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15.1 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, drug catalogs).

15.1.1 Scope and Usage

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

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

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

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

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

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

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

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

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

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

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

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

15.1.2 References

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

This resource does not implement any patterns.

Structure

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition	TU		DomainResource	Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use, drug catalogs) Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	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	CodeableConcept	If this medicine applies to human or veterinary uses
version	Σ	0..1	string	A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product
status	Σ	0..1	CodeableConcept	The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status PublicationStatus (Preferred)
statusDate	Σ	0..1	dateTime	The date at which the given status became applicable
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	Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseIssue resource. An indication is a medical situation for which using the product is appropriate
legalStatusOfSupply	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
classification	Σ	0..*	CodeableConcept	Allows the product to be classified by various systems
characteristic	Σ	0..*	CodeableConcept	Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"
marketingStatus	Σ	0..*	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorization
ingredient	Σ	0..*	CodeableReference(Ingredient)	The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly here
impurity	Σ	0..*	Reference(SubstanceDefinition)	Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional information or supporting documentation about the medicinal product
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, Pharmacovigilance 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	CodeableConcept	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	CodeableConcept	Identifying 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	Σ	1..1	CodeableReference(MedicinalProductDefinition)	Reference to another product, e.g. for linking authorised to investigational product
type	Σ	0..1	CodeableConcept	The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version
operation	Σ	0..*	BackboneElement	A manufacturing or administrative process or step associated with (or performed on) the medicinal product
type	Σ	0..1	CodeableReference(ActivityDefinition)	The type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute
effectiveDate	Σ	0..1	Period	Date range of applicability
organization	Σ	0..*	Reference(Organization)	The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent
authorization	Σ	0..1	Reference(RegulatedAuthorization)	An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a part
confidentialityIndicator	Σ	0..1	CodeableConcept	Specifies whether this particular business or manufacturing process is considered proprietary or confidential
package		0..*	BackboneElement	Package representation for the product
type		0..1	CodeableConcept	A descriptive type for this package, such as box, carton or bottle
size[x]		0..1		The amount of items, or of substance, in the package
sizeQuantity			Quantity
sizeInteger			integer
package		0..1	Reference(PackagedProductDefinition)	Full package representation for the product
administrableProduct	Σ	0..*	BackboneElement	The product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable item
route	Σ	0..*	CodeableConcept	The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route
product	Σ	0..1	Reference(AdministrableProductDefinition)	Full description of the administrable product
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 CodeableConcept If this medicine applies to human or veterinary uses --></domain>
 <version value="[string]"/><!-- 0..1 A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product -->
 <status><!-- 0..1 CodeableConcept The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status --></status>
 <statusDate value="[dateTime]"/><!-- 0..1 The date at which the given status became applicable -->
 <description value="[markdown]"/><!-- 0..1 General description of this product -->
 <combinedPharmaceuticalDoseForm><!-- 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product --></combinedPharmaceuticalDoseForm>
 <indication value="[markdown]"/><!-- 0..1 Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseIssue resource. An indication is a medical situation for which using the product is appropriate -->
 <legalStatusOfSupply><!-- 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator --></legalStatusOfSupply>
 <additionalMonitoringIndicator><!-- 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons --></additionalMonitoringIndicator>
 <specialMeasures><!-- 0..* CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons --></specialMeasures>
 <paediatricUseIndicator><!-- 0..1 CodeableConcept If authorised for use in children --></paediatricUseIndicator>
 <classification><!-- 0..* CodeableConcept Allows the product to be classified by various systems --></classification>
 <characteristic><!-- 0..* CodeableConcept Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import" --></characteristic>
 <marketingStatus><!-- 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization --></marketingStatus>
 <ingredient><!-- 0..* CodeableReference(Ingredient) The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly here --></ingredient>
 <impurity><!-- 0..* Reference(SubstanceDefinition) Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products --></impurity>
 <attachedDocument><!-- 0..* Reference(DocumentReference) Additional information or supporting documentation about the medicinal product --></attachedDocument>
 <masterFile><!-- 0..* Reference(DocumentReference) A master file for to the medicinal product (e.g. Pharmacovigilance System Master File) --></masterFile>
 <contact>  <!-- 0..* A product specific contact, person (in a role), or an organization -->
  <type><!-- 0..1 CodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information --></type>
  <contact><!-- 1..1 Reference(Organization|PractitionerRole) A product specific contact, person (in a role), or an organization --></contact>
 </contact>
 <clinicalTrial><!-- 0..* Reference(ResearchStudy) Clinical trials or studies that this product is involved in --></clinicalTrial>
 <name>  <!-- 1..* The product's name, including full name and possibly coded parts -->
  <productName value="[string]"/><!-- 1..1 The full product name -->
  <type><!-- 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary --></type>
  <namePart>  <!-- 0..* Coding words or phrases of the name -->
   <part value="[string]"/><!-- 1..1 A fragment of a product name -->
   <type><!-- 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part) --></type>
  </namePart>
  <countryLanguage>  <!-- 0..* Country where the name applies -->
   <country><!-- 1..1 CodeableConcept Country code for where this name applies --></country>
   <jurisdiction><!-- 0..1 CodeableConcept Jurisdiction code for where this name applies --></jurisdiction>
   <language><!-- 1..1 CodeableConcept Language code for this name --></language>
  </countryLanguage>
 </name>
 <crossReference>  <!-- 0..* Reference to another product, e.g. for linking authorised to investigational product -->
  <product><!-- 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product --></product>
  <type><!-- 0..1 CodeableConcept The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version --></type>
 </crossReference>
 <operation>  <!-- 0..* A manufacturing or administrative process or step associated with (or performed on) the medicinal product -->
  <type><!-- 0..1 CodeableReference(ActivityDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute --></type>
  <effectiveDate><!-- 0..1 Period Date range of applicability --></effectiveDate>
  <organization><!-- 0..* Reference(Organization) The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent --></organization>
  <authorization><!-- 0..1 Reference(RegulatedAuthorization) An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a part --></authorization>
  <confidentialityIndicator><!-- 0..1 CodeableConcept Specifies whether this particular business or manufacturing process is considered proprietary or confidential --></confidentialityIndicator>
 </operation>
 <package>  <!-- 0..* Package representation for the product -->
  <type><!-- 0..1 CodeableConcept A descriptive type for this package, such as box, carton or bottle --></type>
  <size[x]><!-- 0..1 Quantity|integer The amount of items, or of substance, in the package --></size[x]>
  <package><!-- 0..1 Reference(PackagedProductDefinition) Full package representation for the product --></package>
 </package>
 <administrableProduct>  <!-- 0..* The product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable item -->
  <route><!-- 0..* CodeableConcept The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route --></route>
  <product><!-- 0..1 Reference(AdministrableProductDefinition) Full description of the administrable product --></product>
 </administrableProduct>
</MedicinalProductDefinition>

