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11.11 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).

Any pharmaceutical product or combination of pharmaceutical products that may be administered to human beings (or animals) for treating or preventing disease, with the aim/purpose of making a medical diagnosis or to restore, correct or modify physiological functions.

A Medicinal Product may contain in the packaging one or more manufactured items and one or more pharmaceutical products. In certain regions a Medicinal Product may also be defined as any substance or combination of substances which may be used to make a medical diagnosis.

This applies to proprietary medicinal products for human use intended to be placed on the market and to industrially manufactured medicinal products, the marketing of which has been authorised by a Medicines Regulatory Agency. However, the provisions do not apply to: i) medicinal products prepared according to prescription (e.g. prepared in a pharmacy from a prescription intended for a specific patient), ii) medicinal products prepared in accordance with an official formula (e.g. prepared in a pharmacy in accordance with the instructions in a pharmacopoeia and intended to be given direct to the patient by the pharmacy), iii) medicinal products intended for research and development trials (see 11.2 Investigational Medicinal Product) and to iv) intermediate products intended for subsequent processing by an authorised manufacturer. [from ENV 13607 and ENV 12610]

This resource is referenced by AdministrableProductDefinition, ClinicalUseIssue, PackagedProductDefinition 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)
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..1CodingIf this medicine applies to human or veterinary uses
... description Σ0..1stringGeneral description of this product
... combinedPharmaceuticalDoseForm Σ0..1CodeableConceptThe dose form for a single part product, or combined form of a multiple part product
... indication Σ0..1markdownGeneral combined description of indication(s) for this product. See also MedicinalProductDefinitionIndication
... 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
... productClassification Σ0..*CodeableConceptAllows the product to be classified by various systems
... marketingStatus Σ0..*MarketingStatusMarketing status of the medicinal product, in contrast to marketing authorizaton
... pharmaceuticalProduct Σ0..*Reference(AdministrableProductDefinition)Pharmaceutical aspects of product
... packagedMedicinalProduct Σ0..*Reference(PackagedProductDefinition)Package representation for the product
... ingredient Σ0..*Reference(Ingredient)The ingredients of this medicinal product - when not specified elsewhere. This is only needed if the ingredients are not specified by the pharmaceuticalProduct or packagedMedicinalProduct references above. In cases where those levels of detail are not used, the ingredients may be specified directly here
... attachedDocument Σ0..*Reference(DocumentReference)Supporting documentation, typically for regulatory submission
... 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, Pharmacovigilence 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..1CodingType of the product name, such as rINN or BAN
.... namePart Σ0..*BackboneElementCoding words or phrases of the name
..... part Σ1..1stringA fragment of a product name
..... type Σ1..1CodingIdenifying 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..*IdentifierReference to another product, e.g. for linking authorised to investigational product
... manufacturingBusinessOperation Σ0..*BackboneElementAn operation applied to the product, for manufacturing or adminsitrative purpose
.... operationType Σ0..1CodeableConceptThe type of manufacturing operation e.g. manufacturing itself, re-packaging
.... authorisationReferenceNumber Σ0..1IdentifierRegulatory authorization reference number
.... effectiveDate Σ0..1PeriodRegulatory authorization date
.... confidentialityIndicator Σ0..1CodeableConceptTo indicate if this proces is commercially confidential
.... manufacturer Σ0..*Reference(Organization)The manufacturer or establishment associated with the process
.... regulator Σ0..1Reference(Organization)A regulator which oversees the operation
... specialDesignation Σ0..*BackboneElementIndicates if the medicinal product has an orphan designation for the treatment of a rare disease
.... identifier Σ0..*IdentifierIdentifier for the designation, or procedure number
.... type Σ0..1CodeableConceptThe type of special designation, e.g. orphan drug, minor use
.... intendedUse Σ0..1CodeableConceptThe intended use of the product, e.g. prevention, treatment
.... indication[x] Σ0..1Condition for which the medicinal use applies
..... indicationCodeableConceptCodeableConcept
