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15.1 Resource MedicinalProductDefinition - Content

Biomedical Research and Regulation icon Work GroupMaturity Level: 3 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

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).

For an overview of this resource and others in the Medication Definition domain, also see the module page

The MedicinalProductDefinition resource covers the detailed defining data of medicinal products, to a level beyond what is typically needed for day to day prescribing, but that is commonly required by manufacturers and regulators, and also for use in drug catalogs and pharmacopoeias. (For direct patient care when prescribing the correct resource is Medication).

This product resource is associated with others that describe the packaging, the actual medication in its manufactured form (e.g. the tablet itself), its ingredients, and the substances within. These products are generally regulated by national or regional bodies or agencies. See note below about the RegulatedAuthorization resource.

The administrable (or "pharmaceutical") product - which differs in that it is now "mixed" from its components (if necessary) and is ready for use - is covered by the AdministrableProductDefinition resource.

This MedicinalProductDefinition resource is the one that represents the product as a whole, even though some parts of the full data model are in the other resources of this module. The full product is actually represented by several resources working together - it can be thought of as one large model.

Each part can be used individually to represent some aspects of the full product. But the product as a whole, should be a MedicinalProductDefinition. (As an example, if just a representation of the individual tablet of a product is needed, just the ManufacturedItemDefinition resource can be used. But that doesn't make the tablet into a "product" - it is still just the physical manifestation of an overall drug product. There is logically a MedicinalProductDefinition there too, even if it is not being used or transmitted at this time.)

The MedicinalProductDefinition resource acts as a "header", representing the product itself, and is the unit that is generally submitted for regulation (and is approved for sale), or that appears in a drug catalog or pharmacopoeia.

A list of drug definitions would be list of MedicinalProductDefinitions, but each would have a series of associated packs and manufactured items (and ingredients etc.), with references to the appropriate resources.

The "product level" at the top has features such as names and identifiers, classifications, legal status, and usage characteristics (indications, contra-indications) since they are common to all package types available for this product, the tablets (or powders etc.) that physically are the medication, as well as the form of the drug that is eventually given to the patient.

A product can have multiple pack types - which may come and go over time - and the existence of differing package options (different amounts of the drug, or bottle vs. packet) is one of the reasons to have an overarching product record that collates them all.

A product is normally limited to a single formulation (set of ingredients) and physical form and strength. These defining characteristics are some of the key features that marketing approvals and approved usage indications are based on. A change of any of these would usually mean a different product - a different MedicinalProductDefinition instance - and a different approval being needed.

A key aspect of a regulated medicinal product is the authorisation (marketing authorisation). This is not directly carried on the product resource, but instead a RegulatedAuthorization resource is created which points back to this resource.

Due to the amount of information, cardinalities, and update granularity necessary for some applications, the full product model is split over several resources.

If you need just a coded "package type" list for your product you can use MedicinalProductDefinition.packagedMedicinalProduct. But full package information goes in an instance of PackagedProductDefinition resource (linked back to the MedicinalProductDefinition using PackagedProductDefinition.productFor).

There are occasions where an identified package is not necessary, and yet one or more parts of the PackagedProductDefinition resource are needed. In this case it may be appropriate to use a contained PackagedProductDefinition resource. Similarly if the Ingredient resource is too much, but a link to a substance as component part of a product is needed, consider a contained Ingredient, that links straight to a SubstanceDefinition.

This example demonstrates both of these cases.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition TUDomainResourceDetailed definition of a medicinal product

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness identifier for this product. Could be an MPID

... type Σ0..1CodeableConceptRegulatory type, e.g. Investigational or Authorized
MedicinalProductType (Example)
... domain Σ0..1CodeableConceptIf this medicine applies to human or veterinary uses
MedicinalProductDomain (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
PublicationStatus (Preferred)
... statusDate Σ0..1dateTimeThe date at which the given status became applicable
... description Σ0..1markdownGeneral description of this product
... combinedPharmaceuticalDoseForm Σ0..1CodeableConceptThe dose form for a single part product, or combined form of a multiple part product
CombinedDoseForm (Example)
... route Σ0..*CodeableConceptThe path by which the product is taken into or makes contact with the body
SNOMED CT Route Codes (Example)

... 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
LegalStatusOfSupply (Example)
... additionalMonitoringIndicator Σ0..1CodeableConceptWhether the Medicinal Product is subject to additional monitoring for regulatory reasons
AdditionalMonitoring (Example)
... specialMeasures Σ0..*CodeableConceptWhether the Medicinal Product is subject to special measures for regulatory reasons
SpecialMeasures (Example)

... pediatricUseIndicator Σ0..1CodeableConceptIf authorised for use in children
PediatricUse (Example)
... classification Σ0..*CodeableConceptAllows the product to be classified by various systems
ProductClassification (Example)

... marketingStatus Σ0..*MarketingStatusMarketing status of the medicinal product, in contrast to marketing authorization

... packagedMedicinalProduct Σ0..*CodeableConceptPackage type for the product
MedicinalProductPackageType (Example)

... 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
SNOMED CT Substance Codes (Example)

... 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
SNOMED CT Substance Codes (Example)

... 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

.... type Σ0..1CodeableConceptAllows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
ProductContactType (Example)
.... 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
SNOMED CT Medication Codes (Example)

... name Σ1..*BackboneElementThe product's name, including full name and possibly coded parts

.... productName Σ1..1stringThe full product name
.... type Σ0..1CodeableConceptType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
ProductNameType (Example)
.... part Σ0..*BackboneElementCoding words or phrases of the name

..... part Σ1..1stringA fragment of a product name
..... type Σ1..1CodeableConceptIdentifying type for this part of the name (e.g. strength part)
ProductNamePartType (Example)
.... usage Σ0..*BackboneElementCountry and jurisdiction where the name applies

..... country Σ1..1CodeableConceptCountry code for where this name applies
Country ValueSet (Example)
..... jurisdiction Σ0..1CodeableConceptJurisdiction code for where this name applies
Jurisdiction ValueSet (Example)
..... language Σ1..1CodeableConceptLanguage code for this name
Common Languages (Preferred but limited to AllLanguages)
... crossReference Σ0..*BackboneElementReference to another product, e.g. for linking authorised to investigational product

.... 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
ProductCrossReferenceType (Example)
... operation Σ0..*BackboneElementA manufacturing or administrative process for the medicinal product

.... 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
ProductConfidentiality (Example)
... characteristic Σ0..*BackboneElementKey product features such as "sugar free", "modified release"

.... type Σ1..1CodeableConceptA code expressing the type of characteristic
ProductCharacteristic (Example)
.... value[x] Σ0..1A value for the characteristic
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueQuantityQuantity
..... valueIntegerinteger
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment

doco Documentation for this format

See the Extensions for this resource

UML Diagram (Legend)

