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11.6 Resource MedicinalProduct - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Draft

Compartments: Not linked to any defined compartments

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

11.6.1 Scope and Usage

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

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

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

This resource is referenced by medicinalproductclinicals

Structure

Name	Flags	Card.	Type	Description & Constraints
MedicinalProduct	Σ D		DomainResource	Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use) Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	1..1	Identifier	Business idenfifier for this product. Could be an MPID
type	Σ	0..1	CodeableConcept	Regulatory type, e.g. Investigational or Authorized
combinedPharmaceuticalDoseForm	Σ	0..1	CodeableConcept	The dose form for a single part product, or combined form of a multiple part product
additionalMonitoringIndicator	Σ	0..1	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
specialMeasures	Σ	0..*	string	Whether the Medicinal Product is subject to special measures for regulatory reasons
paediatricUseIndicator	Σ	0..1	CodeableConcept	If authorised for use in children
orphanDesignationStatus	Σ	0..1	CodeableConcept	Indicates if the medicinal product has an orphan designation for the treatment of a rare disease
productClassification	Σ	0..*	CodeableConcept	Allows the product to be classified by various systems
marketingAuthorization	Σ	0..1	Reference(MedicinalProductAuthorization)	Product regulatory authorization
packagedMedicinalProduct	Σ	0..*	Reference(MedicinalProductPackaged)	Package representation for the product
pharmaceuticalProduct	Σ	0..*	Reference(MedicinalProductPharmaceutical)	Pharmaceutical aspects of product
clinicalParticulars	Σ	0..*	Reference(MedicinalProductClinicals)	Clinical particulars, indications etc.
attachedDocument	Σ	0..*	Reference(DocumentReference)	Supporting documentation, typically for regulatory submission
masterFile	Σ	0..*	Reference(DocumentReference)	A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
name	Σ	1..*	BackboneElement	The product's name, including full name and possibly coded parts
fullName	Σ	1..1	string	The full product name
namePart	Σ	0..*	BackboneElement	Coding words or phrases of the name
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	Coding	Idenifying type for this part of the name (e.g. strength part)
countryLanguage	Σ	0..*	BackboneElement	Country where the name applies
country	Σ	1..1	CodeableConcept	Country code for where this name applies
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction code for where this name applies
language	Σ	1..1	CodeableConcept	Language code for this name
crossReference	Σ	0..*	Identifier	Reference to another product, e.g. for linking authorised to investigational product
manufacturingBusinessOperation	Σ	0..*	BackboneElement	An operation applied to the product, for manufacturing or adminsitrative purpose
operationType	Σ	0..1	CodeableConcept	The type of manufacturing operation
authorisationReferenceNumber	Σ	0..1	Identifier	Regulatory authorization reference number
effectiveDate	Σ	0..1	dateTime	Regulatory authorization date
confidentialityIndicator	Σ	0..1	CodeableConcept	To indicate if this proces is commercially confidential
manufacturer	Σ	0..*	Reference(Organization)	The manufacturer or establishment associated with the process
regulator	Σ	0..1	Reference(Organization)	A regulator which oversees the operation
Documentation for this format

UML Diagram (Legend)

