Release 5 Preview #3

15.1 Resource MedicinalProductDefinition - Content

Biomedical Research and Regulation Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use, 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 ManufacturedItemDefintion 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.

This resource is referenced by AdministrableProductDefinition, ClinicalUseIssue, MedicationKnowledge, PackagedProductDefinition, PlanDefinition and RegulatedAuthorization.

This resource does not implement any patterns.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition ΣTUDomainResourceDetailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use, drug catalogs)
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
... domain Σ0..1CodeableConceptIf this medicine applies to human or veterinary uses
... version Σ0..1stringA business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product
... status Σ0..1CodeableConceptThe status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status
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
... indication Σ0..1markdownDescription 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 ClinicalUseIssue resource. An indication is a medical situation for which using the product is appropriate
... legalStatusOfSupply Σ0..1CodeableConceptThe legal status of supply of the medicinal product as classified by the regulator
... additionalMonitoringIndicator Σ0..1CodeableConceptWhether the Medicinal Product is subject to additional monitoring for regulatory reasons
... specialMeasures Σ0..*CodeableConceptWhether the Medicinal Product is subject to special measures for regulatory reasons
... paediatricUseIndicator Σ0..1CodeableConceptIf authorised for use in children
... classification Σ0..*CodeableConceptAllows the product to be classified by various systems
... characteristic Σ0..*CodeableConceptAllows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"
... marketingStatus Σ0..*MarketingStatusMarketing status of the medicinal product, in contrast to marketing authorization
... packagedMedicinalProduct Σ0..*CodeableReference(PackagedProductDefinition)Package representation for the product
... ingredient Σ0..*CodeableReference(Ingredient)The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly here
... impurity Σ0..*Reference(SubstanceDefinition)Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products
... attachedDocument Σ0..*Reference(DocumentReference)Additional information or supporting documentation about the medicinal product
... masterFile Σ0..*Reference(DocumentReference)A master file for to 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
.... 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
... 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
.... namePart 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)
.... countryLanguage Σ0..*BackboneElementCountry where the name applies
..... country Σ1..1CodeableConceptCountry code for where this name applies
..... jurisdiction Σ0..1CodeableConceptJurisdiction code for where this name applies
..... language Σ1..1CodeableConceptLanguage code for this name
... 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, product to development product (investigational), parallel import version
... operation Σ0..*BackboneElementA manufacturing or administrative process or step associated with (or performed on) the medicinal product
.... type Σ0..1CodeableReference(ActivityDefinition)The type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute
.... effectiveDate Σ0..1PeriodDate range of applicability
.... organization Σ0..*Reference(Organization)The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent
.... authorization Σ0..1Reference(RegulatedAuthorization)An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a part
.... confidentialityIndicator Σ0..1CodeableConceptSpecifies whether this particular business or manufacturing process is considered proprietary or confidential
... administrableProduct Σ0..*BackboneElementThe product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable item
.... route Σ0..*CodeableConceptThe 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
.... product Σ0..1Reference(AdministrableProductDefinition)Full description of the administrable product

doco Documentation for this format

UML Diagram (Legend)

