Union 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 either of the profiles 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). E.g. what you have to deal with if you get resources conforming to one of them

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.
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ1..1CodingCode defined by a terminology system
.... text Σ0..1stringPlain text representation of the concept
... domain Σ0..1CodeableConceptIf this medicine applies to human or veterinary uses.
Binding: ?? (example): Applicable domain for this product (e.g. human, veterinary).
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ1..1CodingCode defined by a terminology system
.... text Σ0..1stringPlain text representation of the concept
... 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.
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ1..1CodingCode defined by a terminology system
.... text Σ0..1stringPlain text representation of the concept
... statusDate Σ0..1dateTimeleft: The date at which this status became applicable.; right: Date of status change
... description Σ0..1markdownGeneral description of the medicinal product referred by the ePI
... combinedPharmaceuticalDoseForm Σ0..1CodeableConceptleft: The dose form for a single part product, or combined form of a multiple part product; right: The dose form for a single part product, or combined form of a multiple part product.
Binding: ?? (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ1..1CodingCode defined by a terminology system
.... text Σ0..1stringPlain text representation of the concept
... route Σ0..*CodeableConceptleft: The path by which the product is taken into or makes contact with the body; right: The path by which the product is taken into or makes contact with the body.
Binding: ?? (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
... 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
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ1..1CodingCode defined by a terminology system
.... text Σ0..1stringPlain text representation of the concept
... additionalMonitoringIndicator Σ0..1CodeableConceptleft: Whether the Medicinal Product is subject to additional monitoring for regulatory reasons.; right: Whether 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).
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ1..1CodingCode defined by a terminology system
.... text Σ0..1stringPlain text representation of the concept
... specialMeasures Σ0..*CodeableConceptleft: Whether the Medicinal Product is subject to special measures for regulatory reasons.; right: Whether 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.
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ1..1CodingCode defined by a terminology system
.... text Σ0..1stringPlain text representation of the concept
... pediatricUseIndicator Σ0..1CodeableConceptleft: If authorised for pediatric use; right: If authorised for use in children
Binding: ?? (example): Suitability for age groups, in particular children.
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ1..1CodingCode defined by a terminology system
.... text Σ0..1stringPlain text representation of the concept
... classification Σ0..*CodeableConceptleft: Allows the product to be classified by various systems (e.g. ATC); right: Allows the product to be classified by various systems
Binding: ?? (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ1..1CodingCode defined by a terminology system
.... text Σ0..1stringPlain text representation of the concept
... marketingStatus Σ0..*MarketingStatusleft: Marketing status of the medicinal product, in contrast to marketing authorization; right: Marketing 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: ?? (example)
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ1..1CodingCode defined by a terminology system
..... text Σ0..1stringPlain text representation of the concept
.... 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..1CodeableConceptleft: Status of the marketing of the medicinal product.; right: This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ1..1CodingCode defined by a terminology system
..... text Σ0..1stringPlain text representation of the concept
.... dateRange Σ0..1Periodleft: The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder; right: The date when the status became effective.
.... 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..*CodeableConceptleft: Package type for the product.; right: Package representation for the product.
Binding: ?? (example): Types of medicinal product packs
... comprisedOf Σ0..*Reference(ManufacturedItemDefinition | DeviceDefinition)left: Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes; right: Types of manufactured items that are part of this product.
... ingredient Σ0..*CodeableConceptleft: The ingredients of this medicinal product - when not detailed in other resources; right: The 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..*BackboneElementleft: A product specific contact, person (in a role), or an organization; right: A 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..1CodeableConceptleft: Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.; right: Allows 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.
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ1..1CodingCode defined by a terminology system
..... text Σ0..1stringPlain text representation of the concept
.... contact Σ1..1Reference(Organization | PractitionerRole)left: A specific contact, person (in a role), or an organization for this product; right: 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: ?? (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..1CodeableConceptleft: Type of product name, such as rINN, Proprietary, Non-Proprietary; right: Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ?? (example): Type of a name for a Medicinal Product.
..... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ1..1CodingCode defined by a terminology system
..... text Σ0..1stringPlain text representation of the concept
.... 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..1stringleft: A fragment of a product name.; right: A fragment of a product name
..... type Σ1..1CodeableConceptleft: Type for this part of the name (e.g. strength part); right: Identifying type for this part of the name (e.g. strength part)
Binding: ?? (example): Type of part of a name for a Medicinal Product.
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ1..1CodingCode defined by a terminology system
...... text Σ0..1stringPlain text representation of the concept
.... usage Σ0..*BackboneElementleft: Country and jurisdiction where the name applies; right: Country 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..1CodeableConceptleft: Country where this name applies; right: Country code for where this name applies
Binding: ?? (example): Jurisdiction codes
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ1..1CodingCode defined by a terminology system
...... text Σ0..1stringPlain text representation of the concept
..... jurisdiction Σ0..1CodeableConceptleft: Jurisdiction where this name applies; right: Jurisdiction code for where this name applies
Binding: ?? (example): Jurisdiction codes
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ1..1CodingCode defined by a terminology system
...... text Σ0..1stringPlain text representation of the concept
..... language Σ1..1CodeableConceptleft: Language for this name; right: Language code for this name
Binding: ?? (required): IETF language tag for a human language
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ1..1CodingCode defined by a terminology system
...... text Σ0..1stringPlain text representation of the concept
... 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