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11.11 Resource MedicinalProductDefinition - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 1

Trial Use

Security 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).

11.11.1 Scope and Usage

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]

11.11.2 References

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

This resource does not implement any patterns.

Structure

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition	Σ TU		DomainResource	Detailed 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	Σ	0..*	Identifier	Business identifier for this product. Could be an MPID
type	Σ	0..1	CodeableConcept	Regulatory type, e.g. Investigational or Authorized
domain	Σ	0..1	Coding	If this medicine applies to human or veterinary uses
version	Σ	0..1	string	A business level identifier of the product
status	Σ	0..1	Coding	The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization status PublicationStatus (Preferred)
description	Σ	0..1	markdown	General description of this product
combinedPharmaceuticalDoseForm	Σ	0..1	CodeableConcept	The dose form for a single part product, or combined form of a multiple part product
indication	Σ	0..1	markdown	General combined description of indication(s) for this product. See also MedicinalProductDefinitionIndication
legalStatusOfSupply	Σ	0..1	CodeableConcept	The legal status of supply of the medicinal product as classified by the regulator
additionalMonitoringIndicator	Σ	0..1	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
specialMeasures	Σ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons
paediatricUseIndicator	Σ	0..1	CodeableConcept	If authorised for use in children
productClassification	Σ	0..*	CodeableConcept	Allows the product to be classified by various systems
marketingStatus	Σ	0..*	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorizaton
pharmaceuticalProduct	Σ	0..*	Reference(AdministrableProductDefinition)	Pharmaceutical aspects of product
packagedMedicinalProduct	Σ	0..*	Reference(PackagedProductDefinition)	Package representation for the product
ingredient	Σ	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
attachedDocument	Σ	0..*	Reference(DocumentReference)	Supporting documentation, typically for regulatory submission
masterFile	Σ	0..*	Reference(DocumentReference)	A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
contact	Σ	0..*	BackboneElement	A product specific contact, person (in a role), or an organization
type	Σ	0..1	CodeableConcept	Allows the contact to be classified, for example QPPV, Pharmacovigilence Enquiry Information
contact	Σ	1..1	Reference(Organization \| PractitionerRole)	A product specific contact, person (in a role), or an organization
clinicalTrial	Σ	0..*	Reference(ResearchStudy)	Clinical trials or studies that this product is involved in
name	Σ	1..*	BackboneElement	The product's name, including full name and possibly coded parts
productName	Σ	1..1	string	The full product name
type	Σ	0..1	Coding	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
namePart	Σ	0..*	BackboneElement	Coding words or phrases of the name
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	Coding	Idenifying type for this part of the name (e.g. strength part)
countryLanguage	Σ	0..*	BackboneElement	Country where the name applies
country	Σ	1..1	CodeableConcept	Country code for where this name applies
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction code for where this name applies
language	Σ	1..1	CodeableConcept	Language code for this name
crossReference	Σ	0..*	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
product[x]	Σ	1..1		Reference to another product, e.g. for linking authorised to investigational product
productIdentifier			Identifier
productReference			Reference(MedicinalProductDefinition)
type	Σ	0..1	Coding	The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version
manufacturingBusinessOperation	Σ	0..*	BackboneElement	An operation applied to the product, for manufacturing or adminsitrative purpose
type[x]	Σ	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
typeCoding			Coding
typeReference			Reference(ActivityDefinition)
effectiveDate	Σ	0..1	Period	Date range of applicability
manufacturer	Σ	0..*	Reference(Organization)	The manufacturer or establishment associated with the process
authorization	Σ	0..1	Reference(RegulatedAuthorization)	An authorization for this process, either as a logical reference, holding just an identifier, or a full refererence to a resource that captures the details. The authorization mayu possibly apply to several products or a wider scope of process of which this is a part
confidentialityIndicator	Σ	0..1	CodeableConcept	To indicate if this proces is commercially confidential
Documentation for this format

UML Diagram (Legend)