..... indicationReferenceReference(ClinicalUseIssue)
.... status Σ0..1CodeableConceptFor example granted, pending, expired or withdrawn
.... date Σ0..1dateTimeDate when the designation was granted
.... species Σ0..1CodeableConceptAnimal species for which this applies

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 : Coding [0..1]General description of this productdescription : string [0..1]The dose form for a single part product, or combined form of a multiple part productcombinedPharmaceuticalDoseForm : CodeableConcept [0..1]General combined description of indication(s) for this product. See also MedicinalProductDefinitionIndicationindication : 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 systemsproductClassification : CodeableConcept [0..*]Marketing status of the medicinal product, in contrast to marketing authorizatonmarketingStatus : MarketingStatus [0..*]Pharmaceutical aspects of productpharmaceuticalProduct : Reference [0..*] « AdministrableProductDefinition »Package representation for the productpackagedMedicinalProduct : Reference [0..*] « PackagedProductDefinition »The ingredients of this medicinal product - when not specified elsewhere. This is only needed if the ingredients are not specified by the pharmaceuticalProduct or packagedMedicinalProduct references above. In cases where those levels of detail are not used, the ingredients may be specified directly hereingredient : Reference [0..*] « Ingredient »Supporting documentation, typically for regulatory submissionattachedDocument : 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 »Reference to another product, e.g. for linking authorised to investigational productcrossReference : Identifier [0..*]ContactAllows the contact to be classified, for example QPPV, Pharmacovigilence 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 the product name, such as rINN or BANtype : Coding [0..1]NamePartA fragment of a product namepart : string [1..1]Idenifying type for this part of the name (e.g. strength part)type : Coding [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]ManufacturingBusinessOperationThe type of manufacturing operation e.g. manufacturing itself, re-packagingoperationType : CodeableConcept [0..1]Regulatory authorization reference numberauthorisationReferenceNumber : Identifier [0..1]Regulatory authorization dateeffectiveDate : Period [0..1]To indicate if this proces is commercially confidentialconfidentialityIndicator : CodeableConcept [0..1]The manufacturer or establishment associated with the processmanufacturer : Reference [0..*] « Organization »A regulator which oversees the operationregulator : Reference [0..1] « Organization »SpecialDesignationIdentifier for the designation, or procedure numberidentifier : Identifier [0..*]The type of special designation, e.g. orphan drug, minor usetype : CodeableConcept [0..1]The intended use of the product, e.g. prevention, treatmentintendedUse : CodeableConcept [0..1]Condition for which the medicinal use appliesindication[x] : Type [0..1] « CodeableConcept|Reference( ClinicalUseIssue) »For example granted, pending, expired or withdrawnstatus : CodeableConcept [0..1]Date when the designation was granteddate : dateTime [0..1]Animal species for which this appliesspecies : CodeableConcept [0..1]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..*]An operation applied to the product, for manufacturing or adminsitrative purposemanufacturingBusinessOperation[0..*]Indicates if the medicinal product has an orphan designation for the treatment of a rare diseasespecialDesignation[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 Coding If this medicine applies to human or veterinary uses --></domain>
 <description value="[string]"/><!-- 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 General combined description of indication(s) for this product. See also MedicinalProductDefinitionIndication -->
 <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>
 <productClassification><!-- 0..* CodeableConcept Allows the product to be classified by various systems --></productClassification>
 <marketingStatus><!-- 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorizaton --></marketingStatus>
 <pharmaceuticalProduct><!-- 0..* Reference(AdministrableProductDefinition) Pharmaceutical aspects of product --></pharmaceuticalProduct>
 <packagedMedicinalProduct><!-- 0..* Reference(PackagedProductDefinition) Package representation for the product --></packagedMedicinalProduct>
 <ingredient><!-- 0..* Reference(Ingredient) The ingredients of this medicinal product - when not specified elsewhere. This is only needed if the ingredients are not specified by the pharmaceuticalProduct or packagedMedicinalProduct references above. In cases where those levels of detail are not used, the ingredients may be specified directly here --></ingredient>
