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15.1 Resource MedicinalProductDefinition - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 3

Trial Use

Security Category: Anonymous

Compartments: Not linked to any defined compartments

A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).

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 ManufacturedItemDefinition resource can be used. But that doesn't make the tablet into a "product" - it is still just the physical manifestation of an overall drug product. There is logically a MedicinalProductDefinition there too, even if it is not being used or transmitted at this time.)

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

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

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

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

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

15.1.1.1 Authorisations

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.

15.1.1.2 Contained Resources

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

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

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

This example demonstrates both of these cases.

15.1.2 References to this Resource

Resource References: : ActivityDefinition, AdministrableProductDefinition, ClinicalUseDefinition, Ingredient, MedicationKnowledge... Show 4 more

Structure

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition	TU		DomainResource	Detailed definition of a medicinal product 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 MedicinalProductType (Example)
domain	Σ	0..1	CodeableConcept	If this medicine applies to human or veterinary uses MedicinalProductDomain (Example)
version	Σ	0..1	string	A business identifier relating to a specific version of the product
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record 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 CombinedDoseForm (Example)
route	Σ	0..*	CodeableConcept	The path by which the product is taken into or makes contact with the body SNOMED CT Route Codes (Example)
indication	Σ	0..1	markdown	Description of indication(s) for this product, used when structured indications are not required
legalStatusOfSupply	Σ	0..1	CodeableConcept	The legal status of supply of the medicinal product as classified by the regulator LegalStatusOfSupply (Example)
additionalMonitoringIndicator	Σ	0..1	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons AdditionalMonitoring (Example)
specialMeasures	Σ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons SpecialMeasures (Example)
pediatricUseIndicator	Σ	0..1	CodeableConcept	If authorised for use in children PediatricUse (Example)
classification	Σ	0..*	CodeableConcept	Allows the product to be classified by various systems ProductClassification (Example)
marketingStatus	Σ	0..*	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorization
packagedMedicinalProduct	Σ	0..*	CodeableConcept	Package type for the product MedicinalProductPackageType (Example)
comprisedOf	Σ	0..*	Reference(ManufacturedItemDefinition \| DeviceDefinition)	Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
ingredient	Σ	0..*	CodeableConcept	The ingredients of this medicinal product - when not detailed in other resources SNOMED CT Substance Codes (Example)
impurity	Σ	0..*	CodeableReference(SubstanceDefinition)	Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product SNOMED CT Substance Codes (Example)
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional documentation about the medicinal product
masterFile	Σ	0..*	Reference(DocumentReference)	A master file for 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 ProductContactType (Example)
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
code	Σ	0..*	Coding	A code that this product is known by, within some formal terminology SNOMED CT Medication Codes (Example)
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 ProductNameType (Example)
part	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) ProductNamePartType (Example)
usage	Σ	0..*	BackboneElement	Country and jurisdiction where the name applies
country	Σ	1..1	CodeableConcept	Country code for where this name applies Country (Example)
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction code for where this name applies Jurisdiction (Example)
language	Σ	1..1	CodeableConcept	Language code for this name Common Languages (Preferred but limited to AllLanguages)
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 or virtual to actual product ProductCrossReferenceType (Example)
operation	Σ	0..*	BackboneElement	A manufacturing or administrative process for the medicinal product
type	Σ	0..1	CodeableReference(ActivityDefinition \| PlanDefinition)	The type of manufacturing operation e.g. manufacturing itself, re-packaging
effectiveDate	Σ	0..1	Period	Date range of applicability
organization	Σ	0..*	Reference(Organization)	The organization responsible for the particular process, e.g. the manufacturer or importer
confidentialityIndicator	Σ	0..1	CodeableConcept	Specifies whether this process is considered proprietary or confidential ProductConfidentiality (Example)
characteristic	Σ	0..*	BackboneElement	Key product features such as "sugar free", "modified release"
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic ProductCharacteristic (Example)
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueString			string
valueQuantity			Quantity
valueInteger			integer
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
Documentation for this format

See the Extensions for this resource

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

JSON Template

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

Turtle Template

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


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

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

Changes since R4

This resource did not exist in Release 3

This analysis is available as XML or JSON.