XML Template

<MedicinalProduct xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 1..1 Identifier Business idenfifier for this product. Could be an MPID --></identifier>
 <type><!-- 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized --></type>
 <combinedPharmaceuticalDoseForm><!-- 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product --></combinedPharmaceuticalDoseForm>
 <additionalMonitoringIndicator><!-- 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons --></additionalMonitoringIndicator>
 <specialMeasures value="[string]"/><!-- 0..* Whether the Medicinal Product is subject to special measures for regulatory reasons -->
 <paediatricUseIndicator><!-- 0..1 CodeableConcept If authorised for use in children --></paediatricUseIndicator>
 <orphanDesignationStatus><!-- 0..1 CodeableConcept Indicates if the medicinal product has an orphan designation for the treatment of a rare disease --></orphanDesignationStatus>
 <productClassification><!-- 0..* CodeableConcept Allows the product to be classified by various systems --></productClassification>
 <marketingAuthorization><!-- 0..1 Reference(MedicinalProductAuthorization) Product regulatory authorization --></marketingAuthorization>
 <packagedMedicinalProduct><!-- 0..* Reference(MedicinalProductPackaged) Package representation for the product --></packagedMedicinalProduct>
 <pharmaceuticalProduct><!-- 0..* Reference(MedicinalProductPharmaceutical) Pharmaceutical aspects of product --></pharmaceuticalProduct>
 <clinicalParticulars><!-- 0..* Reference(MedicinalProductClinicals) Clinical particulars, indications etc. --></clinicalParticulars>
 <attachedDocument><!-- 0..* Reference(DocumentReference) Supporting documentation, typically for regulatory submission --></attachedDocument>
 <masterFile><!-- 0..* Reference(DocumentReference) A master file for to the medicinal product (e.g. Pharmacovigilance System Master File) --></masterFile>
 <name>  <!-- 1..* The product's name, including full name and possibly coded parts -->
  <fullName value="[string]"/><!-- 1..1 The full product name -->
  <namePart>  <!-- 0..* Coding words or phrases of the name -->
   <part value="[string]"/><!-- 1..1 A fragment of a product name -->
   <type><!-- 1..1 Coding Idenifying type for this part of the name (e.g. strength part) --></type>
  </namePart>
  <countryLanguage>  <!-- 0..* Country where the name applies -->
   <country><!-- 1..1 CodeableConcept Country code for where this name applies --></country>
   <jurisdiction><!-- 0..1 CodeableConcept Jurisdiction code for where this name applies --></jurisdiction>
   <language><!-- 1..1 CodeableConcept Language code for this name --></language>
  </countryLanguage>
 </name>
 <crossReference><!-- 0..* Identifier Reference to another product, e.g. for linking authorised to investigational product --></crossReference>
 <manufacturingBusinessOperation>  <!-- 0..* An operation applied to the product, for manufacturing or adminsitrative purpose -->
  <operationType><!-- 0..1 CodeableConcept The type of manufacturing operation --></operationType>
  <authorisationReferenceNumber><!-- 0..1 Identifier Regulatory authorization reference number --></authorisationReferenceNumber>
  <effectiveDate value="[dateTime]"/><!-- 0..1 Regulatory authorization date -->
  <confidentialityIndicator><!-- 0..1 CodeableConcept To indicate if this proces is commercially confidential --></confidentialityIndicator>
  <manufacturer><!-- 0..* Reference(Organization) The manufacturer or establishment associated with the process --></manufacturer>
  <regulator><!-- 0..1 Reference(Organization) A regulator which oversees the operation --></regulator>
 </manufacturingBusinessOperation>
</MedicinalProduct>

JSON Template

{
  "resourceType" : "MedicinalProduct",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : { Identifier }, // R!  Business idenfifier for this product. Could be an MPID
  "type" : { CodeableConcept }, // Regulatory type, e.g. Investigational or Authorized
  "combinedPharmaceuticalDoseForm" : { CodeableConcept }, // The dose form for a single part product, or combined form of a multiple part product
  "additionalMonitoringIndicator" : { CodeableConcept }, // Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
  "specialMeasures" : ["<string>"], // Whether the Medicinal Product is subject to special measures for regulatory reasons
  "paediatricUseIndicator" : { CodeableConcept }, // If authorised for use in children
  "orphanDesignationStatus" : { CodeableConcept }, // Indicates if the medicinal product has an orphan designation for the treatment of a rare disease
  "productClassification" : [{ CodeableConcept }], // Allows the product to be classified by various systems
  "marketingAuthorization" : { Reference(MedicinalProductAuthorization) }, // Product regulatory authorization
  "packagedMedicinalProduct" : [{ Reference(MedicinalProductPackaged) }], // Package representation for the product
  "pharmaceuticalProduct" : [{ Reference(MedicinalProductPharmaceutical) }], // Pharmaceutical aspects of product
  "clinicalParticulars" : [{ Reference(MedicinalProductClinicals) }], // Clinical particulars, indications etc.
  "attachedDocument" : [{ Reference(DocumentReference) }], // Supporting documentation, typically for regulatory submission
  "masterFile" : [{ Reference(DocumentReference) }], // A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
  "name" : [{ // R!  The product's name, including full name and possibly coded parts
    "fullName" : "<string>", // R!  The full product name
    "namePart" : [{ // Coding words or phrases of the name
      "part" : "<string>", // R!  A fragment of a product name
      "type" : { Coding } // R!  Idenifying type for this part of the name (e.g. strength part)
    }],
    "countryLanguage" : [{ // Country where the name applies
      "country" : { CodeableConcept }, // R!  Country code for where this name applies
      "jurisdiction" : { CodeableConcept }, // Jurisdiction code for where this name applies
      "language" : { CodeableConcept } // R!  Language code for this name
    }]
  }],
  "crossReference" : [{ Identifier }], // Reference to another product, e.g. for linking authorised to investigational product
  "manufacturingBusinessOperation" : [{ // An operation applied to the product, for manufacturing or adminsitrative purpose
    "operationType" : { CodeableConcept }, // The type of manufacturing operation
    "authorisationReferenceNumber" : { Identifier }, // Regulatory authorization reference number
    "effectiveDate" : "<dateTime>", // Regulatory authorization date
    "confidentialityIndicator" : { CodeableConcept }, // To indicate if this proces is commercially confidential
    "manufacturer" : [{ Reference(Organization) }], // The manufacturer or establishment associated with the process
    "regulator" : { Reference(Organization) } // A regulator which oversees the operation
  }]
}