 <attachedDocument><!-- 0..* Reference(DocumentReference) Supporting documentation, typically for regulatory submission --></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, Pharmacovigilence 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 Coding Type of the product name, such as rINN or BAN --></type>
  <namePart>  <!-- 0..* Coding words or phrases of the name -->
   <part value="[string]"/><!-- 1..1 A fragment of a product name -->
   <type><!-- 1..1 Coding Idenifying 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..* Identifier Reference to another product, e.g. for linking authorised to investigational product --></crossReference>
 <manufacturingBusinessOperation>  <!-- 0..* An operation applied to the product, for manufacturing or adminsitrative purpose -->
  <operationType><!-- 0..1 CodeableConcept The type of manufacturing operation e.g. manufacturing itself, re-packaging --></operationType>
  <authorisationReferenceNumber><!-- 0..1 Identifier Regulatory authorization reference number --></authorisationReferenceNumber>
  <effectiveDate><!-- 0..1 Period Regulatory authorization date --></effectiveDate>
  <confidentialityIndicator><!-- 0..1 CodeableConcept To indicate if this proces is commercially confidential --></confidentialityIndicator>
  <manufacturer><!-- 0..* Reference(Organization) The manufacturer or establishment associated with the process --></manufacturer>
  <regulator><!-- 0..1 Reference(Organization) A regulator which oversees the operation --></regulator>
 </manufacturingBusinessOperation>
 <specialDesignation>  <!-- 0..* Indicates if the medicinal product has an orphan designation for the treatment of a rare disease -->
  <identifier><!-- 0..* Identifier Identifier for the designation, or procedure number --></identifier>
  <type><!-- 0..1 CodeableConcept The type of special designation, e.g. orphan drug, minor use --></type>
  <intendedUse><!-- 0..1 CodeableConcept The intended use of the product, e.g. prevention, treatment --></intendedUse>
  <indication[x]><!-- 0..1 CodeableConcept|Reference(ClinicalUseIssue) Condition for which the medicinal use applies --></indication[x]>
  <status><!-- 0..1 CodeableConcept For example granted, pending, expired or withdrawn --></status>
  <date value="[dateTime]"/><!-- 0..1 Date when the designation was granted -->
  <species><!-- 0..1 CodeableConcept Animal species for which this applies --></species>
 </specialDesignation>
</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" : { Coding }, // If this medicine applies to human or veterinary uses
  "description" : "<string>", // 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>", // General combined description of indication(s) for this product. See also MedicinalProductDefinitionIndication
  "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
  "productClassification" : [{ CodeableConcept }], // Allows the product to be classified by various systems
  "marketingStatus" : [{ MarketingStatus }], // Marketing status of the medicinal product, in contrast to marketing authorizaton
  "pharmaceuticalProduct" : [{ Reference(AdministrableProductDefinition) }], // Pharmaceutical aspects of product
  "packagedMedicinalProduct" : [{ Reference(PackagedProductDefinition) }], // Package representation for the product
  "ingredient" : [{ Reference(Ingredient) }], // The ingredients of this medicinal product - when not specified elsewhere. This is only needed if the ingredients are not specified by the pharmaceuticalProduct or packagedMedicinalProduct references above. In cases where those levels of detail are not used, the ingredients may be specified directly here
  "attachedDocument" : [{ Reference(DocumentReference) }], // Supporting documentation, typically for regulatory submission
  "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, Pharmacovigilence 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" : { Coding }, // Type of the product name, such as rINN or BAN
    "namePart" : [{ // Coding words or phrases of the name
      "part" : "<string>", // R!  A fragment of a product name
      "type" : { Coding } // R!  Idenifying 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" : [{ Identifier }], // Reference to another product, e.g. for linking authorised to investigational product
  "manufacturingBusinessOperation" : [{ // An operation applied to the product, for manufacturing or adminsitrative purpose
    "operationType" : { CodeableConcept }, // The type of manufacturing operation e.g. manufacturing itself, re-packaging
    "authorisationReferenceNumber" : { Identifier }, // Regulatory authorization reference number
    "effectiveDate" : { Period }, // Regulatory authorization date