Structure

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition	TU		DomainResource	Detailed definition of a medicinal product 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 MedicinalProductType (Example)
domain	Σ	0..1	CodeableConcept	If this medicine applies to human or veterinary uses MedicinalProductDomain (Example)
version	Σ	0..1	string	A business identifier relating to a specific version of the product
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record 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 CombinedDoseForm (Example)
route	Σ	0..*	CodeableConcept	The path by which the product is taken into or makes contact with the body SNOMED CT Route Codes (Example)
indication	Σ	0..1	markdown	Description of indication(s) for this product, used when structured indications are not required
legalStatusOfSupply	Σ	0..1	CodeableConcept	The legal status of supply of the medicinal product as classified by the regulator LegalStatusOfSupply (Example)
additionalMonitoringIndicator	Σ	0..1	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons AdditionalMonitoring (Example)
specialMeasures	Σ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons SpecialMeasures (Example)
pediatricUseIndicator	Σ	0..1	CodeableConcept	If authorised for use in children PediatricUse (Example)
classification	Σ	0..*	CodeableConcept	Allows the product to be classified by various systems ProductClassification (Example)
marketingStatus	Σ	0..*	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorization
packagedMedicinalProduct	Σ	0..*	CodeableConcept	Package type for the product MedicinalProductPackageType (Example)
comprisedOf	Σ	0..*	Reference(ManufacturedItemDefinition \| DeviceDefinition)	Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
ingredient	Σ	0..*	CodeableConcept	The ingredients of this medicinal product - when not detailed in other resources SNOMED CT Substance Codes (Example)
impurity	Σ	0..*	CodeableReference(SubstanceDefinition)	Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product SNOMED CT Substance Codes (Example)
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional documentation about the medicinal product
masterFile	Σ	0..*	Reference(DocumentReference)	A master file for 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 ProductContactType (Example)
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
code	Σ	0..*	Coding	A code that this product is known by, within some formal terminology SNOMED CT Medication Codes (Example)
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 ProductNameType (Example)
part	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) ProductNamePartType (Example)
usage	Σ	0..*	BackboneElement	Country and jurisdiction where the name applies
country	Σ	1..1	CodeableConcept	Country code for where this name applies Country (Example)
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction code for where this name applies Jurisdiction (Example)
language	Σ	1..1	CodeableConcept	Language code for this name Common Languages (Preferred but limited to AllLanguages)
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 or virtual to actual product ProductCrossReferenceType (Example)
operation	Σ	0..*	BackboneElement	A manufacturing or administrative process for the medicinal product
type	Σ	0..1	CodeableReference(ActivityDefinition \| PlanDefinition)	The type of manufacturing operation e.g. manufacturing itself, re-packaging
effectiveDate	Σ	0..1	Period	Date range of applicability
organization	Σ	0..*	Reference(Organization)	The organization responsible for the particular process, e.g. the manufacturer or importer
confidentialityIndicator	Σ	0..1	CodeableConcept	Specifies whether this process is considered proprietary or confidential ProductConfidentiality (Example)
characteristic	Σ	0..*	BackboneElement	Key product features such as "sugar free", "modified release"
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic ProductCharacteristic (Example)
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueString			string
valueQuantity			Quantity
valueInteger			integer
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
Documentation for this format

See the Extensions for this resource

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

JSON Template

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

Turtle Template

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


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

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

Changes since Release 4

This resource did not exist in Release 3

This analysis is available as XML or JSON.

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

15.1.3.1 Terminology Bindings

Path	Definition	Type	Reference
MedicinalProductDefinition.type	Overall defining type of this Medicinal Product.	Example	MedicinalProductType
MedicinalProductDefinition.domain	Applicable domain for this product (e.g. human, veterinary)	Example	MedicinalProductDomain
MedicinalProductDefinition.status	The lifecycle status of an artifact.	Preferred	PublicationStatus
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	Dose forms for a product as a whole, considering all individual parts, but before any mixing	Example	CombinedDoseForm
MedicinalProductDefinition.route	This value set includes all Route codes from SNOMED CT - provided as an exemplar.	Example	SNOMEDCTRouteCodes
MedicinalProductDefinition.legalStatusOfSupply	The prescription supply types appropriate to a medicinal product	Example	LegalStatusOfSupply
MedicinalProductDefinition.additionalMonitoringIndicator	Extra monitoring defined for a Medicinal Product.	Example	AdditionalMonitoring
MedicinalProductDefinition.specialMeasures	Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorisation studies.	Example	SpecialMeasures
MedicinalProductDefinition.pediatricUseIndicator	Extra measures defined for a Medicinal Product, such as heightened reporting requirements.	Example	PediatricUse
MedicinalProductDefinition.classification	This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.	Example	ProductClassification
MedicinalProductDefinition.packagedMedicinalProduct	Types of medicinal product packs	Example	MedicinalProductPackageType
MedicinalProductDefinition.ingredient	This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.	Example	SNOMEDCTSubstanceCodes
MedicinalProductDefinition.impurity	This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.	Example	SNOMEDCTSubstanceCodes
MedicinalProductDefinition.contact.type	Contact type for a Medicinal Product.	Example	ProductContactType
MedicinalProductDefinition.code	This value set includes all drug or medicament substance codes and all pharmaceutical/biologic products from SNOMED CT - provided as an exemplar value set.	Example	SNOMEDCTMedicationCodes
MedicinalProductDefinition.name.type	Type of a name for a Medicinal Product.	Example	ProductNameType
MedicinalProductDefinition.name.part.type	Type of part of a name for a Medicinal Product.	Example	ProductNamePartType
MedicinalProductDefinition.name.usage.country	This value set defines a base set of codes for countries. Note: The codes for countries are taken from ISO 3166 .	Example	Country ValueSet
MedicinalProductDefinition.name.usage.jurisdiction	This value set defines a base set of codes for country, country subdivision and region for indicating where a resource is intended to be used. Note: The codes for countries and country subdivisions are taken from ISO 3166 while the codes for "supra-national" regions are from UN Standard country or area codes for statistical use (M49) .	Example	Jurisdiction ValueSet
MedicinalProductDefinition.name.usage.language	This value set includes common codes from BCP-47 (http://tools.ietf.org/html/bcp47)	Preferred, but limited to AllLanguages	CommonLanguages
MedicinalProductDefinition.crossReference.type	Relationship to another Medicinal Product.	Example	ProductCrossReferenceType
MedicinalProductDefinition.operation.confidentialityIndicator	Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.	Example	ProductConfidentiality
MedicinalProductDefinition.characteristic.type	This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.	Example	ProductCharacteristic

Path

Definition

Type

Reference

MedicinalProductDefinition.type

Overall defining type of this Medicinal Product.

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.value
characteristic-type	token	A category for the characteristic	MedicinalProductDefinition.characteristic.type
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	token	An ingredient of this product	MedicinalProductDefinition.ingredient
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.usage.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