MedicinalProductDefinition (DomainResource)Business identifier for this product. Could be an MPIDidentifier : Identifier [0..*]Regulatory type, e.g. Investigational or Authorizedtype : CodeableConcept [0..1]If this medicine applies to human or veterinary usesdomain : CodeableConcept [0..1]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 statusstatus : CodeableConcept [0..1] « Identifies the level of importance to be assigned to actioning the request. (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 productcombinedPharmaceuticalDoseForm : CodeableConcept [0..1]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 ClinicalUseIssue 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]Whether the Medicinal Product is subject to additional monitoring for regulatory reasonsadditionalMonitoringIndicator : CodeableConcept [0..1]Whether the Medicinal Product is subject to special measures for regulatory reasonsspecialMeasures : CodeableConcept [0..*]If authorised for use in childrenpaediatricUseIndicator : CodeableConcept [0..1]Allows the product to be classified by various systemsclassification : CodeableConcept [0..*]Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"characteristic : CodeableConcept [0..*]Marketing status of the medicinal product, in contrast to marketing authorizationmarketingStatus : MarketingStatus [0..*]Package representation for the productpackagedMedicinalProduct : DataType [0..*] « PackagedProductDefinition »The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly hereingredient : DataType [0..*] « Ingredient »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 : Reference [0..*] « SubstanceDefinition »Additional information or supporting documentation about the medicinal productattachedDocument : Reference [0..*] « DocumentReference »A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)masterFile : Reference [0..*] « DocumentReference »Clinical trials or studies that this product is involved inclinicalTrial : Reference [0..*] « ResearchStudy »ContactAllows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Informationtype : CodeableConcept [0..1]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]NamePartA fragment of a product namepart : string [1..1]Identifying type for this part of the name (e.g. strength part)type : CodeableConcept [1..1]CountryLanguageCountry code for where this name appliescountry : CodeableConcept [1..1]Jurisdiction code for where this name appliesjurisdiction : CodeableConcept [0..1]Language code for this namelanguage : CodeableConcept [1..1]CrossReferenceReference to another product, e.g. for linking authorised to investigational productproduct : DataType [1..1] « MedicinalProductDefinition »The type of relationship, for instance branded to generic, product to development product (investigational), parallel import versiontype : CodeableConcept [0..1]OperationThe type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attributetype : DataType [0..1] « ActivityDefinition »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 »An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a partauthorization : Reference [0..1] « RegulatedAuthorization »Specifies whether this particular business or manufacturing process is considered proprietary or confidentialconfidentialityIndicator : CodeableConcept [0..1]AdministrableProductThe 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 routeroute : CodeableConcept [0..*]Full description of the administrable productproduct : Reference [0..1] « AdministrableProductDefinition »A product specific contact, person (in a role), or an organizationcontact[0..*]Coding words or phrases of the namenamePart[0..*]Country where the name appliescountryLanguage[0..*]The product's name, including full name and possibly coded partsname[1..*]Reference to another product, e.g. for linking authorised to investigational productcrossReference[0..*]A manufacturing or administrative process or step associated with (or performed on) the medicinal productoperation[0..*]The product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable itemadministrableProduct[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, this is commonly used to support revisions to an existing product -->
 <status><!-- 0..1 CodeableConcept 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 --></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>
 <indication value="[markdown]"/><!-- 0..1 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 ClinicalUseIssue resource. An indication is a medical situation for which using the product is appropriate -->
 <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>
 <paediatricUseIndicator><!-- 0..1 CodeableConcept If authorised for use in children --></paediatricUseIndicator>
 <classification><!-- 0..* CodeableConcept Allows the product to be classified by various systems --></classification>
 <characteristic><!-- 0..* CodeableConcept Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import" --></characteristic>
 <marketingStatus><!-- 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization --></marketingStatus>