MedicinalProductDefinition (DomainResource)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.codeidentifier : Identifier [0..*]Regulatory type, e.g. Investigational or Authorizedtype : CodeableConcept [0..1] « null (Strength=Example)MedicinalProductType?? »If this medicine applies to human or veterinary usesdomain : CodeableConcept [0..1] « null (Strength=Example)MedicinalProductDomain?? »A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing productversion : string [0..1]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 (this element modifies the meaning of other elements)status : CodeableConcept [0..1] « null (Strength=Preferred)PublicationStatus? »The date at which the given status became applicablestatusDate : dateTime [0..1]General description of this productdescription : markdown [0..1]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)combinedPharmaceuticalDoseForm : CodeableConcept [0..1] « null (Strength=Example) CombinedDoseForm?? »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 togetherroute : CodeableConcept [0..*] « null (Strength=Example)SNOMEDCTRouteCodes?? »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 appropriateindication : markdown [0..1]The legal status of supply of the medicinal product as classified by the regulatorlegalStatusOfSupply : CodeableConcept [0..1] « null (Strength=Example)LegalStatusOfSupply?? »Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirementsadditionalMonitoringIndicator : CodeableConcept [0..1] « null (Strength=Example) AdditionalMonitoring?? »Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorisation studiesspecialMeasures : CodeableConcept [0..*] « null (Strength=Example)SpecialMeasures?? »If authorised for use in children, or infants, neonates etcpediatricUseIndicator : CodeableConcept [0..1] « null (Strength=Example)PediatricUse?? »Allows the product to be classified by various systems, commonly WHO ATCclassification : CodeableConcept [0..*] « null (Strength=Example)ProductClassification?? »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)marketingStatus : MarketingStatus [0..*]Package type for the product. See also the PackagedProductDefinition resourcepackagedMedicinalProduct : CodeableConcept [0..*] « null (Strength=Example) MedicinalProductPackageType?? »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)comprisedOf : Reference [0..*] « ManufacturedItemDefinition| DeviceDefinition »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 codesingredient : CodeableConcept [0..*] « null (Strength=Example)SNOMEDCTSubstanceCodes?? »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 productsimpurity : CodeableReference [0..*] « SubstanceDefinition; null (Strength=Example) SNOMEDCTSubstanceCodes?? »Additional information or supporting documentation about the medicinal productattachedDocument : Reference [0..*] « DocumentReference »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 productsmasterFile : Reference [0..*] « DocumentReference »Clinical trials or studies that this product is involved inclinicalTrial : Reference [0..*] « ResearchStudy »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 organizationscode : Coding [0..*] « null (Strength=Example)SNOMEDCTMedicationCodes?? »ContactAllows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Informationtype : CodeableConcept [0..1] « null (Strength=Example)ProductContactType?? »A product specific contact, person (in a role), or an organizationcontact : Reference [1..1] « Organization|PractitionerRole »NameThe full product nameproductName : string [1..1]Type of product name, such as rINN, BAN, Proprietary, Non-Proprietarytype : CodeableConcept [0..1] « null (Strength=Example)ProductNameType?? »PartA fragment of a product namepart : string [1..1]Identifying type for this part of the name (e.g. strength part)type : CodeableConcept [1..1] « null (Strength=Example)ProductNamePartType?? »UsageCountry code for where this name appliescountry : CodeableConcept [1..1] « null (Strength=Example)CountryValueSet?? »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)jurisdiction : CodeableConcept [0..1] « null (Strength=Example)JurisdictionValueSet?? »Language code for this namelanguage : CodeableConcept [1..1] « null (Strength=Preferred)CommonLanguages? »CrossReferenceReference to another product, e.g. for linking authorised to investigational productproduct : CodeableReference [1..1] « MedicinalProductDefinition »The type of relationship, for instance branded to generic, virtual to actual product, product to development product (investigational), parallel import versiontype : CodeableConcept [0..1] « null (Strength=Example)ProductCrossReferenceType?? »OperationThe 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 heretype : CodeableReference [0..1] « ActivityDefinition|PlanDefinition »Date range of applicabilityeffectiveDate : Period [0..1]The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agentorganization : Reference [0..*] « Organization »Specifies whether this particular business or manufacturing process is considered proprietary or confidentialconfidentialityIndicator : CodeableConcept [0..1] « null (Strength=Example) ProductConfidentiality?? »CharacteristicA code expressing the type of characteristictype : CodeableConcept [1..1] « null (Strength=Example)ProductCharacteristic?? »A value for the characteristic.textvalue[x] : DataType [0..1] « CodeableConcept|string|Quantity|integer| date|boolean|Attachment »A product specific contact, person (in a role), or an organizationcontact[0..*]Coding words or phrases of the namepart[0..*]Country and jurisdiction where the name applies, and associated languageusage[0..*]The product's name, including full name and possibly coded partsname[1..*]Reference to another product, e.g. for linking authorised to investigational product, or a virtual productcrossReference[0..*]A manufacturing or administrative process or step associated with (or performed on) the medicinal productoperation[0..*]Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"characteristic[0..*]

XML Template

<MedicinalProductDefinition xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Business identifier for this product. Could be an MPID --></identifier>
 <type><!-- 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized --></type>
 <domain><!-- 0..1 CodeableConcept If this medicine applies to human or veterinary uses --></domain>
 <version value="[string]"/><!-- 0..1 A business identifier relating to a specific version of the product -->
 <status><!-- 0..1 CodeableConcept The status within the lifecycle of this product record --></status>
 <statusDate value="[dateTime]"/><!-- 0..1 The date at which the given status became applicable -->
 <description value="[markdown]"/><!-- 0..1 General description of this product -->
 <combinedPharmaceuticalDoseForm><!-- 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product --></combinedPharmaceuticalDoseForm>
 <route><!-- 0..* CodeableConcept The path by which the product is taken into or makes contact with the body --></route>
 <indication value="[markdown]"/><!-- 0..1 Description of indication(s) for this product, used when structured indications are not required -->
 <legalStatusOfSupply><!-- 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator --></legalStatusOfSupply>
 <additionalMonitoringIndicator><!-- 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons --></additionalMonitoringIndicator>
 <specialMeasures><!-- 0..* CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons --></specialMeasures>
 <pediatricUseIndicator><!-- 0..1 CodeableConcept If authorised for use in children --></pediatricUseIndicator>
 <classification><!-- 0..* CodeableConcept Allows the product to be classified by various systems --></classification>
 <marketingStatus><!-- 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization --></marketingStatus>
 <packagedMedicinalProduct><!-- 0..* CodeableConcept Package type for the product --></packagedMedicinalProduct>
 <comprisedOf><!-- 0..* Reference(DeviceDefinition|ManufacturedItemDefinition) Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes --></comprisedOf>
 <ingredient><!-- 0..* CodeableConcept The ingredients of this medicinal product - when not detailed in other resources --></ingredient>
 <impurity><!-- 0..* 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 --></impurity>
 <attachedDocument><!-- 0..* Reference(DocumentReference) Additional documentation about the medicinal product --></attachedDocument>
 <masterFile><!-- 0..* Reference(DocumentReference) A master file for the medicinal product (e.g. Pharmacovigilance System Master File) --></masterFile>
 <contact>  <!-- 0..* A product specific contact, person (in a role), or an organization -->
  <type><!-- 0..1 CodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information --></type>
  <contact><!-- 1..1 Reference(Organization|PractitionerRole) A product specific contact, person (in a role), or an organization --></contact>
 </contact>
 <clinicalTrial><!-- 0..* Reference(ResearchStudy) Clinical trials or studies that this product is involved in --></clinicalTrial>
 <code><!-- 0..* Coding A code that this product is known by, within some formal terminology --></code>
 <name>  <!-- 1..* The product's name, including full name and possibly coded parts -->
  <productName value="[string]"/><!-- 1..1 The full product name -->
  <type><!-- 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary --></type>
  <part>  <!-- 0..* Coding words or phrases of the name -->
   <part value="[string]"/><!-- 1..1 A fragment of a product name -->
   <type><!-- 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part) --></type>
  </part>
  <usage>  <!-- 0..* Country and jurisdiction where the name applies -->
   <country><!-- 1..1 CodeableConcept Country code for where this name applies --></country>
   <jurisdiction><!-- 0..1 CodeableConcept Jurisdiction code for where this name applies --></jurisdiction>
   <language><!-- 1..1 CodeableConcept Language code for this name --></language>
  </usage>
 </name>
 <crossReference>  <!-- 0..* Reference to another product, e.g. for linking authorised to investigational product -->
  <product><!-- 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product --></product>
  <type><!-- 0..1 CodeableConcept The type of relationship, for instance branded to generic or virtual to actual product --></type>
 </crossReference>
 <operation>  <!-- 0..* A manufacturing or administrative process for the medicinal product -->
  <type><!-- 0..1 CodeableReference(ActivityDefinition|PlanDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging --></type>
  <effectiveDate><!-- 0..1 Period Date range of applicability --></effectiveDate>
  <organization><!-- 0..* Reference(Organization) The organization responsible for the particular process, e.g. the manufacturer or importer --></organization>
  <confidentialityIndicator><!-- 0..1 CodeableConcept Specifies whether this process is considered proprietary or confidential --></confidentialityIndicator>
 </operation>
 <characteristic>  <!-- 0..* Key product features such as "sugar free", "modified release" -->
  <type><!-- 1..1 CodeableConcept A code expressing the type of characteristic --></type>
  <value[x]><!-- 0..1 CodeableConcept|string|Quantity|integer|date|boolean|
    Attachment A value for the characteristic --></value[x]>
 </characteristic>
</MedicinalProductDefinition>