    "confidentialityIndicator" : { CodeableConcept }, // To indicate if this proces is commercially confidential
    "manufacturer" : [{ Reference(Organization) }], // The manufacturer or establishment associated with the process
    "regulator" : { Reference(Organization) } // A regulator which oversees the operation
  }],
  "specialDesignation" : [{ // Indicates if the medicinal product has an orphan designation for the treatment of a rare disease
    "identifier" : [{ Identifier }], // Identifier for the designation, or procedure number
    "type" : { CodeableConcept }, // The type of special designation, e.g. orphan drug, minor use
    "intendedUse" : { CodeableConcept }, // The intended use of the product, e.g. prevention, treatment
    // indication[x]: Condition for which the medicinal use applies. One of these 2:
    "indicationCodeableConcept" : { CodeableConcept },
    "indicationReference" : { Reference(ClinicalUseIssue) },
    "status" : { CodeableConcept }, // For example granted, pending, expired or withdrawn
    "date" : "<dateTime>", // Date when the designation was granted
    "species" : { CodeableConcept } // Animal species for which this applies
  }]
}

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 [ Coding ]; # 0..1 If this medicine applies to human or veterinary uses
  fhir:MedicinalProductDefinition.description [ string ]; # 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 General combined description of indication(s) for this product. See also MedicinalProductDefinitionIndication
  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.productClassification [ 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 authorizaton
  fhir:MedicinalProductDefinition.pharmaceuticalProduct [ Reference(AdministrableProductDefinition) ], ... ; # 0..* Pharmaceutical aspects of product
  fhir:MedicinalProductDefinition.packagedMedicinalProduct [ Reference(PackagedProductDefinition) ], ... ; # 0..* Package representation for the product
  fhir:MedicinalProductDefinition.ingredient [ Reference(Ingredient) ], ... ; # 0..* The ingredients of this medicinal product - when not specified elsewhere. This is only needed if the ingredients are not specified by the pharmaceuticalProduct or packagedMedicinalProduct references above. In cases where those levels of detail are not used, the ingredients may be specified directly here
  fhir:MedicinalProductDefinition.attachedDocument [ Reference(DocumentReference) ], ... ; # 0..* Supporting documentation, typically for regulatory submission
  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, Pharmacovigilence 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 [ Coding ]; # 0..1 Type of the product name, such as rINN or BAN
    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 [ Coding ]; # 1..1 Idenifying 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 [ Identifier ], ... ; # 0..* Reference to another product, e.g. for linking authorised to investigational product
  fhir:MedicinalProductDefinition.manufacturingBusinessOperation [ # 0..* An operation applied to the product, for manufacturing or adminsitrative purpose
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.operationType [ CodeableConcept ]; # 0..1 The type of manufacturing operation e.g. manufacturing itself, re-packaging
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.authorisationReferenceNumber [ Identifier ]; # 0..1 Regulatory authorization reference number
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.effectiveDate [ Period ]; # 0..1 Regulatory authorization date
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.confidentialityIndicator [ CodeableConcept ]; # 0..1 To indicate if this proces is commercially confidential
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.manufacturer [ Reference(Organization) ], ... ; # 0..* The manufacturer or establishment associated with the process
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.regulator [ Reference(Organization) ]; # 0..1 A regulator which oversees the operation
  ], ...;
  fhir:MedicinalProductDefinition.specialDesignation [ # 0..* Indicates if the medicinal product has an orphan designation for the treatment of a rare disease
    fhir:MedicinalProductDefinition.specialDesignation.identifier [ Identifier ], ... ; # 0..* Identifier for the designation, or procedure number
    fhir:MedicinalProductDefinition.specialDesignation.type [ CodeableConcept ]; # 0..1 The type of special designation, e.g. orphan drug, minor use
    fhir:MedicinalProductDefinition.specialDesignation.intendedUse [ CodeableConcept ]; # 0..1 The intended use of the product, e.g. prevention, treatment
    # MedicinalProductDefinition.specialDesignation.indication[x] : 0..1 Condition for which the medicinal use applies. One of these 2