JSON Template

{
  "resourceType" : "MedicinalProductDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business identifier for this product. Could be an MPID
  "type" : { CodeableConcept }, // Regulatory type, e.g. Investigational or Authorized
  "domain" : { CodeableConcept }, // If this medicine applies to human or veterinary uses
  "version" : "<string>", // A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product
  "status" : { CodeableConcept }, // The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status
  "statusDate" : "<dateTime>", // The date at which the given status became applicable
  "description" : "<markdown>", // General description of this product
  "combinedPharmaceuticalDoseForm" : { CodeableConcept }, // The dose form for a single part product, or combined form of a multiple part product
  "indication" : "<markdown>", // Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseIssue resource. An indication is a medical situation for which using the product is appropriate
  "legalStatusOfSupply" : { CodeableConcept }, // The legal status of supply of the medicinal product as classified by the regulator
  "additionalMonitoringIndicator" : { CodeableConcept }, // Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
  "specialMeasures" : [{ CodeableConcept }], // Whether the Medicinal Product is subject to special measures for regulatory reasons
  "paediatricUseIndicator" : { CodeableConcept }, // If authorised for use in children
  "classification" : [{ CodeableConcept }], // Allows the product to be classified by various systems
  "characteristic" : [{ CodeableConcept }], // Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"
  "marketingStatus" : [{ MarketingStatus }], // Marketing status of the medicinal product, in contrast to marketing authorization
  "ingredient" : [{ CodeableReference(Ingredient) }], // The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly here
  "impurity" : [{ Reference(SubstanceDefinition) }], // Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products
  "attachedDocument" : [{ Reference(DocumentReference) }], // Additional information or supporting documentation about the medicinal product
  "masterFile" : [{ Reference(DocumentReference) }], // A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
  "contact" : [{ // A product specific contact, person (in a role), or an organization
    "type" : { CodeableConcept }, // Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
    "contact" : { Reference(Organization|PractitionerRole) } // R!  A product specific contact, person (in a role), or an organization
  }],
  "clinicalTrial" : [{ Reference(ResearchStudy) }], // Clinical trials or studies that this product is involved in
  "name" : [{ // R!  The product's name, including full name and possibly coded parts
    "productName" : "<string>", // R!  The full product name
    "type" : { CodeableConcept }, // Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
    "namePart" : [{ // Coding words or phrases of the name
      "part" : "<string>", // R!  A fragment of a product name
      "type" : { CodeableConcept } // R!  Identifying type for this part of the name (e.g. strength part)
    }],
    "countryLanguage" : [{ // Country where the name applies
      "country" : { CodeableConcept }, // R!  Country code for where this name applies
      "jurisdiction" : { CodeableConcept }, // Jurisdiction code for where this name applies
      "language" : { CodeableConcept } // R!  Language code for this name
    }]
  }],
  "crossReference" : [{ // Reference to another product, e.g. for linking authorised to investigational product
    "product" : { CodeableReference(MedicinalProductDefinition) }, // R!  Reference to another product, e.g. for linking authorised to investigational product
    "type" : { CodeableConcept } // The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version
  }],
  "operation" : [{ // A manufacturing or administrative process or step associated with (or performed on) the medicinal product
    "type" : { CodeableReference(ActivityDefinition) }, // The type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute
    "effectiveDate" : { Period }, // Date range of applicability
    "organization" : [{ Reference(Organization) }], // The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent
    "authorization" : { Reference(RegulatedAuthorization) }, // An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a part
    "confidentialityIndicator" : { CodeableConcept } // Specifies whether this particular business or manufacturing process is considered proprietary or confidential
  }],
  "package" : [{ // Package representation for the product
    "type" : { CodeableConcept }, // A descriptive type for this package, such as box, carton or bottle
    // size[x]: The amount of items, or of substance, in the package. One of these 2:
    "sizeQuantity" : { Quantity },
    "sizeInteger" : <integer>,
    "package" : { Reference(PackagedProductDefinition) } // Full package representation for the product
  }],
  "administrableProduct" : [{ // The product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable item
    "route" : [{ CodeableConcept }], // The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route
    "product" : { Reference(AdministrableProductDefinition) } // Full description of the administrable product
  }]
}