 <packagedMedicinalProduct><!-- 0..* CodeableReference(PackagedProductDefinition) Package representation for the product --></packagedMedicinalProduct>
 <ingredient><!-- 0..* CodeableReference(Ingredient) The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly here --></ingredient>
 <impurity><!-- 0..* Reference(SubstanceDefinition) Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products --></impurity>
 <attachedDocument><!-- 0..* Reference(DocumentReference) Additional information or supporting documentation about the medicinal product --></attachedDocument>
 <masterFile><!-- 0..* Reference(DocumentReference) A master file for to 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>
 <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>
  <namePart>  <!-- 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>
  </namePart>
  <countryLanguage>  <!-- 0..* Country 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>
  </countryLanguage>
 </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, product to development product (investigational), parallel import version --></type>
 </crossReference>
 <operation>  <!-- 0..* A manufacturing or administrative process or step associated with (or performed on) the medicinal product -->
  <type><!-- 0..1 CodeableReference(ActivityDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute --></type>
  <effectiveDate><!-- 0..1 Period Date range of applicability --></effectiveDate>
  <organization><!-- 0..* Reference(Organization) The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent --></organization>
  <authorization><!-- 0..1 Reference(RegulatedAuthorization) An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a part --></authorization>
  <confidentialityIndicator><!-- 0..1 CodeableConcept Specifies whether this particular business or manufacturing process is considered proprietary or confidential --></confidentialityIndicator>
 </operation>
 <administrableProduct>  <!-- 0..* The product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable item -->
  <route><!-- 0..* CodeableConcept 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 --></route>
  <product><!-- 0..1 Reference(AdministrableProductDefinition) Full description of the administrable product --></product>
 </administrableProduct>
</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, this is commonly used to support revisions to an existing product
  "status" : { CodeableConcept }, // 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
  "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
  "indication" : "<markdown>", // 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 ClinicalUseIssue resource. An indication is a medical situation for which using the product is appropriate
  "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
  "paediatricUseIndicator" : { CodeableConcept }, // If authorised for use in children
  "classification" : [{ CodeableConcept }], // Allows the product to be classified by various systems
  "characteristic" : [{ CodeableConcept }], // Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"
  "marketingStatus" : [{ MarketingStatus }], // Marketing status of the medicinal product, in contrast to marketing authorization
  "packagedMedicinalProduct" : [{ CodeableReference(PackagedProductDefinition) }], // Package representation for the product
  "ingredient" : [{ CodeableReference(Ingredient) }], // The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly here
  "impurity" : [{ Reference(SubstanceDefinition) }], // Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products
  "attachedDocument" : [{ Reference(DocumentReference) }], // Additional information or supporting documentation about the medicinal product
  "masterFile" : [{ Reference(DocumentReference) }], // A master file for to 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
  "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
    "namePart" : [{ // 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)
    }],
    "countryLanguage" : [{ // Country 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, product to development product (investigational), parallel import version
  }],
  "operation" : [{ // A manufacturing or administrative process or step associated with (or performed on) the medicinal product
    "type" : { CodeableReference(ActivityDefinition) }, // The type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute
    "effectiveDate" : { Period }, // Date range of applicability
    "organization" : [{ Reference(Organization) }], // The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent
    "authorization" : { Reference(RegulatedAuthorization) }, // An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a part
    "confidentialityIndicator" : { CodeableConcept } // Specifies whether this particular business or manufacturing process is considered proprietary or confidential
  }],
  "administrableProduct" : [{ // The product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable item
    "route" : [{ CodeableConcept }], // 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
    "product" : { Reference(AdministrableProductDefinition) } // Full description of the administrable product
  }]
}