      fhir:MedicinalProductDefinition.specialDesignation.indicationCodeableConcept [ CodeableConcept ]
      fhir:MedicinalProductDefinition.specialDesignation.indicationReference [ Reference(ClinicalUseIssue) ]
    fhir:MedicinalProductDefinition.specialDesignation.status [ CodeableConcept ]; # 0..1 For example granted, pending, expired or withdrawn
    fhir:MedicinalProductDefinition.specialDesignation.date [ dateTime ]; # 0..1 Date when the designation was granted
    fhir:MedicinalProductDefinition.specialDesignation.species [ CodeableConcept ]; # 0..1 Animal species for which this applies
  ], ...;
]

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)
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..1CodingIf this medicine applies to human or veterinary uses
... description Σ0..1stringGeneral description of this product
... combinedPharmaceuticalDoseForm Σ0..1CodeableConceptThe dose form for a single part product, or combined form of a multiple part product
... indication Σ0..1markdownGeneral combined description of indication(s) for this product. See also MedicinalProductDefinitionIndication
... 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
... productClassification Σ0..*CodeableConceptAllows the product to be classified by various systems
... marketingStatus Σ0..*MarketingStatusMarketing status of the medicinal product, in contrast to marketing authorizaton
... pharmaceuticalProduct Σ0..*Reference(AdministrableProductDefinition)Pharmaceutical aspects of product
... packagedMedicinalProduct Σ0..*Reference(PackagedProductDefinition)Package representation for the product
... ingredient Σ0..*Reference(Ingredient)The ingredients of this medicinal product - when not specified elsewhere. This is only needed if the ingredients are not specified by the pharmaceuticalProduct or packagedMedicinalProduct references above. In cases where those levels of detail are not used, the ingredients may be specified directly here
... attachedDocument Σ0..*Reference(DocumentReference)Supporting documentation, typically for regulatory submission
... 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, Pharmacovigilence 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..1CodingType of the product name, such as rINN or BAN
.... namePart Σ0..*BackboneElementCoding words or phrases of the name
..... part Σ1..1stringA fragment of a product name
..... type Σ1..1CodingIdenifying 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..*IdentifierReference to another product, e.g. for linking authorised to investigational product
... manufacturingBusinessOperation Σ0..*BackboneElementAn operation applied to the product, for manufacturing or adminsitrative purpose
.... operationType Σ0..1CodeableConceptThe type of manufacturing operation e.g. manufacturing itself, re-packaging
.... authorisationReferenceNumber Σ0..1IdentifierRegulatory authorization reference number
.... effectiveDate Σ0..1PeriodRegulatory authorization date
.... confidentialityIndicator Σ0..1CodeableConceptTo indicate if this proces is commercially confidential
.... manufacturer Σ0..*Reference(Organization)The manufacturer or establishment associated with the process
.... regulator Σ0..1Reference(Organization)A regulator which oversees the operation
... specialDesignation Σ0..*BackboneElementIndicates if the medicinal product has an orphan designation for the treatment of a rare disease
.... identifier Σ0..*IdentifierIdentifier for the designation, or procedure number
.... type Σ0..1CodeableConceptThe type of special designation, e.g. orphan drug, minor use
.... intendedUse Σ0..1CodeableConceptThe intended use of the product, e.g. prevention, treatment
.... indication[x] Σ0..1Condition for which the medicinal use applies
..... indicationCodeableConceptCodeableConcept
..... indicationReferenceReference(ClinicalUseIssue)
.... status Σ0..1CodeableConceptFor example granted, pending, expired or withdrawn
.... date Σ0..1dateTimeDate when the designation was granted
.... species Σ0..1CodeableConceptAnimal species for which this applies

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 : Coding [0..1]General description of this productdescription : string [0..1]The dose form for a single part product, or combined form of a multiple part productcombinedPharmaceuticalDoseForm : CodeableConcept [0..1]General combined description of indication(s) for this product. See also MedicinalProductDefinitionIndicationindication : 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 systemsproductClassification : CodeableConcept [0..*]Marketing status of the medicinal product, in contrast to marketing authorizatonmarketingStatus : MarketingStatus [0..*]Pharmaceutical aspects of productpharmaceuticalProduct : Reference [0..