Turtle Template

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


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

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:MedicinalProductDefinition.identifier [ Identifier ], ... ; # 0..* Business identifier for this product. Could be an MPID
  fhir:MedicinalProductDefinition.type [ CodeableConcept ]; # 0..1 Regulatory type, e.g. Investigational or Authorized
  fhir:MedicinalProductDefinition.domain [ CodeableConcept ]; # 0..1 If this medicine applies to human or veterinary uses
  fhir:MedicinalProductDefinition.version [ string ]; # 0..1 A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product
  fhir:MedicinalProductDefinition.status [ CodeableConcept ]; # 0..1 The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status
  fhir:MedicinalProductDefinition.statusDate [ dateTime ]; # 0..1 The date at which the given status became applicable
  fhir:MedicinalProductDefinition.description [ markdown ]; # 0..1 General description of this product
  fhir:MedicinalProductDefinition.combinedPharmaceuticalDoseForm [ CodeableConcept ]; # 0..1 The dose form for a single part product, or combined form of a multiple part product
  fhir:MedicinalProductDefinition.indication [ markdown ]; # 0..1 Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseIssue resource. An indication is a medical situation for which using the product is appropriate
  fhir:MedicinalProductDefinition.legalStatusOfSupply [ CodeableConcept ]; # 0..1 The legal status of supply of the medicinal product as classified by the regulator
  fhir:MedicinalProductDefinition.additionalMonitoringIndicator [ CodeableConcept ]; # 0..1 Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
  fhir:MedicinalProductDefinition.specialMeasures [ CodeableConcept ], ... ; # 0..* Whether the Medicinal Product is subject to special measures for regulatory reasons
  fhir:MedicinalProductDefinition.paediatricUseIndicator [ CodeableConcept ]; # 0..1 If authorised for use in children
  fhir:MedicinalProductDefinition.classification [ CodeableConcept ], ... ; # 0..* Allows the product to be classified by various systems
  fhir:MedicinalProductDefinition.characteristic [ CodeableConcept ], ... ; # 0..* Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"
  fhir:MedicinalProductDefinition.marketingStatus [ MarketingStatus ], ... ; # 0..* Marketing status of the medicinal product, in contrast to marketing authorization
  fhir:MedicinalProductDefinition.ingredient [ CodeableReference(Ingredient) ], ... ; # 0..* The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly here
  fhir:MedicinalProductDefinition.impurity [ Reference(SubstanceDefinition) ], ... ; # 0..* Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products
  fhir:MedicinalProductDefinition.attachedDocument [ Reference(DocumentReference) ], ... ; # 0..* Additional information or supporting documentation about the medicinal product
  fhir:MedicinalProductDefinition.masterFile [ Reference(DocumentReference) ], ... ; # 0..* A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
  fhir:MedicinalProductDefinition.contact [ # 0..* A product specific contact, person (in a role), or an organization
    fhir:MedicinalProductDefinition.contact.type [ CodeableConcept ]; # 0..1 Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
    fhir:MedicinalProductDefinition.contact.contact [ Reference(Organization|PractitionerRole) ]; # 1..1 A product specific contact, person (in a role), or an organization
  ], ...;
  fhir:MedicinalProductDefinition.clinicalTrial [ Reference(ResearchStudy) ], ... ; # 0..* Clinical trials or studies that this product is involved in
  fhir:MedicinalProductDefinition.name [ # 1..* The product's name, including full name and possibly coded parts
