Intersection of http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi and http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi

This is the set of resources that conform to both MedicinalProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi) and MedicinalProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi).

Structure

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition 0..*Detailed definition of a medicinal product
... 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: ?? (required): IETF language tag for a human language
... text 0..1NarrativeText summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... identifier Σ1..*IdentifierBusiness identifier for this product. Could be an MPID
.... extension 0..*ExtensionAdditional content defined by implementations
.... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: ?? (required): Identifies the purpose for this identifier, if known .
.... type Σ0..1CodeableConceptDescription of identifier
Binding: ?? (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
.... system Σ1..1uriThe namespace for the identifier value
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: ?? (example): Overall defining type of this medicinal product.
... domain Σ0..1CodeableConceptIf this medicine applies to human or veterinary uses.
Binding: ?? (example)
... version Σ0..1stringA business identifier relating to a specific version of the product.
... status ?!Σ0..1CodeableConceptThe status within the lifecycle of this product record.
Binding: ?? (preferred): The lifecycle status of an artifact.
... statusDate Σ0..1dateTimeThe date at which this status became applicable.
... description Σ0..1markdownGeneral description of the medicinal product referred by the ePI
... combinedPharmaceuticalDoseForm Σ0..1CodeableConceptThe dose form for a single part product, or combined form of a multiple part product
Binding: ?? (example)
... route Σ0..*CodeableConceptThe path by which the product is taken into or makes contact with the body
Binding: ?? (example)
... indication Σ0..1markdownNarrative text of the authorized indication(s) for this product.
... legalStatusOfSupply Σ0..1CodeableConceptThe legal status of supply of the medicinal product as classified by the regulator.
Binding: ?? (example): The prescription supply types appropriate to a medicinal product
... additionalMonitoringIndicator Σ0..1CodeableConceptWhether the Medicinal Product is subject to additional monitoring for regulatory reasons.
Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).
... specialMeasures Σ0..*CodeableConceptWhether the Medicinal Product is subject to special measures for regulatory reasons.
Binding: ?? (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.
... pediatricUseIndicator Σ0..1CodeableConceptIf authorised for pediatric use
Binding: ?? (example): Suitability for age groups, in particular children.
... classification Σ0..*CodeableConceptAllows the product to be classified by various systems (e.g. ATC)
Binding: ?? (example)
... marketingStatus Σ0..*MarketingStatusMarketing status of the medicinal product, in contrast to marketing authorization
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... country Σ0..1CodeableConceptThe country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
Binding: ?? (preferred)
.... jurisdiction Σ0..1CodeableConceptWhere a Medicines Regulatory Agency has granted a marketing authorization 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
.... status Σ1..1CodeableConceptStatus of the marketing of the medicinal product.
.... dateRange Σ0..1PeriodThe date when the Medicinal Product is placed on the market by the Marketing Authorization Holder
.... restoreDate Σ0..1dateTimeThe date when the Medicinal Product is placed on the market by the Marketing Authorization 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
... packagedMedicinalProduct Σ0..*CodeableConceptPackage type for the product.
Binding: ?? (example): Types of medicinal product packs
... comprisedOf Σ0..*Reference(ManufacturedItemDefinition | DeviceDefinition)Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
... ingredient Σ0..*CodeableConceptThe ingredients of this medicinal product - when not detailed in other resources
Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
... 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
Binding: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
... attachedDocument Σ0..*Reference(DocumentReference)Additional 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
.... 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.
Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
.... contact Σ1..1Reference(Organization | PractitionerRole)A specific contact, person (in a role), or an organization for this product
... 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: ?? (example): A coded concept that defines the type of a medication.
... name Σ1..*BackboneElementThe product's name, including full name and possibly coded parts
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... productName Σ1..1stringleft: The full product name.; right: The full product name expressed as Proprietary Name (Non-Proprietary Name) strength dose form
.... type Σ0..1CodeableConceptType of product name, such as rINN, Proprietary, Non-Proprietary
Binding: ?? (example): Type of a name for a Medicinal Product.
.... part Σ0..*BackboneElementCoding words or phrases of the name
..... 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.
..... type Σ1..1CodeableConceptType for this part of the name (e.g. strength part)
Binding: ?? (example): Type of part of a name for a Medicinal Product.
.... usage Σ0..*BackboneElementCountry and jurisdiction where the name applies
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... country Σ1..1CodeableConceptCountry where this name applies
Binding: ?? (example): Jurisdiction codes
..... jurisdiction Σ0..1CodeableConceptJurisdiction where this name applies
Binding: ?? (example): Jurisdiction codes
..... language Σ1..1CodeableConceptLanguage for this name
Binding: ?? (required): IETF language tag for a human language
... crossReference Σ0..*BackboneElementReference to another product, e.g. for linking authorised to investigational product
.... 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 or virtual to actual product
Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
... operation Σ0..*BackboneElementA manufacturing or administrative process for the medicinal product
.... 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
.... effectiveDate Σ0..1PeriodDate range of applicability
.... organization Σ0..*Reference(Organization)The organization responsible for the particular process, e.g. the manufacturer or importer
.... confidentialityIndicator Σ0..1CodeableConceptSpecifies whether this process is considered proprietary or confidential
Binding: ?? (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
... characteristic Σ0..*BackboneElementKey product features such as "sugar free", "modified release"
.... 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
Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
.... value[x] Σ0..1A value for the characteristic
..... valueCodeableConceptCodeableConcept
..... valueMarkdownmarkdown
..... valueQuantityQuantity
..... valueIntegerinteger
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment

doco Documentation for this format