R4 Ballot #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.5.0: R4 Ballot #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

11.15 Resource MedicinalProductManufactured - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Trial Use

Compartments: Not linked to any defined compartments

The manufactured item as contained in the packaged medicinal product.

11.15.1 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 MedicinalProductPackaged

Structure

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductManufactured	Σ TU		DomainResource	The manufactured item as contained in the packaged medicinal product Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form as manufactured and before any transformation into the pharmaceutical product
unitOfPresentation	Σ	0..1	CodeableConcept	The “real world” units in which the quantity of the manufactured item is described
quantity	Σ	1..1	Quantity	The quantity or "count number" of the manufactured item
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)
ingredient	Σ	0..*	Reference(MedicinalProductIngredient)	Ingredient
physicalCharacteristics	Σ	0..1	ProdCharacteristic	Dimensions, color etc.
otherCharacteristics	Σ	0..*	CodeableConcept	Other codeable characteristics
Documentation for this format

UML Diagram (Legend)

XML Template

<MedicinalProductManufactured xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <manufacturedDoseForm><!-- 1..1 CodeableConcept Dose form as manufactured and before any transformation into the pharmaceutical product --></manufacturedDoseForm>
 <unitOfPresentation><!-- 0..1 CodeableConcept The “real world” units in which the quantity of the manufactured item is described --></unitOfPresentation>
 <quantity><!-- 1..1 Quantity The quantity or "count number" of the manufactured item --></quantity>
 <manufacturer><!-- 0..* Reference(Organization) Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues) --></manufacturer>
 <ingredient><!-- 0..* Reference(MedicinalProductIngredient) Ingredient --></ingredient>
 <physicalCharacteristics><!-- 0..1 ProdCharacteristic Dimensions, color etc. --></physicalCharacteristics>
 <otherCharacteristics><!-- 0..* CodeableConcept Other codeable characteristics --></otherCharacteristics>
</MedicinalProductManufactured>

JSON Template

{
  "resourceType" : "MedicinalProductManufactured",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "manufacturedDoseForm" : { CodeableConcept }, // R!  Dose form as manufactured and before any transformation into the pharmaceutical product
  "unitOfPresentation" : { CodeableConcept }, // The “real world” units in which the quantity of the manufactured item is described
  "quantity" : { Quantity }, // R!  The quantity or "count number" of the manufactured item
  "manufacturer" : [{ Reference(Organization) }], // Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)
  "ingredient" : [{ Reference(MedicinalProductIngredient) }], // Ingredient
  "physicalCharacteristics" : { ProdCharacteristic }, // Dimensions, color etc.
  "otherCharacteristics" : [{ CodeableConcept }] // Other codeable characteristics
}

Turtle Template

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


[ a fhir:MedicinalProductManufactured;
  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:MedicinalProductManufactured.manufacturedDoseForm [ CodeableConcept ]; # 1..1 Dose form as manufactured and before any transformation into the pharmaceutical product
  fhir:MedicinalProductManufactured.unitOfPresentation [ CodeableConcept ]; # 0..1 The “real world” units in which the quantity of the manufactured item is described
  fhir:MedicinalProductManufactured.quantity [ Quantity ]; # 1..1 The quantity or "count number" of the manufactured item
  fhir:MedicinalProductManufactured.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)
  fhir:MedicinalProductManufactured.ingredient [ Reference(MedicinalProductIngredient) ], ... ; # 0..* Ingredient
  fhir:MedicinalProductManufactured.physicalCharacteristics [ ProdCharacteristic ]; # 0..1 Dimensions, color etc.
  fhir:MedicinalProductManufactured.otherCharacteristics [ CodeableConcept ], ... ; # 0..* Other codeable characteristics
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.