    fhir:MedicinalProductDefinition.name.productName [ string ]; # 1..1 The full product name
    fhir:MedicinalProductDefinition.name.type [ CodeableConcept ]; # 0..1 Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
    fhir:MedicinalProductDefinition.name.namePart [ # 0..* Coding words or phrases of the name
      fhir:MedicinalProductDefinition.name.namePart.part [ string ]; # 1..1 A fragment of a product name
      fhir:MedicinalProductDefinition.name.namePart.type [ CodeableConcept ]; # 1..1 Identifying type for this part of the name (e.g. strength part)
    ], ...;
    fhir:MedicinalProductDefinition.name.countryLanguage [ # 0..* Country where the name applies
      fhir:MedicinalProductDefinition.name.countryLanguage.country [ CodeableConcept ]; # 1..1 Country code for where this name applies
      fhir:MedicinalProductDefinition.name.countryLanguage.jurisdiction [ CodeableConcept ]; # 0..1 Jurisdiction code for where this name applies
      fhir:MedicinalProductDefinition.name.countryLanguage.language [ CodeableConcept ]; # 1..1 Language code for this name
    ], ...;
  ], ...;
  fhir:MedicinalProductDefinition.crossReference [ # 0..* Reference to another product, e.g. for linking authorised to investigational product
    fhir:MedicinalProductDefinition.crossReference.product [ CodeableReference(MedicinalProductDefinition) ]; # 1..1 Reference to another product, e.g. for linking authorised to investigational product
    fhir:MedicinalProductDefinition.crossReference.type [ CodeableConcept ]; # 0..1 The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version
  ], ...;
  fhir:MedicinalProductDefinition.operation [ # 0..* A manufacturing or administrative process or step associated with (or performed on) the medicinal product
    fhir:MedicinalProductDefinition.operation.type [ CodeableReference(ActivityDefinition) ]; # 0..1 The type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute
    fhir:MedicinalProductDefinition.operation.effectiveDate [ Period ]; # 0..1 Date range of applicability
    fhir:MedicinalProductDefinition.operation.organization [ Reference(Organization) ], ... ; # 0..* The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent
    fhir:MedicinalProductDefinition.operation.authorization [ Reference(RegulatedAuthorization) ]; # 0..1 An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a part
    fhir:MedicinalProductDefinition.operation.confidentialityIndicator [ CodeableConcept ]; # 0..1 Specifies whether this particular business or manufacturing process is considered proprietary or confidential
  ], ...;
  fhir:MedicinalProductDefinition.package [ # 0..* Package representation for the product
    fhir:MedicinalProductDefinition.package.type [ CodeableConcept ]; # 0..1 A descriptive type for this package, such as box, carton or bottle
    # MedicinalProductDefinition.package.size[x] : 0..1 The amount of items, or of substance, in the package. One of these 2
      fhir:MedicinalProductDefinition.package.sizeQuantity [ Quantity ]
      fhir:MedicinalProductDefinition.package.sizeInteger [ integer ]
    fhir:MedicinalProductDefinition.package.package [ Reference(PackagedProductDefinition) ]; # 0..1 Full package representation for the product
  ], ...;
  fhir:MedicinalProductDefinition.administrableProduct [ # 0..* The product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable item
    fhir:MedicinalProductDefinition.administrableProduct.route [ CodeableConcept ], ... ; # 0..* The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route
    fhir:MedicinalProductDefinition.administrableProduct.product [ Reference(AdministrableProductDefinition) ]; # 0..1 Full description of the administrable product
  ], ...;
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Structure