JSON Template

{doco
  "resourceType" : "MedicinalProductDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business identifier for this product. Could be an MPID
  "type" : { CodeableConcept }, // Regulatory type, e.g. Investigational or Authorized
  "domain" : { CodeableConcept }, // If this medicine applies to human or veterinary uses
  "version" : "<string>", // A business identifier relating to a specific version of the product
  "status" : { CodeableConcept }, // The status within the lifecycle of this product record
  "statusDate" : "<dateTime>", // The date at which the given status became applicable
  "description" : "<markdown>", // General description of this product
  "combinedPharmaceuticalDoseForm" : { CodeableConcept }, // The dose form for a single part product, or combined form of a multiple part product
  "route" : [{ CodeableConcept }], // The path by which the product is taken into or makes contact with the body
  "indication" : "<markdown>", // Description of indication(s) for this product, used when structured indications are not required
  "legalStatusOfSupply" : { CodeableConcept }, // The legal status of supply of the medicinal product as classified by the regulator
  "additionalMonitoringIndicator" : { CodeableConcept }, // Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
  "specialMeasures" : [{ CodeableConcept }], // Whether the Medicinal Product is subject to special measures for regulatory reasons
  "pediatricUseIndicator" : { CodeableConcept }, // If authorised for use in children
  "classification" : [{ CodeableConcept }], // Allows the product to be classified by various systems
  "marketingStatus" : [{ MarketingStatus }], // Marketing status of the medicinal product, in contrast to marketing authorization
  "packagedMedicinalProduct" : [{ CodeableConcept }], // Package type for the product
  "comprisedOf" : [{ Reference(DeviceDefinition|ManufacturedItemDefinition) }], // Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
  "ingredient" : [{ CodeableConcept }], // The ingredients of this medicinal product - when not detailed in other resources
  "impurity" : [{ 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
  "attachedDocument" : [{ Reference(DocumentReference) }], // Additional documentation about the medicinal product
  "masterFile" : [{ Reference(DocumentReference) }], // A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
  "contact" : [{ // A product specific contact, person (in a role), or an organization
    "type" : { CodeableConcept }, // Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
    "contact" : { Reference(Organization|PractitionerRole) } // R!  A product specific contact, person (in a role), or an organization
  }],
  "clinicalTrial" : [{ Reference(ResearchStudy) }], // Clinical trials or studies that this product is involved in
  "code" : [{ Coding }], // A code that this product is known by, within some formal terminology
  "name" : [{ // R!  The product's name, including full name and possibly coded parts
    "productName" : "<string>", // R!  The full product name
    "type" : { CodeableConcept }, // Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
    "part" : [{ // Coding words or phrases of the name
      "part" : "<string>", // R!  A fragment of a product name
      "type" : { CodeableConcept } // R!  Identifying type for this part of the name (e.g. strength part)
    }],
    "usage" : [{ // Country and jurisdiction where the name applies
      "country" : { CodeableConcept }, // R!  Country code for where this name applies
      "jurisdiction" : { CodeableConcept }, // Jurisdiction code for where this name applies
      "language" : { CodeableConcept } // R!  Language code for this name
    }]
  }],
  "crossReference" : [{ // Reference to another product, e.g. for linking authorised to investigational product
    "product" : { CodeableReference(MedicinalProductDefinition) }, // R!  Reference to another product, e.g. for linking authorised to investigational product
    "type" : { CodeableConcept } // The type of relationship, for instance branded to generic or virtual to actual product
  }],
  "operation" : [{ // A manufacturing or administrative process for the medicinal product
    "type" : { CodeableReference(ActivityDefinition|PlanDefinition) }, // The type of manufacturing operation e.g. manufacturing itself, re-packaging
    "effectiveDate" : { Period }, // Date range of applicability
    "organization" : [{ Reference(Organization) }], // The organization responsible for the particular process, e.g. the manufacturer or importer
    "confidentialityIndicator" : { CodeableConcept } // Specifies whether this process is considered proprietary or confidential
  }],
  "characteristic" : [{ // Key product features such as "sugar free", "modified release"
    "type" : { CodeableConcept }, // R!  A code expressing the type of characteristic
    // value[x]: A value for the characteristic. One of these 7:
    "valueCodeableConcept" : { CodeableConcept },
    "valueString" : "<string>",
    "valueQuantity" : { Quantity },
    "valueInteger" : <integer>,
    "valueDate" : "<date>",
    "valueBoolean" : <boolean>,
    "valueAttachment" : { Attachment }
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:MedicinalProductDefinition;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:MedicinalProductDefinition.identifier [ Identifier ], ... ; # 0..* Business identifier for this product. Could be an MPID
  fhir:MedicinalProductDefinition.type [ CodeableConcept ]; # 0..1 Regulatory type, e.g. Investigational or Authorized
  fhir:MedicinalProductDefinition.domain [ CodeableConcept ]; # 0..1 If this medicine applies to human or veterinary uses
  fhir:MedicinalProductDefinition.version [ string ]; # 0..1 A business identifier relating to a specific version of the product
  fhir:MedicinalProductDefinition.status [ CodeableConcept ]; # 0..1 The status within the lifecycle of this product record
  fhir:MedicinalProductDefinition.statusDate [ dateTime ]; # 0..1 The date at which the given status became applicable
  fhir:MedicinalProductDefinition.description [ markdown ]; # 0..1 General description of this product
  fhir:MedicinalProductDefinition.combinedPharmaceuticalDoseForm [ CodeableConcept ]; # 0..1 The dose form for a single part product, or combined form of a multiple part product
  fhir:MedicinalProductDefinition.route [ CodeableConcept ], ... ; # 0..* The path by which the product is taken into or makes contact with the body
  fhir:MedicinalProductDefinition.indication [ markdown ]; # 0..1 Description of indication(s) for this product, used when structured indications are not required
  fhir:MedicinalProductDefinition.legalStatusOfSupply [ CodeableConcept ]; # 0..1 The legal status of supply of the medicinal product as classified by the regulator