*] « AdministrableProductDefinition »Package representation for the productpackagedMedicinalProduct : Reference [0..*] « PackagedProductDefinition »The ingredients of this medicinal product - when not specified elsewhere. This is only needed if the ingredients are not specified by the pharmaceuticalProduct or packagedMedicinalProduct references above. In cases where those levels of detail are not used, the ingredients may be specified directly hereingredient : Reference [0..*] « Ingredient »Supporting documentation, typically for regulatory submissionattachedDocument : 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 »Reference to another product, e.g. for linking authorised to investigational productcrossReference : Identifier [0..*]ContactAllows the contact to be classified, for example QPPV, Pharmacovigilence 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 the product name, such as rINN or BANtype : Coding [0..1]NamePartA fragment of a product namepart : string [1..1]Idenifying type for this part of the name (e.g. strength part)type : Coding [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]ManufacturingBusinessOperationThe type of manufacturing operation e.g. manufacturing itself, re-packagingoperationType : CodeableConcept [0..1]Regulatory authorization reference numberauthorisationReferenceNumber : Identifier [0..1]Regulatory authorization dateeffectiveDate : Period [0..1]To indicate if this proces is commercially confidentialconfidentialityIndicator : CodeableConcept [0..1]The manufacturer or establishment associated with the processmanufacturer : Reference [0..*] « Organization »A regulator which oversees the operationregulator : Reference [0..1] « Organization »SpecialDesignationIdentifier for the designation, or procedure numberidentifier : Identifier [0..*]The type of special designation, e.g. orphan drug, minor usetype : CodeableConcept [0..1]The intended use of the product, e.g. prevention, treatmentintendedUse : CodeableConcept [0..1]Condition for which the medicinal use appliesindication[x] : Type [0..1] « CodeableConcept|Reference( ClinicalUseIssue) »For example granted, pending, expired or withdrawnstatus : CodeableConcept [0..1]Date when the designation was granteddate : dateTime [0..1]Animal species for which this appliesspecies : CodeableConcept [0..1]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..*]An operation applied to the product, for manufacturing or adminsitrative purposemanufacturingBusinessOperation[0..*]Indicates if the medicinal product has an orphan designation for the treatment of a rare diseasespecialDesignation[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 Coding If this medicine applies to human or veterinary uses --></domain>
 <description value="[string]"/><!-- 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 General combined description of indication(s) for this product. See also MedicinalProductDefinitionIndication -->
 <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>
 <productClassification><!-- 0..* CodeableConcept Allows the product to be classified by various systems --></productClassification>
 <marketingStatus><!-- 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorizaton --></marketingStatus>
 <pharmaceuticalProduct><!-- 0..* Reference(AdministrableProductDefinition) Pharmaceutical aspects of product --></pharmaceuticalProduct>
 <packagedMedicinalProduct><!-- 0..* Reference(PackagedProductDefinition) Package representation for the product --></packagedMedicinalProduct>
 <ingredient><!-- 0..* Reference(Ingredient) The ingredients of this medicinal product - when not specified elsewhere. This is only needed if the ingredients are not specified by the pharmaceuticalProduct or packagedMedicinalProduct references above. In cases where those levels of detail are not used, the ingredients may be specified directly here --></ingredient>
 <attachedDocument><!-- 0..* Reference(DocumentReference) Supporting documentation, typically for regulatory submission --></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, Pharmacovigilence 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 Coding Type of the product name, such as rINN or BAN --></type>
  <namePart>  <!-- 0..* Coding words or phrases of the name -->
   <part value="[string]"/><!-- 1..1 A fragment of a product name -->
   <type><!-- 1..1 Coding Idenifying 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..* Identifier Reference to another product, e.g. for linking authorised to investigational product --></crossReference>
 <manufacturingBusinessOperation>  <!-- 0..* An operation applied to the product, for manufacturing or adminsitrative purpose -->
  <operationType><!-- 0..1 CodeableConcept The type of manufacturing operation e.g. manufacturing itself, re-packaging --></operationType>