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, this is commonly used to support revisions to an existing product
  fhir:MedicinalProductDefinition.status [ CodeableConcept ]; # 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
  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.indication [ markdown ]; # 0..1 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 ClinicalUseIssue resource. An indication is a medical situation for which using the product is appropriate
  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.paediatricUseIndicator [ 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.characteristic [ CodeableConcept ], ... ; # 0..* Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"
  fhir:MedicinalProductDefinition.marketingStatus [ MarketingStatus ], ... ; # 0..* Marketing status of the medicinal product, in contrast to marketing authorization
  fhir:MedicinalProductDefinition.packagedMedicinalProduct [ CodeableReference(PackagedProductDefinition) ], ... ; # 0..* Package representation for the product
  fhir:MedicinalProductDefinition.ingredient [ CodeableReference(Ingredient) ], ... ; # 0..* The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly here
  fhir:MedicinalProductDefinition.impurity [ Reference(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. This includes process-related impurities and contaminants, product-related impurities including degradation products
  fhir:MedicinalProductDefinition.attachedDocument [ Reference(DocumentReference) ], ... ; # 0..* Additional information or supporting documentation about the medicinal product
  fhir:MedicinalProductDefinition.masterFile [ Reference(DocumentReference) ], ... ; # 0..* A master file for to 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.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.namePart [ # 0..* Coding words or phrases of the name
      fhir:MedicinalProductDefinition.name.namePart.part [ string ]; # 1..1 A fragment of a product name
      fhir:MedicinalProductDefinition.name.namePart.type [ CodeableConcept ]; # 1..1 Identifying type for this part of the name (e.g. strength part)
    ], ...;
    fhir:MedicinalProductDefinition.name.countryLanguage [ # 0..* Country where the name applies
      fhir:MedicinalProductDefinition.name.countryLanguage.country [ CodeableConcept ]; # 1..1 Country code for where this name applies
      fhir:MedicinalProductDefinition.name.countryLanguage.jurisdiction [ CodeableConcept ]; # 0..1 Jurisdiction code for where this name applies
      fhir:MedicinalProductDefinition.name.countryLanguage.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, product to development product (investigational), parallel import version
  ], ...;
  fhir:MedicinalProductDefinition.operation [ # 0..* A manufacturing or administrative process or step associated with (or performed on) the medicinal product
    fhir:MedicinalProductDefinition.operation.type [ CodeableReference(ActivityDefinition) ]; # 0..1 The type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute
    fhir:MedicinalProductDefinition.operation.effectiveDate [ Period ]; # 0..1 Date range of applicability
    fhir:MedicinalProductDefinition.operation.organization [ Reference(Organization) ], ... ; # 0..* The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent
    fhir:MedicinalProductDefinition.operation.authorization [ Reference(RegulatedAuthorization) ]; # 0..1 An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a part
    fhir:MedicinalProductDefinition.operation.confidentialityIndicator [ CodeableConcept ]; # 0..1 Specifies whether this particular business or manufacturing process is considered proprietary or confidential
  ], ...;
  fhir:MedicinalProductDefinition.administrableProduct [ # 0..* The product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable item
    fhir:MedicinalProductDefinition.administrableProduct.route [ CodeableConcept ], ... ; # 0..* 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
    fhir:MedicinalProductDefinition.administrableProduct.product [ Reference(AdministrableProductDefinition) ]; # 0..1 Full description of the administrable product
  ], ...;
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition ΣTUDomainResourceDetailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use, drug catalogs)
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
... domain Σ0..1CodeableConceptIf this medicine applies to human or veterinary uses
... version Σ0..1stringA business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product
... status Σ0..1CodeableConceptThe status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status
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
... indication Σ0..1markdownDescription 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 ClinicalUseIssue resource. An indication is a medical situation for which using the product is appropriate
... legalStatusOfSupply Σ0..1CodeableConceptThe legal status of supply of the medicinal product as classified by the regulator
... additionalMonitoringIndicator Σ0..1CodeableConceptWhether the Medicinal Product is subject to additional monitoring for regulatory reasons
... specialMeasures Σ0..*CodeableConceptWhether the Medicinal Product is subject to special measures for regulatory reasons
... paediatricUseIndicator Σ0..1CodeableConceptIf authorised for use in children
... classification Σ0..*CodeableConceptAllows the product to be classified by various systems
... characteristic Σ0..*CodeableConceptAllows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"
... marketingStatus Σ0..*MarketingStatusMarketing status of the medicinal product, in contrast to marketing authorization
... packagedMedicinalProduct Σ0..*CodeableReference(PackagedProductDefinition)Package representation for the product
... ingredient Σ0..*CodeableReference(Ingredient)The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly here
... impurity Σ0..*Reference(SubstanceDefinition)Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products
... attachedDocument Σ0..*Reference(DocumentReference)Additional information or supporting documentation about the medicinal product
... masterFile Σ0..*Reference(DocumentReference)A master file for to 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
.... 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
... 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
.... namePart 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)
.... countryLanguage Σ0..*BackboneElementCountry where the name applies
..... country Σ1..1CodeableConceptCountry code for where this name applies
..... jurisdiction Σ0..1CodeableConceptJurisdiction code for where this name applies
..... language Σ1..1CodeableConceptLanguage code for this name
... 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, product to development product (investigational), parallel import version
... operation Σ0..*BackboneElementA manufacturing or administrative process or step associated with (or performed on) the medicinal product
.... type Σ0..1CodeableReference(ActivityDefinition)The type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute
.... effectiveDate Σ0..1PeriodDate range of applicability
.... organization Σ0..*Reference(Organization)The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent
.... authorization Σ0..1Reference(RegulatedAuthorization)An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a part
.... confidentialityIndicator Σ0..1CodeableConceptSpecifies whether this particular business or manufacturing process is considered proprietary or confidential
... administrableProduct Σ0..*BackboneElementThe product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable item
.... route Σ0..*CodeableConceptThe 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
.... product Σ0..1Reference(AdministrableProductDefinition)Full description of the administrable product