  fhir:MedicinalProductDefinition.additionalMonitoringIndicator [ CodeableConcept ]; # 0..1 Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
  fhir:MedicinalProductDefinition.specialMeasures [ CodeableConcept ], ... ; # 0..* Whether the Medicinal Product is subject to special measures for regulatory reasons
  fhir:MedicinalProductDefinition.pediatricUseIndicator [ CodeableConcept ]; # 0..1 If authorised for use in children
  fhir:MedicinalProductDefinition.classification [ CodeableConcept ], ... ; # 0..* Allows the product to be classified by various systems
  fhir:MedicinalProductDefinition.marketingStatus [ MarketingStatus ], ... ; # 0..* Marketing status of the medicinal product, in contrast to marketing authorization
  fhir:MedicinalProductDefinition.packagedMedicinalProduct [ CodeableConcept ], ... ; # 0..* Package type for the product
  fhir:MedicinalProductDefinition.comprisedOf [ Reference(DeviceDefinition|ManufacturedItemDefinition) ], ... ; # 0..* Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
  fhir:MedicinalProductDefinition.ingredient [ CodeableConcept ], ... ; # 0..* The ingredients of this medicinal product - when not detailed in other resources
  fhir:MedicinalProductDefinition.impurity [ CodeableReference(SubstanceDefinition) ], ... ; # 0..* Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
  fhir:MedicinalProductDefinition.attachedDocument [ Reference(DocumentReference) ], ... ; # 0..* Additional documentation about the medicinal product
  fhir:MedicinalProductDefinition.masterFile [ Reference(DocumentReference) ], ... ; # 0..* A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
  fhir:MedicinalProductDefinition.contact [ # 0..* A product specific contact, person (in a role), or an organization
    fhir:MedicinalProductDefinition.contact.type [ CodeableConcept ]; # 0..1 Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
    fhir:MedicinalProductDefinition.contact.contact [ Reference(Organization|PractitionerRole) ]; # 1..1 A product specific contact, person (in a role), or an organization
  ], ...;
  fhir:MedicinalProductDefinition.clinicalTrial [ Reference(ResearchStudy) ], ... ; # 0..* Clinical trials or studies that this product is involved in
  fhir:MedicinalProductDefinition.code [ Coding ], ... ; # 0..* A code that this product is known by, within some formal terminology
  fhir:MedicinalProductDefinition.name [ # 1..* The product's name, including full name and possibly coded parts
    fhir:MedicinalProductDefinition.name.productName [ string ]; # 1..1 The full product name
    fhir:MedicinalProductDefinition.name.type [ CodeableConcept ]; # 0..1 Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
    fhir:MedicinalProductDefinition.name.part [ # 0..* Coding words or phrases of the name
      fhir:MedicinalProductDefinition.name.part.part [ string ]; # 1..1 A fragment of a product name
      fhir:MedicinalProductDefinition.name.part.type [ CodeableConcept ]; # 1..1 Identifying type for this part of the name (e.g. strength part)
    ], ...;
    fhir:MedicinalProductDefinition.name.usage [ # 0..* Country and jurisdiction where the name applies
      fhir:MedicinalProductDefinition.name.usage.country [ CodeableConcept ]; # 1..1 Country code for where this name applies
      fhir:MedicinalProductDefinition.name.usage.jurisdiction [ CodeableConcept ]; # 0..1 Jurisdiction code for where this name applies
      fhir:MedicinalProductDefinition.name.usage.language [ CodeableConcept ]; # 1..1 Language code for this name
    ], ...;
  ], ...;
  fhir:MedicinalProductDefinition.crossReference [ # 0..* Reference to another product, e.g. for linking authorised to investigational product
    fhir:MedicinalProductDefinition.crossReference.product [ CodeableReference(MedicinalProductDefinition) ]; # 1..1 Reference to another product, e.g. for linking authorised to investigational product
    fhir:MedicinalProductDefinition.crossReference.type [ CodeableConcept ]; # 0..1 The type of relationship, for instance branded to generic or virtual to actual product
  ], ...;
  fhir:MedicinalProductDefinition.operation [ # 0..* A manufacturing or administrative process for the medicinal product
    fhir:MedicinalProductDefinition.operation.type [ CodeableReference(ActivityDefinition|PlanDefinition) ]; # 0..1 The type of manufacturing operation e.g. manufacturing itself, re-packaging
    fhir:MedicinalProductDefinition.operation.effectiveDate [ Period ]; # 0..1 Date range of applicability
    fhir:MedicinalProductDefinition.operation.organization [ Reference(Organization) ], ... ; # 0..* The organization responsible for the particular process, e.g. the manufacturer or importer
    fhir:MedicinalProductDefinition.operation.confidentialityIndicator [ CodeableConcept ]; # 0..1 Specifies whether this process is considered proprietary or confidential
  ], ...;
  fhir:MedicinalProductDefinition.characteristic [ # 0..* Key product features such as "sugar free", "modified release"
    fhir:MedicinalProductDefinition.characteristic.type [ CodeableConcept ]; # 1..1 A code expressing the type of characteristic
    # MedicinalProductDefinition.characteristic.value[x] : 0..1 A value for the characteristic. One of these 7
      fhir:MedicinalProductDefinition.characteristic.valueCodeableConcept [ CodeableConcept ]
      fhir:MedicinalProductDefinition.characteristic.valueString [ string ]
      fhir:MedicinalProductDefinition.characteristic.valueQuantity [ Quantity ]
      fhir:MedicinalProductDefinition.characteristic.valueInteger [ integer ]
      fhir:MedicinalProductDefinition.characteristic.valueDate [ date ]
      fhir:MedicinalProductDefinition.characteristic.valueBoolean [ boolean ]
      fhir:MedicinalProductDefinition.characteristic.valueAttachment [ Attachment ]
  ], ...;
]

Changes since R4

This resource did not exist in Release 3

This analysis is available as XML or JSON.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition TUDomainResourceDetailed definition of a medicinal product

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness identifier for this product. Could be an MPID

... type Σ0..1CodeableConceptRegulatory type, e.g. Investigational or Authorized
MedicinalProductType (Example)
... domain Σ0..1CodeableConceptIf this medicine applies to human or veterinary uses
MedicinalProductDomain (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
PublicationStatus (Preferred)
... statusDate Σ0..1dateTimeThe date at which the given status became applicable
... description Σ0..1markdownGeneral description of this product
... combinedPharmaceuticalDoseForm Σ0..1CodeableConceptThe dose form for a single part product, or combined form of a multiple part product
CombinedDoseForm (Example)
... route Σ0..*CodeableConceptThe path by which the product is taken into or makes contact with the body
SNOMED CT Route Codes (Example)