Turtle Template

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


[ a fhir:MedicinalProduct;
  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:MedicinalProduct.identifier [ Identifier ]; # 1..1 Business idenfifier for this product. Could be an MPID
  fhir:MedicinalProduct.type [ CodeableConcept ]; # 0..1 Regulatory type, e.g. Investigational or Authorized
  fhir:MedicinalProduct.combinedPharmaceuticalDoseForm [ CodeableConcept ]; # 0..1 The dose form for a single part product, or combined form of a multiple part product
  fhir:MedicinalProduct.additionalMonitoringIndicator [ CodeableConcept ]; # 0..1 Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
  fhir:MedicinalProduct.specialMeasures [ string ], ... ; # 0..* Whether the Medicinal Product is subject to special measures for regulatory reasons
  fhir:MedicinalProduct.paediatricUseIndicator [ CodeableConcept ]; # 0..1 If authorised for use in children
  fhir:MedicinalProduct.orphanDesignationStatus [ CodeableConcept ]; # 0..1 Indicates if the medicinal product has an orphan designation for the treatment of a rare disease
  fhir:MedicinalProduct.productClassification [ CodeableConcept ], ... ; # 0..* Allows the product to be classified by various systems
  fhir:MedicinalProduct.marketingAuthorization [ Reference(MedicinalProductAuthorization) ]; # 0..1 Product regulatory authorization
  fhir:MedicinalProduct.packagedMedicinalProduct [ Reference(MedicinalProductPackaged) ], ... ; # 0..* Package representation for the product
  fhir:MedicinalProduct.pharmaceuticalProduct [ Reference(MedicinalProductPharmaceutical) ], ... ; # 0..* Pharmaceutical aspects of product
  fhir:MedicinalProduct.clinicalParticulars [ Reference(MedicinalProductClinicals) ], ... ; # 0..* Clinical particulars, indications etc.
  fhir:MedicinalProduct.attachedDocument [ Reference(DocumentReference) ], ... ; # 0..* Supporting documentation, typically for regulatory submission
  fhir:MedicinalProduct.masterFile [ Reference(DocumentReference) ], ... ; # 0..* A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
  fhir:MedicinalProduct.name [ # 1..* The product's name, including full name and possibly coded parts
    fhir:MedicinalProduct.name.fullName [ string ]; # 1..1 The full product name
    fhir:MedicinalProduct.name.namePart [ # 0..* Coding words or phrases of the name
      fhir:MedicinalProduct.name.namePart.part [ string ]; # 1..1 A fragment of a product name
      fhir:MedicinalProduct.name.namePart.type [ Coding ]; # 1..1 Idenifying type for this part of the name (e.g. strength part)
    ], ...;
    fhir:MedicinalProduct.name.countryLanguage [ # 0..* Country where the name applies
      fhir:MedicinalProduct.name.countryLanguage.country [ CodeableConcept ]; # 1..1 Country code for where this name applies
      fhir:MedicinalProduct.name.countryLanguage.jurisdiction [ CodeableConcept ]; # 0..1 Jurisdiction code for where this name applies
      fhir:MedicinalProduct.name.countryLanguage.language [ CodeableConcept ]; # 1..1 Language code for this name
    ], ...;
  ], ...;
  fhir:MedicinalProduct.crossReference [ Identifier ], ... ; # 0..* Reference to another product, e.g. for linking authorised to investigational product
  fhir:MedicinalProduct.manufacturingBusinessOperation [ # 0..* An operation applied to the product, for manufacturing or adminsitrative purpose
    fhir:MedicinalProduct.manufacturingBusinessOperation.operationType [ CodeableConcept ]; # 0..1 The type of manufacturing operation
    fhir:MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber [ Identifier ]; # 0..1 Regulatory authorization reference number
    fhir:MedicinalProduct.manufacturingBusinessOperation.effectiveDate [ dateTime ]; # 0..1 Regulatory authorization date
    fhir:MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator [ CodeableConcept ]; # 0..1 To indicate if this proces is commercially confidential
    fhir:MedicinalProduct.manufacturingBusinessOperation.manufacturer [ Reference(Organization) ], ... ; # 0..* The manufacturer or establishment associated with the process
    fhir:MedicinalProduct.manufacturingBusinessOperation.regulator [ Reference(Organization) ]; # 0..1 A regulator which oversees the operation
  ], ...;
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.