Release 4B Snapshot #1
Medication DefinitionThis page is part of the FHIR Specification v4.3.0-snapshot1: R4B Snapshot to support the Jan 2022 Connectathon. About the R4B version of FHIR. The current officially released version is 4.3.0. For a full list of available versions, see the Directory of published versions 
. Page versions: R5 R4B
| 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).
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.
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 demonstates both of these cases.
This resource is referenced by AdministrableProductDefinition, ClinicalUseDefinition, Ingredient, itself, 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 MedicinalProductType (Example) |
| domain | Σ | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses MedicinalProductType (Example) |
 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 CombinedDoseForm (Example) |
| 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. See also AdministrableProductDefinition resource SNOMED CT Route Codes (Example) |
| 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 ClinicalUseDefinition 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 LegalStatusOfSupply (Example) |
| 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 |
| pediatricUseIndicator | Σ | 0..1 | CodeableConcept | If authorised for use in children |
| classification | Σ | 0..* | CodeableConcept | Allows the product to be classified by various systems |
| marketingStatus | Σ | 0..* | MarketingStatus | Marketing status of the medicinal product, in contrast to marketing authorization |
| packagedMedicinalProduct | Σ | 0..* | CodeableConcept | Package representation for the product MedicinalProductPackageType (Example) |
| ingredient | Σ | 0..* | CodeableConcept | The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes |
 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. 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 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 |
| 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 |
| 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 | PlanDefinition) | The type of manufacturing operation e.g. manufacturing itself, re-packaging. For the authorization of this, a RegulatedAuthorization would point to the same plan or activity referenced here |
| 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 |
| confidentialityIndicator | Σ | 0..1 | CodeableConcept | Specifies whether this particular business or manufacturing process is considered proprietary or confidential |
| characteristic | Σ | 0..* | BackboneElement | Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import" |
| type | Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic |
 value[x] | Σ | 0..1 | A value for the characteristic | |
| valueCodeableConcept | CodeableConcept | |||
| valueQuantity | Quantity | |||
| valueDate | date | |||
| valueBoolean | boolean | |||
| valueAttachment | Attachment | |||
| 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
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
"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. See also AdministrableProductDefinition resource
"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 ClinicalUseDefinition 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
"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 representation for the product
"ingredient" : [{ CodeableConcept }], // The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes
"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. 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 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
"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|PlanDefinition) }, // The type of manufacturing operation e.g. manufacturing itself, re-packaging. For the authorization of this, a RegulatedAuthorization would point to the same plan or activity referenced here
"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
"confidentialityIndicator" : { CodeableConcept } // Specifies whether this particular business or manufacturing process is considered proprietary or confidential
}],
"characteristic" : [{ // Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"
"type" : { CodeableConcept }, // R! A code expressing the type of characteristic
// value[x]: A value for the characteristic. One of these 5:
"valueCodeableConcept" : { CodeableConcept }
"valueQuantity" : { Quantity }
"valueDate" : "<date>"
"valueBoolean" : <boolean>
"valueAttachment" : { Attachment }
}]
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .
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 MedicinalProductType (Example) |
| domain | Σ | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses MedicinalProductType (Example) |
| 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 CombinedDoseForm (Example) |
| 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. See also AdministrableProductDefinition resource SNOMED CT Route Codes (Example) |
| 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 ClinicalUseDefinition 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 LegalStatusOfSupply (Example) |
| 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 |
| pediatricUseIndicator | Σ | 0..1 | CodeableConcept | If authorised for use in children |
| classification | Σ | 0..* | CodeableConcept | Allows the product to be classified by various systems |
| marketingStatus | Σ | 0..* | MarketingStatus | Marketing status of the medicinal product, in contrast to marketing authorization |
| packagedMedicinalProduct | Σ | 0..* | CodeableConcept | Package representation for the product MedicinalProductPackageType (Example) |
| ingredient | Σ | 0..* | CodeableConcept | The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes |
| 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. 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 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 |
| 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 |
| 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 | PlanDefinition) | The type of manufacturing operation e.g. manufacturing itself, re-packaging. For the authorization of this, a RegulatedAuthorization would point to the same plan or activity referenced here |
| 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 |
| confidentialityIndicator | Σ | 0..1 | CodeableConcept | Specifies whether this particular business or manufacturing process is considered proprietary or confidential |
| characteristic | Σ | 0..* | BackboneElement | Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import" |
| type | Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic |
| value[x] | Σ | 0..1 | A value for the characteristic | |
| valueCodeableConcept | CodeableConcept | |||
| valueQuantity | Quantity | |||
| valueDate | date | |||
| valueBoolean | boolean | |||
| valueAttachment | Attachment | |||
| Documentation for this format | ||||
XML Template
<MedicinalProductDefinition xmlns="http://hl7.org/fhir">
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
"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. See also AdministrableProductDefinition resource
"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 ClinicalUseDefinition 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
"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 representation for the product
"ingredient" : [{ CodeableConcept }], // The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes
"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. 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 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
"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|PlanDefinition) }, // The type of manufacturing operation e.g. manufacturing itself, re-packaging. For the authorization of this, a RegulatedAuthorization would point to the same plan or activity referenced here
"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
"confidentialityIndicator" : { CodeableConcept } // Specifies whether this particular business or manufacturing process is considered proprietary or confidential
}],
"characteristic" : [{ // Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"
"type" : { CodeableConcept }, // R! A code expressing the type of characteristic
// value[x]: A value for the characteristic. One of these 5:
"valueCodeableConcept" : { CodeableConcept }
"valueQuantity" : { Quantity }
"valueDate" : "<date>"
"valueBoolean" : <boolean>
"valueAttachment" : { Attachment }
}]
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .
See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions & the dependency analysis
| Path | Definition | Type | Reference |
|---|---|---|---|
| MedicinalProductDefinition.type | Example | http://hl7.org/fhir/ValueSet/medicinal-product-type | |
| MedicinalProductDefinition.domain | Example | http://hl7.org/fhir/ValueSet/medicinal-product-domain | |
| MedicinalProductDefinition.status | Preferred | PublicationStatus | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | Example | http://hl7.org/fhir/ValueSet/combined-dose-form | |
| MedicinalProductDefinition.route | Example | SNOMEDCTRouteCodes | |
| MedicinalProductDefinition.legalStatusOfSupply | Example | http://hl7.org/fhir/ValueSet/legal-status-of-supply | |
| MedicinalProductDefinition.packagedMedicinalProduct | Example | http://hl7.org/fhir/ValueSet/medicinal-product-package-type | |
| MedicinalProductDefinition.code | Example | SNOMEDCTMedicationCodes |
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.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.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 |
FHIR ®© HL7.org 2011+. FHIR R4B Ballot #1 hl7.fhir.core#4.3.0-snapshot1 generated on Mon, Dec 20, 2021 14:14+1100.
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