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition	TU		DomainResource	Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use, drug catalogs) Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	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	CodeableConcept	If this medicine applies to human or veterinary uses
version	Σ	0..1	string	A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product
status	Σ	0..1	CodeableConcept	The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status PublicationStatus (Preferred)
statusDate	Σ	0..1	dateTime	The date at which the given status became applicable
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	Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseIssue resource. An indication is a medical situation for which using the product is appropriate
legalStatusOfSupply	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
classification	Σ	0..*	CodeableConcept	Allows the product to be classified by various systems
characteristic	Σ	0..*	CodeableConcept	Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"
marketingStatus	Σ	0..*	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorization
ingredient	Σ	0..*	CodeableReference(Ingredient)	The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly here
impurity	Σ	0..*	Reference(SubstanceDefinition)	Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional information or supporting documentation about the medicinal product
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, Pharmacovigilance 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	CodeableConcept	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	CodeableConcept	Identifying 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	Σ	1..1	CodeableReference(MedicinalProductDefinition)	Reference to another product, e.g. for linking authorised to investigational product
type	Σ	0..1	CodeableConcept	The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version
operation	Σ	0..*	BackboneElement	A manufacturing or administrative process or step associated with (or performed on) the medicinal product
type	Σ	0..1	CodeableReference(ActivityDefinition)	The type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute
effectiveDate	Σ	0..1	Period	Date range of applicability
organization	Σ	0..*	Reference(Organization)	The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent
authorization	Σ	0..1	Reference(RegulatedAuthorization)	An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a part
confidentialityIndicator	Σ	0..1	CodeableConcept	Specifies whether this particular business or manufacturing process is considered proprietary or confidential
package		0..*	BackboneElement	Package representation for the product
type		0..1	CodeableConcept	A descriptive type for this package, such as box, carton or bottle
size[x]		0..1		The amount of items, or of substance, in the package
sizeQuantity			Quantity
sizeInteger			integer
package		0..1	Reference(PackagedProductDefinition)	Full package representation for the product
administrableProduct	Σ	0..*	BackboneElement	The product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable item
route	Σ	0..*	CodeableConcept	The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route
product	Σ	0..1	Reference(AdministrableProductDefinition)	Full description of the administrable product
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 CodeableConcept If this medicine applies to human or veterinary uses --></domain>
 <version value="[string]"/><!-- 0..1 A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product -->
 <status><!-- 0..1 CodeableConcept The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status --></status>
 <statusDate value="[dateTime]"/><!-- 0..1 The date at which the given status became applicable -->
 <description value="[markdown]"/><!-- 0..1 General description of this product -->
 <combinedPharmaceuticalDoseForm><!-- 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product --></combinedPharmaceuticalDoseForm>
 <indication value="[markdown]"/><!-- 0..1 Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseIssue resource. An indication is a medical situation for which using the product is appropriate -->
 <legalStatusOfSupply><!-- 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator --></legalStatusOfSupply>
 <additionalMonitoringIndicator><!-- 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons --></additionalMonitoringIndicator>
 <specialMeasures><!-- 0..* CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons --></specialMeasures>
 <paediatricUseIndicator><!-- 0..1 CodeableConcept If authorised for use in children --></paediatricUseIndicator>
 <classification><!-- 0..* CodeableConcept Allows the product to be classified by various systems --></classification>
 <characteristic><!-- 0..* CodeableConcept Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import" --></characteristic>
 <marketingStatus><!-- 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization --></marketingStatus>
 <ingredient><!-- 0..* CodeableReference(Ingredient) The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly here --></ingredient>
 <impurity><!-- 0..* Reference(SubstanceDefinition) Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products --></impurity>
 <attachedDocument><!-- 0..* Reference(DocumentReference) Additional information or supporting documentation about the medicinal product --></attachedDocument>
 <masterFile><!-- 0..* Reference(DocumentReference) A master file for to the medicinal product (e.g. Pharmacovigilance System Master File) --></masterFile>
 <contact>  <!-- 0..* A product specific contact, person (in a role), or an organization -->
  <type><!-- 0..1 CodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information --></type>
  <contact><!-- 1..1 Reference(Organization|PractitionerRole) A product specific contact, person (in a role), or an organization --></contact>
 </contact>
 <clinicalTrial><!-- 0..* Reference(ResearchStudy) Clinical trials or studies that this product is involved in --></clinicalTrial>
 <name>  <!-- 1..* The product's name, including full name and possibly coded parts -->
  <productName value="[string]"/><!-- 1..1 The full product name -->
  <type><!-- 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary --></type>
  <namePart>  <!-- 0..* Coding words or phrases of the name -->
   <part value="[string]"/><!-- 1..1 A fragment of a product name -->
   <type><!-- 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part) --></type>
  </namePart>
  <countryLanguage>  <!-- 0..* Country where the name applies -->
   <country><!-- 1..1 CodeableConcept Country code for where this name applies --></country>
   <jurisdiction><!-- 0..1 CodeableConcept Jurisdiction code for where this name applies --></jurisdiction>
   <language><!-- 1..1 CodeableConcept Language code for this name --></language>
  </countryLanguage>
 </name>
 <crossReference>  <!-- 0..* Reference to another product, e.g. for linking authorised to investigational product -->
  <product><!-- 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product --></product>
  <type><!-- 0..1 CodeableConcept The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version --></type>
 </crossReference>
 <operation>  <!-- 0..* A manufacturing or administrative process or step associated with (or performed on) the medicinal product -->
  <type><!-- 0..1 CodeableReference(ActivityDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute --></type>
  <effectiveDate><!-- 0..1 Period Date range of applicability --></effectiveDate>
  <organization><!-- 0..* Reference(Organization) The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent --></organization>
  <authorization><!-- 0..1 Reference(RegulatedAuthorization) An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a part --></authorization>
  <confidentialityIndicator><!-- 0..1 CodeableConcept Specifies whether this particular business or manufacturing process is considered proprietary or confidential --></confidentialityIndicator>
 </operation>
 <package>  <!-- 0..* Package representation for the product -->
  <type><!-- 0..1 CodeableConcept A descriptive type for this package, such as box, carton or bottle --></type>
  <size[x]><!-- 0..1 Quantity|integer The amount of items, or of substance, in the package --></size[x]>
  <package><!-- 0..1 Reference(PackagedProductDefinition) Full package representation for the product --></package>
 </package>
 <administrableProduct>  <!-- 0..* The product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable item -->
  <route><!-- 0..* CodeableConcept The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route --></route>
  <product><!-- 0..1 Reference(AdministrableProductDefinition) Full description of the administrable product --></product>
 </administrableProduct>
</MedicinalProductDefinition>