... 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
LegalStatusOfSupply (Example)
... additionalMonitoringIndicator Σ0..1CodeableConceptWhether the Medicinal Product is subject to additional monitoring for regulatory reasons
AdditionalMonitoring (Example)
... specialMeasures Σ0..*CodeableConceptWhether the Medicinal Product is subject to special measures for regulatory reasons
SpecialMeasures (Example)

... pediatricUseIndicator Σ0..1CodeableConceptIf authorised for use in children
PediatricUse (Example)
... classification Σ0..*CodeableConceptAllows the product to be classified by various systems
ProductClassification (Example)

... marketingStatus Σ0..*MarketingStatusMarketing status of the medicinal product, in contrast to marketing authorization

... packagedMedicinalProduct Σ0..*CodeableConceptPackage type for the product
MedicinalProductPackageType (Example)

... 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
SNOMED CT Substance Codes (Example)

... 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
SNOMED CT Substance Codes (Example)

... 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

.... type Σ0..1CodeableConceptAllows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
ProductContactType (Example)
.... 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
SNOMED CT Medication Codes (Example)

... name Σ1..*BackboneElementThe product's name, including full name and possibly coded parts

.... productName Σ1..1stringThe full product name
.... type Σ0..1CodeableConceptType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
ProductNameType (Example)
.... part Σ0..*BackboneElementCoding words or phrases of the name

..... part Σ1..1stringA fragment of a product name
..... type Σ1..1CodeableConceptIdentifying type for this part of the name (e.g. strength part)
ProductNamePartType (Example)
.... usage Σ0..*BackboneElementCountry and jurisdiction where the name applies

..... country Σ1..1CodeableConceptCountry code for where this name applies
Country ValueSet (Example)
..... jurisdiction Σ0..1CodeableConceptJurisdiction code for where this name applies
Jurisdiction ValueSet (Example)
..... language Σ1..1CodeableConceptLanguage code for this name
Common Languages (Preferred but limited to AllLanguages)
... crossReference Σ0..*BackboneElementReference to another product, e.g. for linking authorised to investigational product

.... 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
ProductCrossReferenceType (Example)
... operation Σ0..*BackboneElementA manufacturing or administrative process for the medicinal product

.... 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
ProductConfidentiality (Example)
... characteristic Σ0..*BackboneElementKey product features such as "sugar free", "modified release"

.... type Σ1..1CodeableConceptA code expressing the type of characteristic
ProductCharacteristic (Example)
.... value[x] Σ0..1A value for the characteristic
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueQuantityQuantity
..... valueIntegerinteger
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment

doco Documentation for this format

See the Extensions for this resource

UML Diagram (Legend)

MedicinalProductDefinition (DomainResource)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.codeidentifier : Identifier [0..*]Regulatory type, e.g. Investigational or Authorizedtype : CodeableConcept [0..1] « null (Strength=Example)MedicinalProductType?? »If this medicine applies to human or veterinary usesdomain : CodeableConcept [0..1] « null (Strength=Example)MedicinalProductDomain?? »A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing productversion : string [0..1]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 (this element modifies the meaning of other elements)status : CodeableConcept [0..1] « null (Strength=Preferred)PublicationStatus? »The date at which the given status became applicablestatusDate : dateTime [0..1]General description of this productdescription : markdown [0..1]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)combinedPharmaceuticalDoseForm : CodeableConcept [0..1] « null (Strength=Example) CombinedDoseForm?? »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 togetherroute : CodeableConcept [0..*] « null (Strength=Example)SNOMEDCTRouteCodes?? »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 appropriateindication : markdown [0..1]The legal status of supply of the medicinal product as classified by the regulatorlegalStatusOfSupply : CodeableConcept [0..1] « null (Strength=Example)LegalStatusOfSupply?? »Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirementsadditionalMonitoringIndicator : CodeableConcept [0..1] « null (Strength=Example) AdditionalMonitoring?? »Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorisation studiesspecialMeasures : CodeableConcept [0..*] « null (Strength=Example)SpecialMeasures?? »If authorised for use in children, or infants, neonates etcpediatricUseIndicator : CodeableConcept [0..1] « null (Strength=Example)PediatricUse?? »Allows the product to be classified by various systems, commonly WHO ATCclassification : CodeableConcept [0..*] « null (Strength=Example)ProductClassification?? »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)marketingStatus : MarketingStatus [0..*]Package type for the product. See also the PackagedProductDefinition resourcepackagedMedicinalProduct : CodeableConcept [0..*] « null (Strength=Example) MedicinalProductPackageType?? »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)comprisedOf : Reference [0..*] « ManufacturedItemDefinition| DeviceDefinition »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 codesingredient : CodeableConcept [0..*] « null (Strength=Example)SNOMEDCTSubstanceCodes?? »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 productsimpurity : CodeableReference [0..*] « SubstanceDefinition; null (Strength=Example) SNOMEDCTSubstanceCodes?? »Additional information or supporting documentation about the medicinal productattachedDocument : Reference [0..*] « DocumentReference »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 productsmasterFile : Reference [0..*] « DocumentReference »Clinical trials or studies that this product is involved inclinicalTrial : Reference [0..*] « ResearchStudy »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 organizationscode : Coding [0..*] « null (Strength=Example)SNOMEDCTMedicationCodes?? »ContactAllows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Informationtype : CodeableConcept [0..1] « null (Strength=Example)ProductContactType?? »A product specific contact, person (in a role), or an organizationcontact : Reference [1..1] « Organization|PractitionerRole »NameThe full product nameproductName : string [1..1]Type of product name, such as rINN, BAN, Proprietary, Non-Proprietarytype : CodeableConcept [0..1] « null (Strength=Example)ProductNameType?? »PartA fragment of a product namepart : string [1..1]Identifying type for this part of the name (e.g. strength part)type : CodeableConcept [1..1] « null (Strength=Example)ProductNamePartType?? »UsageCountry code for where this name appliescountry : CodeableConcept [1..1] « null (Strength=Example)CountryValueSet?? »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)jurisdiction : CodeableConcept [0..1] « null (Strength=Example)JurisdictionValueSet?? »Language code for this namelanguage : CodeableConcept [1..1] « null (Strength=Preferred)CommonLanguages? »CrossReferenceReference to another product, e.g. for linking authorised to investigational productproduct : CodeableReference [1..1] « MedicinalProductDefinition »The type of relationship, for instance branded to generic, virtual to actual product, product to development product (investigational), parallel import versiontype : CodeableConcept [0..1] « null (Strength=Example)ProductCrossReferenceType?? »OperationThe 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 heretype : CodeableReference [0..1] « ActivityDefinition|PlanDefinition »Date range of applicabilityeffectiveDate : Period [0..1]The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agentorganization : Reference [0..*] « Organization »Specifies whether this particular business or manufacturing process is considered proprietary or confidentialconfidentialityIndicator : CodeableConcept [0..1] « null (Strength=Example) ProductConfidentiality?? »CharacteristicA code expressing the type of characteristictype : CodeableConcept [1..1] « null (Strength=Example)ProductCharacteristic?? »A value for the characteristic.textvalue[x] : DataType [0..1] « CodeableConcept|string|Quantity|integer| date|boolean|Attachment »A product specific contact, person (in a role), or an organizationcontact[0..*]Coding words or phrases of the namepart[0..*]Country and jurisdiction where the name applies, and associated languageusage[0..*]The product's name, including full name and possibly coded partsname[1..*]Reference to another product, e.g. for linking authorised to investigational product, or a virtual productcrossReference[0..*]A manufacturing or administrative process or step associated with (or performed on) the medicinal productoperation[0..*]Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"characteristic[0..*]