doco Documentation for this format

UML Diagram (Legend)

MedicinalProductDefinition (DomainResource)Business identifier for this product. Could be an MPIDidentifier : Identifier [0..*]Regulatory type, e.g. Investigational or Authorizedtype : CodeableConcept [0..1]If this medicine applies to human or veterinary usesdomain : CodeableConcept [0..1]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 statusstatus : CodeableConcept [0..1] « Identifies the level of importance to be assigned to actioning the request. (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 productcombinedPharmaceuticalDoseForm : CodeableConcept [0..1]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 ClinicalUseIssue 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]Whether the Medicinal Product is subject to additional monitoring for regulatory reasonsadditionalMonitoringIndicator : CodeableConcept [0..1]Whether the Medicinal Product is subject to special measures for regulatory reasonsspecialMeasures : CodeableConcept [0..*]If authorised for use in childrenpaediatricUseIndicator : CodeableConcept [0..1]Allows the product to be classified by various systemsclassification : CodeableConcept [0..*]Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"characteristic : CodeableConcept [0..*]Marketing status of the medicinal product, in contrast to marketing authorizationmarketingStatus : MarketingStatus [0..*]Package representation for the productpackagedMedicinalProduct : DataType [0..*] « PackagedProductDefinition »The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly hereingredient : DataType [0..*] « Ingredient »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 : Reference [0..*] « SubstanceDefinition »Additional information or supporting documentation about the medicinal productattachedDocument : Reference [0..*] « DocumentReference »A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)masterFile : Reference [0..*] « DocumentReference »Clinical trials or studies that this product is involved inclinicalTrial : Reference [0..*] « ResearchStudy »ContactAllows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Informationtype : CodeableConcept [0..1]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]NamePartA fragment of a product namepart : string [1..1]Identifying type for this part of the name (e.g. strength part)type : CodeableConcept [1..1]CountryLanguageCountry code for where this name appliescountry : CodeableConcept [1..1]Jurisdiction code for where this name appliesjurisdiction : CodeableConcept [0..1]Language code for this namelanguage : CodeableConcept [1..1]CrossReferenceReference to another product, e.g. for linking authorised to investigational productproduct : DataType [1..1] « MedicinalProductDefinition »The type of relationship, for instance branded to generic, product to development product (investigational), parallel import versiontype : CodeableConcept [0..1]OperationThe type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attributetype : DataType [0..1] « ActivityDefinition »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 »An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a partauthorization : Reference [0..1] « RegulatedAuthorization »Specifies whether this particular business or manufacturing process is considered proprietary or confidentialconfidentialityIndicator : CodeableConcept [0..1]AdministrableProductThe 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 routeroute : CodeableConcept [0..*]Full description of the administrable productproduct : Reference [0..1] « AdministrableProductDefinition »A product specific contact, person (in a role), or an organizationcontact[0..*]Coding words or phrases of the namenamePart[0..*]Country where the name appliescountryLanguage[0..*]The product's name, including full name and possibly coded partsname[1..*]Reference to another product, e.g. for linking authorised to investigational productcrossReference[0..*]A manufacturing or administrative process or step associated with (or performed on) the medicinal productoperation[0..*]The product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable itemadministrableProduct[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, this is commonly used to support revisions to an existing product -->
 <status><!-- 0..1 CodeableConcept 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 --></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>
 <indication value="[markdown]"/><!-- 0..1 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 ClinicalUseIssue resource. An indication is a medical situation for which using the product is appropriate -->
 <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>
 <paediatricUseIndicator><!-- 0..1 CodeableConcept If authorised for use in children --></paediatricUseIndicator>
 <classification><!-- 0..* CodeableConcept Allows the product to be classified by various systems --></classification>
 <characteristic><!-- 0..* CodeableConcept Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import" --></characteristic>
 <marketingStatus><!-- 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization --></marketingStatus>