JSON Template

{
  "resourceType" : "MedicinalProductDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business identifier for this product. Could be an MPID
  "type" : { CodeableConcept }, // Regulatory type, e.g. Investigational or Authorized
  "domain" : { CodeableConcept }, // If this medicine applies to human or veterinary uses
  "version" : "<string>", // A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product
  "status" : { CodeableConcept }, // The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status
  "statusDate" : "<dateTime>", // The date at which the given status became applicable
  "description" : "<markdown>", // General description of this product
  "combinedPharmaceuticalDoseForm" : { CodeableConcept }, // The dose form for a single part product, or combined form of a multiple part product
  "indication" : "<markdown>", // Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseIssue resource. An indication is a medical situation for which using the product is appropriate
  "legalStatusOfSupply" : { CodeableConcept }, // The legal status of supply of the medicinal product as classified by the regulator
  "additionalMonitoringIndicator" : { CodeableConcept }, // Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
  "specialMeasures" : [{ CodeableConcept }], // Whether the Medicinal Product is subject to special measures for regulatory reasons
  "paediatricUseIndicator" : { CodeableConcept }, // If authorised for use in children
  "classification" : [{ CodeableConcept }], // Allows the product to be classified by various systems
  "characteristic" : [{ CodeableConcept }], // Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"
  "marketingStatus" : [{ MarketingStatus }], // Marketing status of the medicinal product, in contrast to marketing authorization
  "ingredient" : [{ CodeableReference(Ingredient) }], // The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly here
  "impurity" : [{ Reference(SubstanceDefinition) }], // Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products
  "attachedDocument" : [{ Reference(DocumentReference) }], // Additional information or supporting documentation about the medicinal product
  "masterFile" : [{ Reference(DocumentReference) }], // A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
  "contact" : [{ // A product specific contact, person (in a role), or an organization
    "type" : { CodeableConcept }, // Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
    "contact" : { Reference(Organization|PractitionerRole) } // R!  A product specific contact, person (in a role), or an organization
  }],
  "clinicalTrial" : [{ Reference(ResearchStudy) }], // Clinical trials or studies that this product is involved in
  "name" : [{ // R!  The product's name, including full name and possibly coded parts
    "productName" : "<string>", // R!  The full product name
    "type" : { CodeableConcept }, // Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
    "namePart" : [{ // Coding words or phrases of the name
      "part" : "<string>", // R!  A fragment of a product name
      "type" : { CodeableConcept } // R!  Identifying type for this part of the name (e.g. strength part)
    }],
    "countryLanguage" : [{ // Country where the name applies
      "country" : { CodeableConcept }, // R!  Country code for where this name applies
      "jurisdiction" : { CodeableConcept }, // Jurisdiction code for where this name applies
      "language" : { CodeableConcept } // R!  Language code for this name
    }]
  }],
  "crossReference" : [{ // Reference to another product, e.g. for linking authorised to investigational product
    "product" : { CodeableReference(MedicinalProductDefinition) }, // R!  Reference to another product, e.g. for linking authorised to investigational product
    "type" : { CodeableConcept } // The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version
  }],
  "operation" : [{ // A manufacturing or administrative process or step associated with (or performed on) the medicinal product
    "type" : { CodeableReference(ActivityDefinition) }, // The type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute
    "effectiveDate" : { Period }, // Date range of applicability
    "organization" : [{ Reference(Organization) }], // The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent
    "authorization" : { Reference(RegulatedAuthorization) }, // An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a part
    "confidentialityIndicator" : { CodeableConcept } // Specifies whether this particular business or manufacturing process is considered proprietary or confidential
  }],
  "package" : [{ // Package representation for the product
    "type" : { CodeableConcept }, // A descriptive type for this package, such as box, carton or bottle
    // size[x]: The amount of items, or of substance, in the package. One of these 2:
    "sizeQuantity" : { Quantity },
    "sizeInteger" : <integer>,
    "package" : { Reference(PackagedProductDefinition) } // Full package representation for the product
  }],
  "administrableProduct" : [{ // The product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable item
    "route" : [{ CodeableConcept }], // The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route
    "product" : { Reference(AdministrableProductDefinition) } // Full description of the administrable product
  }]
}