XML Template

<MedicinalProductDefinition xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Business identifier for this product. Could be an MPID --></identifier>
 <type><!-- 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized --></type>
 <domain><!-- 0..1 CodeableConcept If this medicine applies to human or veterinary uses --></domain>
 <version value="[string]"/><!-- 0..1 A business identifier relating to a specific version of the product -->
 <status><!-- 0..1 CodeableConcept The status within the lifecycle of this product record --></status>
 <statusDate value="[dateTime]"/><!-- 0..1 The date at which the given status became applicable -->
 <description value="[markdown]"/><!-- 0..1 General description of this product -->
 <combinedPharmaceuticalDoseForm><!-- 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product --></combinedPharmaceuticalDoseForm>
 <route><!-- 0..* CodeableConcept The path by which the product is taken into or makes contact with the body --></route>
 <indication value="[markdown]"/><!-- 0..1 Description of indication(s) for this product, used when structured indications are not required -->
 <legalStatusOfSupply><!-- 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator --></legalStatusOfSupply>
 <additionalMonitoringIndicator><!-- 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons --></additionalMonitoringIndicator>
 <specialMeasures><!-- 0..* CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons --></specialMeasures>
 <pediatricUseIndicator><!-- 0..1 CodeableConcept If authorised for use in children --></pediatricUseIndicator>
 <classification><!-- 0..* CodeableConcept Allows the product to be classified by various systems --></classification>
 <marketingStatus><!-- 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization --></marketingStatus>
 <packagedMedicinalProduct><!-- 0..* CodeableConcept Package type for the product --></packagedMedicinalProduct>
 <comprisedOf><!-- 0..* Reference(DeviceDefinition|ManufacturedItemDefinition) Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes --></comprisedOf>
 <ingredient><!-- 0..* CodeableConcept The ingredients of this medicinal product - when not detailed in other resources --></ingredient>
 <impurity><!-- 0..* 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 --></impurity>
 <attachedDocument><!-- 0..* Reference(DocumentReference) Additional documentation about the medicinal product --></attachedDocument>
 <masterFile><!-- 0..* Reference(DocumentReference) A master file for the medicinal product (e.g. Pharmacovigilance System Master File) --></masterFile>
 <contact>  <!-- 0..* A product specific contact, person (in a role), or an organization -->
  <type><!-- 0..1 CodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information --></type>
  <contact><!-- 1..1 Reference(Organization|PractitionerRole) A product specific contact, person (in a role), or an organization --></contact>
 </contact>
 <clinicalTrial><!-- 0..* Reference(ResearchStudy) Clinical trials or studies that this product is involved in --></clinicalTrial>
 <code><!-- 0..* Coding A code that this product is known by, within some formal terminology --></code>
 <name>  <!-- 1..* The product's name, including full name and possibly coded parts -->
  <productName value="[string]"/><!-- 1..1 The full product name -->
  <type><!-- 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary --></type>
  <part>  <!-- 0..* Coding words or phrases of the name -->
   <part value="[string]"/><!-- 1..1 A fragment of a product name -->
   <type><!-- 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part) --></type>
  </part>
  <usage>  <!-- 0..* Country and jurisdiction where the name applies -->
   <country><!-- 1..1 CodeableConcept Country code for where this name applies --></country>
   <jurisdiction><!-- 0..1 CodeableConcept Jurisdiction code for where this name applies --></jurisdiction>
   <language><!-- 1..1 CodeableConcept Language code for this name --></language>
  </usage>
 </name>
 <crossReference>  <!-- 0..* Reference to another product, e.g. for linking authorised to investigational product -->
  <product><!-- 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product --></product>
  <type><!-- 0..1 CodeableConcept The type of relationship, for instance branded to generic or virtual to actual product --></type>
 </crossReference>
 <operation>  <!-- 0..* A manufacturing or administrative process for the medicinal product -->
  <type><!-- 0..1 CodeableReference(ActivityDefinition|PlanDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging --></type>
  <effectiveDate><!-- 0..1 Period Date range of applicability --></effectiveDate>
  <organization><!-- 0..* Reference(Organization) The organization responsible for the particular process, e.g. the manufacturer or importer --></organization>
  <confidentialityIndicator><!-- 0..1 CodeableConcept Specifies whether this process is considered proprietary or confidential --></confidentialityIndicator>
 </operation>
 <characteristic>  <!-- 0..* Key product features such as "sugar free", "modified release" -->
  <type><!-- 1..1 CodeableConcept A code expressing the type of characteristic --></type>
  <value[x]><!-- 0..1 CodeableConcept|string|Quantity|integer|date|boolean|
    Attachment A value for the characteristic --></value[x]>
 </characteristic>
</MedicinalProductDefinition>