XML Template

<MedicinalProductDefinition xmlns="http://hl7.org/fhir"> 
 <!-- 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>
 <version value="[string]"/><!-- 0..1 A business level identifier of the product -->
 <status><!-- 0..1 Coding The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization status --></status>
 <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 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 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 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..* Reference to another product, e.g. for linking authorised to investigational product -->
  <product[x]><!-- 1..1 Identifier|Reference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product --></product[x]>
  <type><!-- 0..1 Coding The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version --></type>
 </crossReference>
 <manufacturingBusinessOperation>  <!-- 0..* An operation applied to the product, for manufacturing or adminsitrative purpose -->
  <type[x]><!-- 0..1 Coding|Reference(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[x]>
  <effectiveDate><!-- 0..1 Period Date range of applicability --></effectiveDate>
  <manufacturer><!-- 0..* Reference(Organization) The manufacturer or establishment associated with the process --></manufacturer>
  <authorization><!-- 0..1 Reference(RegulatedAuthorization) An authorization for this process, either as a logical reference, holding just an identifier, or a full refererence to a resource that captures the details. The authorization mayu possibly apply to several products or a wider scope of process of which this is a part --></authorization>
  <confidentialityIndicator><!-- 0..1 CodeableConcept To indicate if this proces is commercially confidential --></confidentialityIndicator>
 </manufacturingBusinessOperation>
</MedicinalProductDefinition>

JSON Template

{
  "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
  "version" : "<string>", // A business level identifier of the product
  "status" : { Coding }, // The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization status
  "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>", // 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 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" : { 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" : [{ // Reference to another product, e.g. for linking authorised to investigational product
    // product[x]: Reference to another product, e.g. for linking authorised to investigational product. One of these 2:
    "productIdentifier" : { Identifier },
    "productReference" : { Reference(MedicinalProductDefinition) },
    "type" : { Coding } // The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version
  }],
  "manufacturingBusinessOperation" : [{ // An operation applied to the product, for manufacturing or adminsitrative purpose
    // type[x]: 
      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. One of these 2:
    "typeCoding" : { Coding },
    "typeReference" : { Reference(ActivityDefinition) },
    "effectiveDate" : { Period }, // Date range of applicability
    "manufacturer" : [{ Reference(Organization) }], // The manufacturer or establishment associated with the process
    "authorization" : { Reference(RegulatedAuthorization) }, // An authorization for this process, either as a logical reference, holding just an identifier, or a full refererence to a resource that captures the details. The authorization mayu possibly apply to several products or a wider scope of process of which this is a part
    "confidentialityIndicator" : { CodeableConcept } // To indicate if this proces is commercially confidential
  }]
}

Turtle Template

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


[ 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.version [ string ]; # 0..1 A business level identifier of the product
  fhir:MedicinalProductDefinition.status [ Coding ]; # 0..1 The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization status
  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 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 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 [ 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 [ # 0..* Reference to another product, e.g. for linking authorised to investigational product
    # MedicinalProductDefinition.crossReference.product[x] : 1..1 Reference to another product, e.g. for linking authorised to investigational product. One of these 2
      fhir:MedicinalProductDefinition.crossReference.productIdentifier [ Identifier ]
      fhir:MedicinalProductDefinition.crossReference.productReference [ Reference(MedicinalProductDefinition) ]
    fhir:MedicinalProductDefinition.crossReference.type [ Coding ]; # 0..1 The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version
  ], ...;
  fhir:MedicinalProductDefinition.manufacturingBusinessOperation [ # 0..* An operation applied to the product, for manufacturing or adminsitrative purpose
    # MedicinalProductDefinition.manufacturingBusinessOperation.type[x] : 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. One of these 2
      fhir:MedicinalProductDefinition.manufacturingBusinessOperation.typeCoding [ Coding ]
      fhir:MedicinalProductDefinition.manufacturingBusinessOperation.typeReference [ Reference(ActivityDefinition) ]
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.effectiveDate [ Period ]; # 0..1 Date range of applicability
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.manufacturer [ Reference(Organization) ], ... ; # 0..* The manufacturer or establishment associated with the process
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.authorization [ Reference(RegulatedAuthorization) ]; # 0..1 An authorization for this process, either as a logical reference, holding just an identifier, or a full refererence to a resource that captures the details. The authorization mayu possibly apply to several products or a wider scope of process of which this is a part
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.confidentialityIndicator [ CodeableConcept ]; # 0..1 To indicate if this proces is commercially confidential
  ], ...;
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Structure

