..*BackboneElementReference to another product, e.g. for linking authorised to investigational product
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... product Σ1..1CodeableReference(MedicinalProductDefinition)Reference to another product, e.g. for linking authorised to investigational product
.... type Σ0..1CodeableConceptThe type of relationship, for instance branded to generic, product to development product (investigational), parallel import version
... operation Σ0..*BackboneElementA manufacturing or administrative process or step associated with (or performed on) the medicinal product
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ0..1CodeableReference(ActivityDefinition | PlanDefinition)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
.... effectiveDate Σ0..1PeriodDate range of applicability
.... organization Σ0..*Reference(Organization)The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent
.... confidentialityIndicator Σ0..1CodeableConceptSpecifies whether this particular business or manufacturing process is considered proprietary or confidential
... characteristic Σ0..*BackboneElementAllows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ1..1CodeableConceptA code expressing the type of characteristic
.... value[x] Σ0..1A value for the characteristic
..... valueCodeableConceptCodeableConcept
..... valueQuantityQuantity
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..*MedicinalProductDefinitionDetailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use, drug catalogs)

doco Documentation for this format

This structure is derived from MedicinalProductDefinition

Summary

Mandatory: 3 elements (2 nested mandatory elements)

Differential View

This structure is derived from MedicinalProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..*MedicinalProductDefinitionDetailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use, drug catalogs)
... identifier 1..*IdentifierBusiness identifier for this product. Could be an MPID
.... system 1..1uriThe namespace for the identifier value
Binding: MedicinalProductDefinition identifier systems (extensible)
.... value 1..1stringThe value that is unique
... type 0..1CodeableConceptRegulatory type, e.g. Investigational or Authorized
Binding: MedicinalProductType (extensible)
... domain 0..1CodeableConceptIf this medicine applies to human or veterinary uses
Binding: MedicinalProductDomain (extensible)
.... coding 1..*CodingCode defined by a terminology system
... status 0..1CodeableConceptThe 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
Binding: PublicationStatus (extensible)
... statusDate 0..1dateTimeThe date at which this status became applicable.
... description 0..1markdownGeneral description of the product referred by the ePI
... combinedPharmaceuticalDoseForm 0..1CodeableConceptThe dose form for a single part product or combined form of a multiple part product
... route 0..*CodeableConceptRoute of administration
... indication 0..1markdownDescription of indication(s) for this product, used when structured indications are not required.
... legalStatusOfSupply 0..1CodeableConceptThe legal status of supply of the medicinal product as classified by the regulator
Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"100000072084","display":"Medicinal product subject to medical prescription"}]}
.... coding 1..*CodingCode defined by a terminology system
... additionalMonitoringIndicator 0..1CodeableConceptAdditional monitoring this Medicinal Product is subject to (for regulatory reasons)
... pediatricUseIndicator 0..1CodeableConceptAuthorised pediatric use
... classification 0..*CodeableConceptClassifications used for this product
... marketingStatus 0..*MarketingStatusMarketing status of the medicinal product in contrast to marketing authorization
... packagedMedicinalProduct 0..*CodeableConceptPackage type for this product
... name
.... productName 1..1stringThe full name of this product
Example general: Humalog Mix50 Insulin KwikPen, 3ml pre-fill
.... type 0..1CodeableConceptType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"220000000001","display":"Full name"}]}
.... namePart
..... part 1..1stringA fragment of a product name
Example general: Humalog
..... type 1..1CodeableConceptIdentifying type for this part of the name (e.g. strength part)
Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"220000000002","display":"Invented name part"}]}
.... countryLanguage
..... country 1..1CodeableConceptCountry for where this name applies (code)
..... language 1..1CodeableConceptLanguage for this name (code)

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..*MedicinalProductDefinitionDetailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use, drug catalogs)
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): IETF language tag

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ1..*IdentifierBusiness identifier for this product. Could be an MPID
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required)
.... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible)
.... system Σ1..1uriThe namespace for the identifier value
Binding: MedicinalProductDefinition identifier systems (extensible)
Example General: http://www.acme.com/identifiers/patient
.... value Σ1..1stringThe value that is unique
Example General: 123456
.... period Σ0..1PeriodTime period when id is/was valid for use
.... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
... type Σ0..1CodeableConceptRegulatory type, e.g. Investigational or Authorized
Binding: MedicinalProductType (extensible)
... domain Σ0..1CodeableConceptIf this medicine applies to human or veterinary uses
Binding: MedicinalProductDomain (extensible)
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ1..*CodingCode defined by a terminology system
.... text Σ0..1stringPlain text representation of the concept
... version Σ0..1stringBusiness version of this product
... status ?!Σ0..1CodeableConceptThe 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
Binding: PublicationStatus (extensible)
... statusDate Σ0..1dateTimeThe date at which this status became applicable.
... description Σ0..1markdownGeneral description of the product referred by the ePI
... combinedPharmaceuticalDoseForm Σ0..1CodeableConceptThe dose form for a single part product or combined form of a multiple part product
Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing

... route Σ0..*CodeableConceptRoute of administration
Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.