JSON Template

{doco
  "resourceType" : "MedicinalProductDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business identifier for this product. Could be an MPID
  "type" : { CodeableConcept }, // Regulatory type, e.g. Investigational or Authorized
  "domain" : { CodeableConcept }, // If this medicine applies to human or veterinary uses
  "version" : "<string>", // A business identifier relating to a specific version of the product
  "status" : { CodeableConcept }, // The status within the lifecycle of this product record
  "statusDate" : "<dateTime>", // The date at which the given status became applicable
  "description" : "<markdown>", // General description of this product
  "combinedPharmaceuticalDoseForm" : { CodeableConcept }, // The dose form for a single part product, or combined form of a multiple part product
  "route" : [{ CodeableConcept }], // The path by which the product is taken into or makes contact with the body
  "indication" : "<markdown>", // Description of indication(s) for this product, used when structured indications are not required
  "legalStatusOfSupply" : { CodeableConcept }, // The legal status of supply of the medicinal product as classified by the regulator
  "additionalMonitoringIndicator" : { CodeableConcept }, // Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
  "specialMeasures" : [{ CodeableConcept }], // Whether the Medicinal Product is subject to special measures for regulatory reasons
  "pediatricUseIndicator" : { CodeableConcept }, // If authorised for use in children
  "classification" : [{ CodeableConcept }], // Allows the product to be classified by various systems
  "marketingStatus" : [{ MarketingStatus }], // Marketing status of the medicinal product, in contrast to marketing authorization
  "packagedMedicinalProduct" : [{ CodeableConcept }], // Package type for the product
  "comprisedOf" : [{ Reference(DeviceDefinition|ManufacturedItemDefinition) }], // Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
  "ingredient" : [{ CodeableConcept }], // The ingredients of this medicinal product - when not detailed in other resources
  "impurity" : [{ 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
  "attachedDocument" : [{ Reference(DocumentReference) }], // Additional documentation about the medicinal product
  "masterFile" : [{ Reference(DocumentReference) }], // A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
  "contact" : [{ // A product specific contact, person (in a role), or an organization
    "type" : { CodeableConcept }, // Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
    "contact" : { Reference(Organization|PractitionerRole) } // R!  A product specific contact, person (in a role), or an organization
  }],
  "clinicalTrial" : [{ Reference(ResearchStudy) }], // Clinical trials or studies that this product is involved in
  "code" : [{ Coding }], // A code that this product is known by, within some formal terminology
  "name" : [{ // R!  The product's name, including full name and possibly coded parts
    "productName" : "<string>", // R!  The full product name
    "type" : { CodeableConcept }, // Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
    "part" : [{ // Coding words or phrases of the name
      "part" : "<string>", // R!  A fragment of a product name
      "type" : { CodeableConcept } // R!  Identifying type for this part of the name (e.g. strength part)
    }],
    "usage" : [{ // Country and jurisdiction where the name applies
      "country" : { CodeableConcept }, // R!  Country code for where this name applies
      "jurisdiction" : { CodeableConcept }, // Jurisdiction code for where this name applies
      "language" : { CodeableConcept } // R!  Language code for this name
    }]
  }],
  "crossReference" : [{ // Reference to another product, e.g. for linking authorised to investigational product
    "product" : { CodeableReference(MedicinalProductDefinition) }, // R!  Reference to another product, e.g. for linking authorised to investigational product
    "type" : { CodeableConcept } // The type of relationship, for instance branded to generic or virtual to actual product
  }],
  "operation" : [{ // A manufacturing or administrative process for the medicinal product
    "type" : { CodeableReference(ActivityDefinition|PlanDefinition) }, // The type of manufacturing operation e.g. manufacturing itself, re-packaging
    "effectiveDate" : { Period }, // Date range of applicability
    "organization" : [{ Reference(Organization) }], // The organization responsible for the particular process, e.g. the manufacturer or importer
    "confidentialityIndicator" : { CodeableConcept } // Specifies whether this process is considered proprietary or confidential
  }],
  "characteristic" : [{ // Key product features such as "sugar free", "modified release"
    "type" : { CodeableConcept }, // R!  A code expressing the type of characteristic
    // value[x]: A value for the characteristic. One of these 7:
    "valueCodeableConcept" : { CodeableConcept },
    "valueString" : "<string>",
    "valueQuantity" : { Quantity },
    "valueInteger" : <integer>,
    "valueDate" : "<date>",
    "valueBoolean" : <boolean>,
    "valueAttachment" : { Attachment }
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:MedicinalProductDefinition;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:MedicinalProductDefinition.identifier [ Identifier ], ... ; # 0..* Business identifier for this product. Could be an MPID
  fhir:MedicinalProductDefinition.type [ CodeableConcept ]; # 0..1 Regulatory type, e.g. Investigational or Authorized
  fhir:MedicinalProductDefinition.domain [ CodeableConcept ]; # 0..1 If this medicine applies to human or veterinary uses
  fhir:MedicinalProductDefinition.version [ string ]; # 0..1 A business identifier relating to a specific version of the product
  fhir:MedicinalProductDefinition.status [ CodeableConcept ]; # 0..1 The status within the lifecycle of this product record
  fhir:MedicinalProductDefinition.statusDate [ dateTime ]; # 0..1 The date at which the given status became applicable
  fhir:MedicinalProductDefinition.description [ markdown ]; # 0..1 General description of this product
  fhir:MedicinalProductDefinition.combinedPharmaceuticalDoseForm [ CodeableConcept ]; # 0..1 The dose form for a single part product, or combined form of a multiple part product
  fhir:MedicinalProductDefinition.route [ CodeableConcept ], ... ; # 0..* The path by which the product is taken into or makes contact with the body
  fhir:MedicinalProductDefinition.indication [ markdown ]; # 0..1 Description of indication(s) for this product, used when structured indications are not required
  fhir:MedicinalProductDefinition.legalStatusOfSupply [ CodeableConcept ]; # 0..1 The legal status of supply of the medicinal product as classified by the regulator
  fhir:MedicinalProductDefinition.additionalMonitoringIndicator [ CodeableConcept ]; # 0..1 Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
  fhir:MedicinalProductDefinition.specialMeasures [ CodeableConcept ], ... ; # 0..* Whether the Medicinal Product is subject to special measures for regulatory reasons
  fhir:MedicinalProductDefinition.pediatricUseIndicator [ CodeableConcept ]; # 0..1 If authorised for use in children
  fhir:MedicinalProductDefinition.classification [ CodeableConcept ], ... ; # 0..* Allows the product to be classified by various systems
  fhir:MedicinalProductDefinition.marketingStatus [ MarketingStatus ], ... ; # 0..* Marketing status of the medicinal product, in contrast to marketing authorization
  fhir:MedicinalProductDefinition.packagedMedicinalProduct [ CodeableConcept ], ... ; # 0..* Package type for the product
  fhir:MedicinalProductDefinition.comprisedOf [ Reference(DeviceDefinition|ManufacturedItemDefinition) ], ... ; # 0..* Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
  fhir:MedicinalProductDefinition.ingredient [ CodeableConcept ], ... ; # 0..* The ingredients of this medicinal product - when not detailed in other resources
  fhir:MedicinalProductDefinition.impurity [ CodeableReference(SubstanceDefinition) ], ... ; # 0..* Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
  fhir:MedicinalProductDefinition.attachedDocument [ Reference(DocumentReference) ], ... ; # 0..* Additional documentation about the medicinal product
  fhir:MedicinalProductDefinition.masterFile [ Reference(DocumentReference) ], ... ; # 0..* A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
  fhir:MedicinalProductDefinition.contact [ # 0..* A product specific contact, person (in a role), or an organization
    fhir:MedicinalProductDefinition.contact.type [ CodeableConcept ]; # 0..1 Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
    fhir:MedicinalProductDefinition.contact.contact [ Reference(Organization|PractitionerRole) ]; # 1..1 A product specific contact, person (in a role), or an organization
  ], ...;
  fhir:MedicinalProductDefinition.clinicalTrial [ Reference(ResearchStudy) ], ... ; # 0..* Clinical trials or studies that this product is involved in
  fhir:MedicinalProductDefinition.code [ Coding ], ... ; # 0..* A code that this product is known by, within some formal terminology
  fhir:MedicinalProductDefinition.name [ # 1..* The product's name, including full name and possibly coded parts
    fhir:MedicinalProductDefinition.name.productName [ string ]; # 1..1 The full product name
    fhir:MedicinalProductDefinition.name.type [ CodeableConcept ]; # 0..1 Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
    fhir:MedicinalProductDefinition.name.part [ # 0..* Coding words or phrases of the name
      fhir:MedicinalProductDefinition.name.part.part [ string ]; # 1..1 A fragment of a product name
      fhir:MedicinalProductDefinition.name.part.type [ CodeableConcept ]; # 1..1 Identifying type for this part of the name (e.g. strength part)
    ], ...;
    fhir:MedicinalProductDefinition.name.usage [ # 0..* Country and jurisdiction where the name applies
      fhir:MedicinalProductDefinition.name.usage.country [ CodeableConcept ]; # 1..1 Country code for where this name applies
      fhir:MedicinalProductDefinition.name.usage.jurisdiction [ CodeableConcept ]; # 0..1 Jurisdiction code for where this name applies
      fhir:MedicinalProductDefinition.name.usage.language [ CodeableConcept ]; # 1..1 Language code for this name
    ], ...;
  ], ...;
  fhir:MedicinalProductDefinition.crossReference [ # 0..* Reference to another product, e.g. for linking authorised to investigational product
    fhir:MedicinalProductDefinition.crossReference.product [ CodeableReference(MedicinalProductDefinition) ]; # 1..1 Reference to another product, e.g. for linking authorised to investigational product
    fhir:MedicinalProductDefinition.crossReference.type [ CodeableConcept ]; # 0..1 The type of relationship, for instance branded to generic or virtual to actual product
  ], ...;
  fhir:MedicinalProductDefinition.operation [ # 0..* A manufacturing or administrative process for the medicinal product
    fhir:MedicinalProductDefinition.operation.type [ CodeableReference(ActivityDefinition|PlanDefinition) ]; # 0..1 The type of manufacturing operation e.g. manufacturing itself, re-packaging
    fhir:MedicinalProductDefinition.operation.effectiveDate [ Period ]; # 0..1 Date range of applicability
    fhir:MedicinalProductDefinition.operation.organization [ Reference(Organization) ], ... ; # 0..* The organization responsible for the particular process, e.g. the manufacturer or importer
    fhir:MedicinalProductDefinition.operation.confidentialityIndicator [ CodeableConcept ]; # 0..1 Specifies whether this process is considered proprietary or confidential
  ], ...;
  fhir:MedicinalProductDefinition.characteristic [ # 0..* Key product features such as "sugar free", "modified release"
    fhir:MedicinalProductDefinition.characteristic.type [ CodeableConcept ]; # 1..1 A code expressing the type of characteristic
    # MedicinalProductDefinition.characteristic.value[x] : 0..1 A value for the characteristic. One of these 7
      fhir:MedicinalProductDefinition.characteristic.valueCodeableConcept [ CodeableConcept ]
      fhir:MedicinalProductDefinition.characteristic.valueString [ string ]
      fhir:MedicinalProductDefinition.characteristic.valueQuantity [ Quantity ]
      fhir:MedicinalProductDefinition.characteristic.valueInteger [ integer ]
      fhir:MedicinalProductDefinition.characteristic.valueDate [ date ]
      fhir:MedicinalProductDefinition.characteristic.valueBoolean [ boolean ]
      fhir:MedicinalProductDefinition.characteristic.valueAttachment [ Attachment ]
  ], ...;
]