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition	Σ TU		DomainResource	Detailed 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	Σ	0..*	Identifier	Business identifier for this product. Could be an MPID
type	Σ	0..1	CodeableConcept	Regulatory type, e.g. Investigational or Authorized
domain	Σ	0..1	Coding	If this medicine applies to human or veterinary uses
version	Σ	0..1	string	A business level identifier of the product
status	Σ	0..1	Coding	The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization status PublicationStatus (Preferred)
description	Σ	0..1	markdown	General description of this product
combinedPharmaceuticalDoseForm	Σ	0..1	CodeableConcept	The dose form for a single part product, or combined form of a multiple part product
indication	Σ	0..1	markdown	General combined description of indication(s) for this product. See also MedicinalProductDefinitionIndication
legalStatusOfSupply	Σ	0..1	CodeableConcept	The legal status of supply of the medicinal product as classified by the regulator
additionalMonitoringIndicator	Σ	0..1	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
specialMeasures	Σ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons
paediatricUseIndicator	Σ	0..1	CodeableConcept	If authorised for use in children
productClassification	Σ	0..*	CodeableConcept	Allows the product to be classified by various systems
marketingStatus	Σ	0..*	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorizaton
pharmaceuticalProduct	Σ	0..*	Reference(AdministrableProductDefinition)	Pharmaceutical aspects of product
packagedMedicinalProduct	Σ	0..*	Reference(PackagedProductDefinition)	Package representation for the product
ingredient	Σ	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
attachedDocument	Σ	0..*	Reference(DocumentReference)	Supporting documentation, typically for regulatory submission
masterFile	Σ	0..*	Reference(DocumentReference)	A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
contact	Σ	0..*	BackboneElement	A product specific contact, person (in a role), or an organization
type	Σ	0..1	CodeableConcept	Allows the contact to be classified, for example QPPV, Pharmacovigilence Enquiry Information
contact	Σ	1..1	Reference(Organization \| PractitionerRole)	A product specific contact, person (in a role), or an organization
clinicalTrial	Σ	0..*	Reference(ResearchStudy)	Clinical trials or studies that this product is involved in
name	Σ	1..*	BackboneElement	The product's name, including full name and possibly coded parts
productName	Σ	1..1	string	The full product name
type	Σ	0..1	Coding	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
namePart	Σ	0..*	BackboneElement	Coding words or phrases of the name
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	Coding	Idenifying type for this part of the name (e.g. strength part)
countryLanguage	Σ	0..*	BackboneElement	Country where the name applies
country	Σ	1..1	CodeableConcept	Country code for where this name applies
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction code for where this name applies
language	Σ	1..1	CodeableConcept	Language code for this name
crossReference	Σ	0..*	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
product[x]	Σ	1..1		Reference to another product, e.g. for linking authorised to investigational product
productIdentifier			Identifier
productReference			Reference(MedicinalProductDefinition)
type	Σ	0..1	Coding	The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version
manufacturingBusinessOperation	Σ	0..*	BackboneElement	An operation applied to the product, for manufacturing or adminsitrative purpose
type[x]	Σ	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
typeCoding			Coding
typeReference			Reference(ActivityDefinition)
effectiveDate	Σ	0..1	Period	Date range of applicability
manufacturer	Σ	0..*	Reference(Organization)	The manufacturer or establishment associated with the process
authorization	Σ	0..1	Reference(RegulatedAuthorization)	An authorization for this process, either as a logical reference, holding just an identifier, or a full refererence to a resource that captures the details. The authorization mayu possibly apply to several products or a wider scope of process of which this is a part
confidentialityIndicator	Σ	0..1	CodeableConcept	To indicate if this proces is commercially confidential
Documentation for this format

UML Diagram (Legend)

XML Template

<MedicinalProductDefinition xmlns="http://hl7.org/fhir"> 
 <!-- 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>
 <version value="[string]"/><!-- 0..1 A business level identifier of the product -->
 <status><!-- 0..1 Coding The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization status --></status>
 <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 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 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 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..* Reference to another product, e.g. for linking authorised to investigational product -->
  <product[x]><!-- 1..1 Identifier|Reference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product --></product[x]>
  <type><!-- 0..1 Coding The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version --></type>
 </crossReference>
 <manufacturingBusinessOperation>  <!-- 0..* An operation applied to the product, for manufacturing or adminsitrative purpose -->
  <type[x]><!-- 0..1 Coding|Reference(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[x]>
  <effectiveDate><!-- 0..1 Period Date range of applicability --></effectiveDate>
  <manufacturer><!-- 0..* Reference(Organization) The manufacturer or establishment associated with the process --></manufacturer>
  <authorization><!-- 0..1 Reference(RegulatedAuthorization) An authorization for this process, either as a logical reference, holding just an identifier, or a full refererence to a resource that captures the details. The authorization mayu possibly apply to several products or a wider scope of process of which this is a part --></authorization>
  <confidentialityIndicator><!-- 0..1 CodeableConcept To indicate if this proces is commercially confidential --></confidentialityIndicator>
 </manufacturingBusinessOperation>
</MedicinalProductDefinition>