 <packagedMedicinalProduct><!-- 0..* CodeableReference(PackagedProductDefinition) Package representation for the product --></packagedMedicinalProduct>
 <ingredient><!-- 0..* CodeableReference(Ingredient) The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly here --></ingredient>
 <impurity><!-- 0..* Reference(SubstanceDefinition) Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products --></impurity>
 <attachedDocument><!-- 0..* Reference(DocumentReference) Additional information or supporting documentation about the medicinal product --></attachedDocument>
 <masterFile><!-- 0..* Reference(DocumentReference) A master file for to 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>
 <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>
  <namePart>  <!-- 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>
  </namePart>
  <countryLanguage>  <!-- 0..* Country 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>
  </countryLanguage>
 </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, product to development product (investigational), parallel import version --></type>
 </crossReference>
 <operation>  <!-- 0..* A manufacturing or administrative process or step associated with (or performed on) the medicinal product -->
  <type><!-- 0..1 CodeableReference(ActivityDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute --></type>
  <effectiveDate><!-- 0..1 Period Date range of applicability --></effectiveDate>
  <organization><!-- 0..* Reference(Organization) The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent --></organization>
  <authorization><!-- 0..1 Reference(RegulatedAuthorization) An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a part --></authorization>
  <confidentialityIndicator><!-- 0..1 CodeableConcept Specifies whether this particular business or manufacturing process is considered proprietary or confidential --></confidentialityIndicator>
 </operation>
 <administrableProduct>  <!-- 0..* The product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable item -->
  <route><!-- 0..* CodeableConcept 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 --></route>
  <product><!-- 0..1 Reference(AdministrableProductDefinition) Full description of the administrable product --></product>
 </administrableProduct>
</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, this is commonly used to support revisions to an existing product
  "status" : { CodeableConcept }, // 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
  "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
  "indication" : "<markdown>", // 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 ClinicalUseIssue resource. An indication is a medical situation for which using the product is appropriate
  "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
  "paediatricUseIndicator" : { CodeableConcept }, // If authorised for use in children
  "classification" : [{ CodeableConcept }], // Allows the product to be classified by various systems
  "characteristic" : [{ CodeableConcept }], // Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"
  "marketingStatus" : [{ MarketingStatus }], // Marketing status of the medicinal product, in contrast to marketing authorization
  "packagedMedicinalProduct" : [{ CodeableReference(PackagedProductDefinition) }], // Package representation for the product
  "ingredient" : [{ CodeableReference(Ingredient) }], // The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly here
  "impurity" : [{ Reference(SubstanceDefinition) }], // Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products
  "attachedDocument" : [{ Reference(DocumentReference) }], // Additional information or supporting documentation about the medicinal product
  "masterFile" : [{ Reference(DocumentReference) }], // A master file for to 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
  "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
    "namePart" : [{ // 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)
    }],
    "countryLanguage" : [{ // Country 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, product to development product (investigational), parallel import version
  }],
  "operation" : [{ // A manufacturing or administrative process or step associated with (or performed on) the medicinal product
    "type" : { CodeableReference(ActivityDefinition) }, // The type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute
    "effectiveDate" : { Period }, // Date range of applicability
    "organization" : [{ Reference(Organization) }], // The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent
    "authorization" : { Reference(RegulatedAuthorization) }, // An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a part
    "confidentialityIndicator" : { CodeableConcept } // Specifies whether this particular business or manufacturing process is considered proprietary or confidential
  }],
  "administrableProduct" : [{ // The product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable item
    "route" : [{ CodeableConcept }], // 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
    "product" : { Reference(AdministrableProductDefinition) } // Full description of the administrable product
  }]
}