Changes since Release 4

This resource did not exist in Release 3

This analysis is available as XML or JSON.

 

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

PathDefinitionTypeReference
MedicinalProductDefinition.type

Overall defining type of this Medicinal Product.

ExampleMedicinalProductType
MedicinalProductDefinition.domain

Applicable domain for this product (e.g. human, veterinary)

ExampleMedicinalProductDomain
MedicinalProductDefinition.status

The lifecycle status of an artifact.

PreferredPublicationStatus
MedicinalProductDefinition.combinedPharmaceuticalDoseForm

Dose forms for a product as a whole, considering all individual parts, but before any mixing

ExampleCombinedDoseForm
MedicinalProductDefinition.route

This value set includes all Route codes from SNOMED CT - provided as an exemplar.

ExampleSNOMEDCTRouteCodes
MedicinalProductDefinition.legalStatusOfSupply

The prescription supply types appropriate to a medicinal product

ExampleLegalStatusOfSupply
MedicinalProductDefinition.additionalMonitoringIndicator

Extra monitoring defined for a Medicinal Product.

ExampleAdditionalMonitoring
MedicinalProductDefinition.specialMeasures

Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorisation studies.

ExampleSpecialMeasures
MedicinalProductDefinition.pediatricUseIndicator

Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

ExamplePediatricUse
MedicinalProductDefinition.classification

This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.

ExampleProductClassification
MedicinalProductDefinition.packagedMedicinalProduct

Types of medicinal product packs

ExampleMedicinalProductPackageType
MedicinalProductDefinition.ingredient

This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

ExampleSNOMEDCTSubstanceCodes
MedicinalProductDefinition.impurity

This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

ExampleSNOMEDCTSubstanceCodes
MedicinalProductDefinition.contact.type

Contact type for a Medicinal Product.

ExampleProductContactType
MedicinalProductDefinition.code

This value set includes all drug or medicament substance codes and all pharmaceutical/biologic products from SNOMED CT - provided as an exemplar value set.

ExampleSNOMEDCTMedicationCodes
MedicinalProductDefinition.name.type

Type of a name for a Medicinal Product.

ExampleProductNameType
MedicinalProductDefinition.name.part.type

Type of part of a name for a Medicinal Product.

ExampleProductNamePartType
MedicinalProductDefinition.name.usage.country

This value set defines a base set of codes for countries.

Note: The codes for countries are taken from ISO 3166 icon.

ExampleCountryValueSet
MedicinalProductDefinition.name.usage.jurisdiction

This value set defines a base set of codes for country, country subdivision and region for indicating where a resource is intended to be used.

Note: The codes for countries and country subdivisions are taken from ISO 3166 icon while the codes for "supra-national" regions are from UN Standard country or area codes for statistical use (M49) icon.

ExampleJurisdictionValueSet
MedicinalProductDefinition.name.usage.language

This value set includes common codes from BCP-47 (http://tools.ietf.org/html/bcp47)

Preferred, but limited to AllLanguagesCommonLanguages
MedicinalProductDefinition.crossReference.type

Relationship to another Medicinal Product.

ExampleProductCrossReferenceType
MedicinalProductDefinition.operation.confidentialityIndicator

Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.

ExampleProductConfidentiality
MedicinalProductDefinition.characteristic.type

This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

ExampleProductCharacteristic

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

NameTypeDescriptionExpressionIn Common
characteristictokenAllows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"MedicinalProductDefinition.characteristic.value
characteristic-typetokenA category for the characteristicMedicinalProductDefinition.characteristic.type
contactreferenceA product specific contact, person (in a role), or an organizationMedicinalProductDefinition.contact.contact
(Organization, PractitionerRole)
domaintokenIf this medicine applies to human or veterinary usesMedicinalProductDefinition.domain
identifiertokenBusiness identifier for this product. Could be an MPIDMedicinalProductDefinition.identifier
ingredient DtokenAn ingredient of this productMedicinalProductDefinition.ingredient
master-filereferenceA master file for to the medicinal product (e.g. Pharmacovigilance System Master File)MedicinalProductDefinition.masterFile
(DocumentReference)
name NstringThe full product nameMedicinalProductDefinition.name.productName
name-languagetokenLanguage code for this nameMedicinalProductDefinition.name.usage.language
product-classificationtokenAllows the product to be classified by various systemsMedicinalProductDefinition.classification
statustokenThe 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 statusMedicinalProductDefinition.status
typetokenRegulatory type, e.g. Investigational or AuthorizedMedicinalProductDefinition.type