JSON Template

{
  "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
  "version" : "<string>", // A business level identifier of the product
  "status" : { Coding }, // The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization status
  "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>", // 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 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" : { 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" : [{ // Reference to another product, e.g. for linking authorised to investigational product
    // product[x]: Reference to another product, e.g. for linking authorised to investigational product. One of these 2:
    "productIdentifier" : { Identifier },
    "productReference" : { Reference(MedicinalProductDefinition) },
    "type" : { Coding } // The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version
  }],
  "manufacturingBusinessOperation" : [{ // An operation applied to the product, for manufacturing or adminsitrative purpose
    // type[x]: 
      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. One of these 2:
    "typeCoding" : { Coding },
    "typeReference" : { Reference(ActivityDefinition) },
    "effectiveDate" : { Period }, // Date range of applicability
    "manufacturer" : [{ Reference(Organization) }], // The manufacturer or establishment associated with the process
    "authorization" : { Reference(RegulatedAuthorization) }, // An authorization for this process, either as a logical reference, holding just an identifier, or a full refererence to a resource that captures the details. The authorization mayu possibly apply to several products or a wider scope of process of which this is a part
    "confidentialityIndicator" : { CodeableConcept } // To indicate if this proces is commercially confidential
  }]
}

Turtle Template

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


[ 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.version [ string ]; # 0..1 A business level identifier of the product
  fhir:MedicinalProductDefinition.status [ Coding ]; # 0..1 The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization status
  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 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 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 [ 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 [ # 0..* Reference to another product, e.g. for linking authorised to investigational product
    # MedicinalProductDefinition.crossReference.product[x] : 1..1 Reference to another product, e.g. for linking authorised to investigational product. One of these 2
      fhir:MedicinalProductDefinition.crossReference.productIdentifier [ Identifier ]
      fhir:MedicinalProductDefinition.crossReference.productReference [ Reference(MedicinalProductDefinition) ]
    fhir:MedicinalProductDefinition.crossReference.type [ Coding ]; # 0..1 The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version
  ], ...;
  fhir:MedicinalProductDefinition.manufacturingBusinessOperation [ # 0..* An operation applied to the product, for manufacturing or adminsitrative purpose
    # MedicinalProductDefinition.manufacturingBusinessOperation.type[x] : 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. One of these 2
      fhir:MedicinalProductDefinition.manufacturingBusinessOperation.typeCoding [ Coding ]
      fhir:MedicinalProductDefinition.manufacturingBusinessOperation.typeReference [ Reference(ActivityDefinition) ]
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.effectiveDate [ Period ]; # 0..1 Date range of applicability
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.manufacturer [ Reference(Organization) ], ... ; # 0..* The manufacturer or establishment associated with the process
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.authorization [ Reference(RegulatedAuthorization) ]; # 0..1 An authorization for this process, either as a logical reference, holding just an identifier, or a full refererence to a resource that captures the details. The authorization mayu possibly apply to several products or a wider scope of process of which this is a part
    fhir:MedicinalProductDefinition.manufacturingBusinessOperation.confidentialityIndicator [ CodeableConcept ]; # 0..1 To indicate if this proces is commercially confidential
  ], ...;
]

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

11.11.3.1 Terminology Bindings

Path	Definition	Type	Reference
MedicinalProductDefinition.status	Identifies the level of importance to be assigned to actioning the request.	Preferred	PublicationStatus

Path

Definition

Type

Reference

MedicinalProductDefinition.status

Identifies the level of importance to be assigned to actioning the request.

Preferred

PublicationStatus

11.11.4 Search Parameters

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

Name	Type	Description	Expression	In Common
contact	reference	A product specific contact, person (in a role), or an organization	MedicinalProductDefinition.contact.contact (Organization, PractitionerRole)
identifier	token	Business identifier for this product. Could be an MPID	MedicinalProductDefinition.identifier
master-file	reference	A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)	MedicinalProductDefinition.masterFile (DocumentReference)
name N	string	The full product name	MedicinalProductDefinition.name.productName
name-language	token	Language code for this name	MedicinalProductDefinition.name.countryLanguage.language
product-classification	token	Allows the product to be classified by various systems	MedicinalProductDefinition.productClassification