... indication Σ0..1markdownDescription of indication(s) for this product, used when structured indications are not required.
... legalStatusOfSupply Σ0..1CodeableConceptThe legal status of supply of the medicinal product as classified by the regulator
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product


Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"100000072084","display":"Medicinal product subject to medical prescription"}]}
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ1..*CodingCode defined by a terminology system
.... text Σ0..1stringPlain text representation of the concept
... additionalMonitoringIndicator Σ0..1CodeableConceptAdditional monitoring this Medicinal Product is subject to (for regulatory reasons)
... specialMeasures Σ0..*CodeableConceptWhether the Medicinal Product is subject to special measures for regulatory reasons
... pediatricUseIndicator Σ0..1CodeableConceptAuthorised pediatric use
... classification Σ0..*CodeableConceptClassifications used for this product
... marketingStatus Σ0..*MarketingStatusMarketing status of the medicinal product in contrast to marketing authorization
... packagedMedicinalProduct Σ0..*CodeableConceptPackage type for this product
Binding: MedicinalProductPackageType (example): Types of medicinal product packs


... ingredient Σ0..*CodeableConceptThe 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
... impurity Σ0..*CodeableReference(SubstanceDefinition)Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products
... attachedDocument Σ0..*Reference(DocumentReference)Additional information or supporting documentation about the medicinal product
... masterFile Σ0..*Reference(DocumentReference)A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
... contact Σ0..*BackboneElementA product specific contact, person (in a role), or an organization
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ0..1CodeableConceptAllows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
.... contact Σ1..1Reference(Organization | PractitionerRole)A product specific contact, person (in a role), or an organization
... clinicalTrial Σ0..*Reference(ResearchStudy)Clinical trials or studies that this product is involved in
... code Σ0..*CodingA code that this product is known by, within some formal terminology
Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.


... name Σ1..*BackboneElementThe product's name, including full name and possibly coded parts
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... productName Σ1..1stringThe full name of this product
Example general: Humalog Mix50 Insulin KwikPen, 3ml pre-fill
.... type Σ0..1CodeableConceptType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"220000000001","display":"Full name"}]}
.... namePart Σ0..*BackboneElementCoding words or phrases of the name
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... part Σ1..1stringA fragment of a product name
Example general: Humalog
..... type Σ1..1CodeableConceptIdentifying type for this part of the name (e.g. strength part)
Example SPOR example: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"220000000002","display":"Invented name part"}]}
.... countryLanguage Σ0..*BackboneElementCountry where the name applies
..... id 0..1idUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... country Σ1..1CodeableConceptCountry for where this name applies (code)
..... jurisdiction Σ0..1CodeableConceptJurisdiction code for where this name applies
..... language Σ1..1CodeableConceptLanguage for this name (code)
... crossReference Σ0..*BackboneElementReference to another product, e.g. for linking authorised to investigational product
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... product Σ1..1CodeableReference(MedicinalProductDefinition)Reference to another product, e.g. for linking authorised to investigational product
.... type Σ0..1CodeableConceptThe type of relationship, for instance branded to generic, product to development product (investigational), parallel import version
... operation Σ0..*BackboneElementA manufacturing or administrative process or step associated with (or performed on) the medicinal product
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ0..1CodeableReference(ActivityDefinition | PlanDefinition)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
.... effectiveDate Σ0..1PeriodDate range of applicability
.... organization Σ0..*Reference(Organization)The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent
.... confidentialityIndicator Σ0..1CodeableConceptSpecifies whether this particular business or manufacturing process is considered proprietary or confidential
... characteristic Σ0..*BackboneElementAllows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ1..1CodeableConceptA code expressing the type of characteristic
.... value[x] Σ0..1A value for the characteristic
..... valueCodeableConceptCodeableConcept
..... valueQuantityQuantity
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSet
MedicinalProductDefinition.languagepreferredCommonLanguages
Max Binding: AllLanguages
MedicinalProductDefinition.identifier.userequiredIdentifierUse
MedicinalProductDefinition.identifier.typeextensibleIdentifier Type Codes
MedicinalProductDefinition.identifier.systemextensibleVsMedProductIdSystems
MedicinalProductDefinition.typeextensibleMedicinalProductType
MedicinalProductDefinition.domainextensibleMedicinalProductDomain
MedicinalProductDefinition.statusextensiblePublicationStatus
MedicinalProductDefinition.combinedPharmaceuticalDoseFormexampleCombinedDoseForm
MedicinalProductDefinition.routeexampleSNOMEDCTRouteCodes
MedicinalProductDefinition.legalStatusOfSupplyexampleLegalStatusOfSupply
MedicinalProductDefinition.packagedMedicinalProductexampleMedicinalProductPackageType
MedicinalProductDefinition.codeexampleSNOMEDCTMedicationCodes