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, this is commonly used to support revisions to an existing product
  fhir:MedicinalProductDefinition.status [ CodeableConcept ]; # 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
  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.indication [ markdown ]; # 0..1 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 ClinicalUseIssue resource. An indication is a medical situation for which using the product is appropriate
  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.paediatricUseIndicator [ 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.characteristic [ CodeableConcept ], ... ; # 0..* Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"
  fhir:MedicinalProductDefinition.marketingStatus [ MarketingStatus ], ... ; # 0..* Marketing status of the medicinal product, in contrast to marketing authorization
  fhir:MedicinalProductDefinition.packagedMedicinalProduct [ CodeableReference(PackagedProductDefinition) ], ... ; # 0..* Package representation for the product
  fhir:MedicinalProductDefinition.ingredient [ CodeableReference(Ingredient) ], ... ; # 0..* The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly here
  fhir:MedicinalProductDefinition.impurity [ Reference(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. This includes process-related impurities and contaminants, product-related impurities including degradation products
  fhir:MedicinalProductDefinition.attachedDocument [ Reference(DocumentReference) ], ... ; # 0..* Additional information or supporting documentation about the medicinal product
  fhir:MedicinalProductDefinition.masterFile [ Reference(DocumentReference) ], ... ; # 0..* A master file for to 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.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.namePart [ # 0..* Coding words or phrases of the name
      fhir:MedicinalProductDefinition.name.namePart.part [ string ]; # 1..1 A fragment of a product name
      fhir:MedicinalProductDefinition.name.namePart.type [ CodeableConcept ]; # 1..1 Identifying type for this part of the name (e.g. strength part)
    ], ...;
    fhir:MedicinalProductDefinition.name.countryLanguage [ # 0..* Country where the name applies
      fhir:MedicinalProductDefinition.name.countryLanguage.country [ CodeableConcept ]; # 1..1 Country code for where this name applies
      fhir:MedicinalProductDefinition.name.countryLanguage.jurisdiction [ CodeableConcept ]; # 0..1 Jurisdiction code for where this name applies
      fhir:MedicinalProductDefinition.name.countryLanguage.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, product to development product (investigational), parallel import version
  ], ...;
  fhir:MedicinalProductDefinition.operation [ # 0..* A manufacturing or administrative process or step associated with (or performed on) the medicinal product
    fhir:MedicinalProductDefinition.operation.type [ CodeableReference(ActivityDefinition) ]; # 0..1 The type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute
    fhir:MedicinalProductDefinition.operation.effectiveDate [ Period ]; # 0..1 Date range of applicability
    fhir:MedicinalProductDefinition.operation.organization [ Reference(Organization) ], ... ; # 0..* The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent
    fhir:MedicinalProductDefinition.operation.authorization [ Reference(RegulatedAuthorization) ]; # 0..1 An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a part
    fhir:MedicinalProductDefinition.operation.confidentialityIndicator [ CodeableConcept ]; # 0..1 Specifies whether this particular business or manufacturing process is considered proprietary or confidential
  ], ...;
  fhir:MedicinalProductDefinition.administrableProduct [ # 0..* The product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable item
    fhir:MedicinalProductDefinition.administrableProduct.route [ CodeableConcept ], ... ; # 0..* 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
    fhir:MedicinalProductDefinition.administrableProduct.product [ Reference(AdministrableProductDefinition) ]; # 0..1 Full description of the administrable product
  ], ...;
]

Changes since Release 3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

 

See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis a

PathDefinitionTypeReference
MedicinalProductDefinition.status Identifies the level of importance to be assigned to actioning the request.PreferredPublicationStatus

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
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 DreferenceReference to a resource (by instance)MedicinalProductDefinition.ingredient.reference
ingredient-code DtokenReference to a concept (by class)MedicinalProductDefinition.ingredient.concept
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.countryLanguage.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