Turtle Template

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


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

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:MedicinalProductDefinition.identifier [ Identifier ], ... ; # 0..* Business identifier for this product. Could be an MPID
  fhir:MedicinalProductDefinition.type [ CodeableConcept ]; # 0..1 Regulatory type, e.g. Investigational or Authorized
  fhir:MedicinalProductDefinition.domain [ CodeableConcept ]; # 0..1 If this medicine applies to human or veterinary uses
  fhir:MedicinalProductDefinition.version [ string ]; # 0..1 A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product
  fhir:MedicinalProductDefinition.status [ CodeableConcept ]; # 0..1 The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status
  fhir:MedicinalProductDefinition.statusDate [ dateTime ]; # 0..1 The date at which the given status became applicable
  fhir:MedicinalProductDefinition.description [ markdown ]; # 0..1 General description of this product
  fhir:MedicinalProductDefinition.combinedPharmaceuticalDoseForm [ CodeableConcept ]; # 0..1 The dose form for a single part product, or combined form of a multiple part product
  fhir:MedicinalProductDefinition.indication [ markdown ]; # 0..1 Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseIssue resource. An indication is a medical situation for which using the product is appropriate
  fhir:MedicinalProductDefinition.legalStatusOfSupply [ CodeableConcept ]; # 0..1 The legal status of supply of the medicinal product as classified by the regulator
  fhir:MedicinalProductDefinition.additionalMonitoringIndicator [ CodeableConcept ]; # 0..1 Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
  fhir:MedicinalProductDefinition.specialMeasures [ CodeableConcept ], ... ; # 0..* Whether the Medicinal Product is subject to special measures for regulatory reasons
  fhir:MedicinalProductDefinition.paediatricUseIndicator [ CodeableConcept ]; # 0..1 If authorised for use in children
  fhir:MedicinalProductDefinition.classification [ CodeableConcept ], ... ; # 0..* Allows the product to be classified by various systems
  fhir:MedicinalProductDefinition.characteristic [ CodeableConcept ], ... ; # 0..* Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"
  fhir:MedicinalProductDefinition.marketingStatus [ MarketingStatus ], ... ; # 0..* Marketing status of the medicinal product, in contrast to marketing authorization
  fhir:MedicinalProductDefinition.ingredient [ CodeableReference(Ingredient) ], ... ; # 0..* The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly here
  fhir:MedicinalProductDefinition.impurity [ Reference(SubstanceDefinition) ], ... ; # 0..* Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products
  fhir:MedicinalProductDefinition.attachedDocument [ Reference(DocumentReference) ], ... ; # 0..* Additional information or supporting documentation about the medicinal product
  fhir:MedicinalProductDefinition.masterFile [ Reference(DocumentReference) ], ... ; # 0..* A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
  fhir:MedicinalProductDefinition.contact [ # 0..* A product specific contact, person (in a role), or an organization
    fhir:MedicinalProductDefinition.contact.type [ CodeableConcept ]; # 0..1 Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
    fhir:MedicinalProductDefinition.contact.contact [ Reference(Organization|PractitionerRole) ]; # 1..1 A product specific contact, person (in a role), or an organization
  ], ...;
  fhir:MedicinalProductDefinition.clinicalTrial [ Reference(ResearchStudy) ], ... ; # 0..* Clinical trials or studies that this product is involved in
  fhir:MedicinalProductDefinition.name [ # 1..* The product's name, including full name and possibly coded parts
    fhir:MedicinalProductDefinition.name.productName [ string ]; # 1..1 The full product name
    fhir:MedicinalProductDefinition.name.type [ CodeableConcept ]; # 0..1 Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
    fhir:MedicinalProductDefinition.name.namePart [ # 0..* Coding words or phrases of the name
      fhir:MedicinalProductDefinition.name.namePart.part [ string ]; # 1..1 A fragment of a product name
      fhir:MedicinalProductDefinition.name.namePart.type [ CodeableConcept ]; # 1..1 Identifying type for this part of the name (e.g. strength part)
    ], ...;
    fhir:MedicinalProductDefinition.name.countryLanguage [ # 0..* Country where the name applies