  <authorisationReferenceNumber><!-- 0..1 Identifier Regulatory authorization reference number --></authorisationReferenceNumber>
  <effectiveDate><!-- 0..1 Period Regulatory authorization date --></effectiveDate>
  <confidentialityIndicator><!-- 0..1 CodeableConcept To indicate if this proces is commercially confidential --></confidentialityIndicator>
  <manufacturer><!-- 0..* Reference(Organization) The manufacturer or establishment associated with the process --></manufacturer>
  <regulator><!-- 0..1 Reference(Organization) A regulator which oversees the operation --></regulator>
 </manufacturingBusinessOperation>
 <specialDesignation>  <!-- 0..* Indicates if the medicinal product has an orphan designation for the treatment of a rare disease -->
  <identifier><!-- 0..* Identifier Identifier for the designation, or procedure number --></identifier>
  <type><!-- 0..1 CodeableConcept The type of special designation, e.g. orphan drug, minor use --></type>
  <intendedUse><!-- 0..1 CodeableConcept The intended use of the product, e.g. prevention, treatment --></intendedUse>
  <indication[x]><!-- 0..1 CodeableConcept|Reference(ClinicalUseIssue) Condition for which the medicinal use applies --></indication[x]>
  <status><!-- 0..1 CodeableConcept For example granted, pending, expired or withdrawn --></status>
  <date value="[dateTime]"/><!-- 0..1 Date when the designation was granted -->
  <species><!-- 0..1 CodeableConcept Animal species for which this applies --></species>
 </specialDesignation>
</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" : { Coding }, // If this medicine applies to human or veterinary uses
  "description" : "<string>", // 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>", // General combined description of indication(s) for this product. See also MedicinalProductDefinitionIndication
  "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
  "productClassification" : [{ CodeableConcept }], // Allows the product to be classified by various systems
  "marketingStatus" : [{ MarketingStatus }], // Marketing status of the medicinal product, in contrast to marketing authorizaton
  "pharmaceuticalProduct" : [{ Reference(AdministrableProductDefinition) }], // Pharmaceutical aspects of product
  "packagedMedicinalProduct" : [{ Reference(PackagedProductDefinition) }], // Package representation for the product
  "ingredient" : [{ Reference(Ingredient) }], // The ingredients of this medicinal product - when not specified elsewhere. This is only needed if the ingredients are not specified by the pharmaceuticalProduct or packagedMedicinalProduct references above. In cases where those levels of detail are not used, the ingredients may be specified directly here
  "attachedDocument" : [{ Reference(DocumentReference) }], // Supporting documentation, typically for regulatory submission
  "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, Pharmacovigilence 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" : { Coding }, // Type of the product name, such as rINN or BAN
    "namePart" : [{ // Coding words or phrases of the name
      "part" : "<string>", // R!  A fragment of a product name
      "type" : { Coding } // R!  Idenifying 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" : [{ Identifier }], // Reference to another product, e.g. for linking authorised to investigational product
  "manufacturingBusinessOperation" : [{ // An operation applied to the product, for manufacturing or adminsitrative purpose
    "operationType" : { CodeableConcept }, // The type of manufacturing operation e.g. manufacturing itself, re-packaging
    "authorisationReferenceNumber" : { Identifier }, // Regulatory authorization reference number
    "effectiveDate" : { Period }, // Regulatory authorization date
    "confidentialityIndicator" : { CodeableConcept }, // To indicate if this proces is commercially confidential
    "manufacturer" : [{ Reference(Organization) }], // The manufacturer or establishment associated with the process
    "regulator" : { Reference(Organization) } // A regulator which oversees the operation
  }],
  "specialDesignation" : [{ // Indicates if the medicinal product has an orphan designation for the treatment of a rare disease
    "identifier" : [{ Identifier }], // Identifier for the designation, or procedure number
    "type" : { CodeableConcept }, // The type of special designation, e.g. orphan drug, minor use
    "intendedUse" : { CodeableConcept }, // The intended use of the product, e.g. prevention, treatment
    // indication[x]: Condition for which the medicinal use applies. One of these 2:
    "indicationCodeableConcept" : { CodeableConcept },
    "indicationReference" : { Reference(ClinicalUseIssue) },
    "status" : { CodeableConcept }, // For example granted, pending, expired or withdrawn
    "date" : "<dateTime>", // Date when the designation was granted
    "species" : { CodeableConcept } // Animal species for which this applies
  }]
}

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 [ Coding ]; # 0..1 If this medicine applies to human or veterinary uses
  fhir:MedicinalProductDefinition.description [ string ]; # 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 General combined description of indication(s) for this product. See also MedicinalProductDefinitionIndication
  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.productClassification [ 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 authorizaton
  fhir:MedicinalProductDefinition.pharmaceuticalProduct [ Reference(AdministrableProductDefinition) ], ... ; # 0..* Pharmaceutical aspects of product
  fhir:MedicinalProductDefinition.packagedMedicinalProduct [ Reference(PackagedProductDefinition) ], ... ; # 0..* Package representation for the product
  fhir:MedicinalProductDefinition.ingredient [ Reference(Ingredient) ], ... ; # 0..* The ingredients of this medicinal product - when not specified elsewhere. This is only needed if the ingredients are not specified by the pharmaceuticalProduct or packagedMedicinalProduct references above. In cases where those levels of detail are not used, the ingredients may be specified directly here
  fhir:MedicinalProductDefinition.attachedDocument [ Reference(DocumentReference) ], ... ; # 0..* Supporting documentation, typically for regulatory submission
  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, Pharmacovigilence 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 [ Coding ]; # 0..1 Type of the product name, such as rINN or BAN
    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 [ Coding ]; # 1..1 Idenifying 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 [ Identifier ], ... ; # 0..* Reference to another product, e.g. for linking authorised to investigational product
  fhir:MedicinalProductDefinition.manufacturingBusinessOperation [ # 0..* An operation applied to the product, for manufacturing or adminsitrative purpose
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.operationType [ CodeableConcept ]; # 0..1 The type of manufacturing operation e.g. manufacturing itself, re-packaging
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.authorisationReferenceNumber [ Identifier ]; # 0..1 Regulatory authorization reference number
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.effectiveDate [ Period ]; # 0..1 Regulatory authorization date
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.confidentialityIndicator [ CodeableConcept ]; # 0..1 To indicate if this proces is commercially confidential
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.manufacturer [ Reference(Organization) ], ... ; # 0..* The manufacturer or establishment associated with the process
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.regulator [ Reference(Organization) ]; # 0..1 A regulator which oversees the operation
  ], ...;
  fhir:MedicinalProductDefinition.specialDesignation [ # 0..* Indicates if the medicinal product has an orphan designation for the treatment of a rare disease
    fhir:MedicinalProductDefinition.specialDesignation.identifier [ Identifier ], ... ; # 0..* Identifier for the designation, or procedure number
    fhir:MedicinalProductDefinition.specialDesignation.type [ CodeableConcept ]; # 0..1 The type of special designation, e.g. orphan drug, minor use
    fhir:MedicinalProductDefinition.specialDesignation.intendedUse [ CodeableConcept ]; # 0..1 The intended use of the product, e.g. prevention, treatment
    # MedicinalProductDefinition.specialDesignation.indication[x] : 0..1 Condition for which the medicinal use applies. One of these 2
      fhir:MedicinalProductDefinition.specialDesignation.indicationCodeableConcept [ CodeableConcept ]
      fhir:MedicinalProductDefinition.specialDesignation.indicationReference [ Reference(ClinicalUseIssue) ]
    fhir:MedicinalProductDefinition.specialDesignation.status [ CodeableConcept ]; # 0..1 For example granted, pending, expired or withdrawn
    fhir:MedicinalProductDefinition.specialDesignation.date [ dateTime ]; # 0..1 Date when the designation was granted
    fhir:MedicinalProductDefinition.specialDesignation.species [ CodeableConcept ]; # 0..1 Animal species for which this applies
  ], ...;
]

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

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

NameTypeDescriptionExpressionIn Common
identifiertokenBusiness identifier for this product. Could be an MPIDMedicinalProductDefinition.identifier
namestringThe full product nameMedicinalProductDefinition.name.productName
name-languagetokenLanguage code for this nameMedicinalProductDefinition.name.countryLanguage.language