      fhir:MedicinalProductDefinition.name.countryLanguage.country [ CodeableConcept ]; # 1..1 Country code for where this name applies
      fhir:MedicinalProductDefinition.name.countryLanguage.jurisdiction [ CodeableConcept ]; # 0..1 Jurisdiction code for where this name applies
      fhir:MedicinalProductDefinition.name.countryLanguage.language [ CodeableConcept ]; # 1..1 Language code for this name
    ], ...;
  ], ...;
  fhir:MedicinalProductDefinition.crossReference [ # 0..* Reference to another product, e.g. for linking authorised to investigational product
    fhir:MedicinalProductDefinition.crossReference.product [ CodeableReference(MedicinalProductDefinition) ]; # 1..1 Reference to another product, e.g. for linking authorised to investigational product
    fhir:MedicinalProductDefinition.crossReference.type [ CodeableConcept ]; # 0..1 The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version
  ], ...;
  fhir:MedicinalProductDefinition.operation [ # 0..* A manufacturing or administrative process or step associated with (or performed on) the medicinal product
    fhir:MedicinalProductDefinition.operation.type [ CodeableReference(ActivityDefinition) ]; # 0..1 The type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute
    fhir:MedicinalProductDefinition.operation.effectiveDate [ Period ]; # 0..1 Date range of applicability
    fhir:MedicinalProductDefinition.operation.organization [ Reference(Organization) ], ... ; # 0..* The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent
    fhir:MedicinalProductDefinition.operation.authorization [ Reference(RegulatedAuthorization) ]; # 0..1 An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a part
    fhir:MedicinalProductDefinition.operation.confidentialityIndicator [ CodeableConcept ]; # 0..1 Specifies whether this particular business or manufacturing process is considered proprietary or confidential
  ], ...;
  fhir:MedicinalProductDefinition.package [ # 0..* Package representation for the product
    fhir:MedicinalProductDefinition.package.type [ CodeableConcept ]; # 0..1 A descriptive type for this package, such as box, carton or bottle
    # MedicinalProductDefinition.package.size[x] : 0..1 The amount of items, or of substance, in the package. One of these 2
      fhir:MedicinalProductDefinition.package.sizeQuantity [ Quantity ]
      fhir:MedicinalProductDefinition.package.sizeInteger [ integer ]
    fhir:MedicinalProductDefinition.package.package [ Reference(PackagedProductDefinition) ]; # 0..1 Full package representation for the product
  ], ...;
  fhir:MedicinalProductDefinition.administrableProduct [ # 0..* The product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable item
    fhir:MedicinalProductDefinition.administrableProduct.route [ CodeableConcept ], ... ; # 0..* The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route
    fhir:MedicinalProductDefinition.administrableProduct.product [ Reference(AdministrableProductDefinition) ]; # 0..1 Full description of the administrable product
  ], ...;
]

Changes since Release 3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

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

15.1.3.1 Terminology Bindings

Path	Definition	Type	Reference
MedicinalProductDefinition.status		Preferred	PublicationStatus

Path

Definition

Type

Reference

MedicinalProductDefinition.status

Preferred

PublicationStatus

15.1.4 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
characteristic	token	Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"	MedicinalProductDefinition.characteristic
contact	reference	A product specific contact, person (in a role), or an organization	MedicinalProductDefinition.contact.contact (Organization, PractitionerRole)
domain	token	If this medicine applies to human or veterinary uses	MedicinalProductDefinition.domain
identifier	token	Business identifier for this product. Could be an MPID	MedicinalProductDefinition.identifier
ingredient D	reference	Reference to a resource (by instance)	MedicinalProductDefinition.ingredient.reference
ingredient-code D	token	Reference to a concept (by class)	MedicinalProductDefinition.ingredient.concept
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.classification
status	token	The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status	MedicinalProductDefinition.status
type	token	Regulatory type, e.g. Investigational or Authorized	MedicinalProductDefinition.type