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MedicinalProduct

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

Properties

NameRequiredTypeDescription
identifierIdentifier[]

Business identifier for this product. Could be an MPID

Details

Business identifier for this product. Could be an MPID.

typeCodeableConcept

Regulatory type, e.g. Investigational or Authorized

Details

Regulatory type, e.g. Investigational or Authorized.

domainCoding

If this medicine applies to human or veterinary uses

Details

If this medicine applies to human or veterinary uses.

combinedPharmaceuticalDoseFormCodeableConcept

The dose form for a single part product, or combined form of a multiple part product

Details

The dose form for a single part product, or combined form of a multiple part product.

legalStatusOfSupplyCodeableConcept

The legal status of supply of the medicinal product as classified by the regulator

Details

The legal status of supply of the medicinal product as classified by the regulator.

additionalMonitoringIndicatorCodeableConcept

Whether the Medicinal Product is subject to additional monitoring for regulatory reasons

Details

Whether the Medicinal Product is subject to additional monitoring for regulatory reasons.

specialMeasuresstring[]

Whether the Medicinal Product is subject to special measures for regulatory reasons

Details

Whether the Medicinal Product is subject to special measures for regulatory reasons.

paediatricUseIndicatorCodeableConcept

If authorised for use in children

Details

If authorised for use in children.

productClassificationCodeableConcept[]

Allows the product to be classified by various systems

Details

Allows the product to be classified by various systems.

marketingStatusMarketingStatus[]

Marketing status of the medicinal product, in contrast to marketing authorizaton

Details

Marketing status of the medicinal product, in contrast to marketing authorizaton.

pharmaceuticalProductReference<MedicinalProductPharmaceutical>[]

Pharmaceutical aspects of product

Details

Pharmaceutical aspects of product.

packagedMedicinalProductReference<MedicinalProductPackaged>[]

Package representation for the product

Details

Package representation for the product.

attachedDocumentReference<DocumentReference>[]

Supporting documentation, typically for regulatory submission

Details

Supporting documentation, typically for regulatory submission.

masterFileReference<DocumentReference>[]

A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)

Details

A master file for to the medicinal product (e.g. Pharmacovigilance System Master File).

contactReference<Organization | PractitionerRole>[]

A product specific contact, person (in a role), or an organization

Details

A product specific contact, person (in a role), or an organization.

clinicalTrialReference<ResearchStudy>[]

Clinical trials or studies that this product is involved in

Details

Clinical trials or studies that this product is involved in.

nameMedicinalProductName[]

The product's name, including full name and possibly coded parts

Details

The product's name, including full name and possibly coded parts.

idstring

Unique id for inter-element referencing

Details

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

extensionExtension[]

Additional content defined by implementations

Details

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

modifierExtensionExtension[]

Extensions that cannot be ignored even if unrecognized

Details

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

productNamestring

The full product name

Details

The full product name.

namePartMedicinalProductNameNamePart[]

Coding words or phrases of the name

Details

Coding words or phrases of the name.

idstring

Unique id for inter-element referencing

Details

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

extensionExtension[]

Additional content defined by implementations

Details

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

modifierExtensionExtension[]

Extensions that cannot be ignored even if unrecognized

Details

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

partstring

A fragment of a product name

Details

A fragment of a product name.

typeCoding

Idenifying type for this part of the name (e.g. strength part)

Details

Idenifying type for this part of the name (e.g. strength part).

countryLanguageMedicinalProductNameCountryLanguage[]

Country where the name applies

Details

Country where the name applies.

idstring

Unique id for inter-element referencing

Details

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

extensionExtension[]

Additional content defined by implementations

Details

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

modifierExtensionExtension[]

Extensions that cannot be ignored even if unrecognized

Details

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

countryCodeableConcept

Country code for where this name applies

Details

Country code for where this name applies.

jurisdictionCodeableConcept

Jurisdiction code for where this name applies

Details

Jurisdiction code for where this name applies.

languageCodeableConcept

Language code for this name

Details

Language code for this name.

crossReferenceIdentifier[]

Reference to another product, e.g. for linking authorised to investigational product

Details

Reference to another product, e.g. for linking authorised to investigational product.

manufacturingBusinessOperationMedicinalProductManufacturingBusinessOperation[]

An operation applied to the product, for manufacturing or adminsitrative purpose

Details

An operation applied to the product, for manufacturing or adminsitrative purpose.

idstring

Unique id for inter-element referencing

Details

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

extensionExtension[]

Additional content defined by implementations

Details

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

modifierExtensionExtension[]

Extensions that cannot be ignored even if unrecognized

Details

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

operationTypeCodeableConcept

The type of manufacturing operation

Details

The type of manufacturing operation.

authorisationReferenceNumberIdentifier

Regulatory authorization reference number

Details

Regulatory authorization reference number.

effectiveDatedateTime

Regulatory authorization date

Details

Regulatory authorization date.

confidentialityIndicatorCodeableConcept

To indicate if this proces is commercially confidential

Details

To indicate if this proces is commercially confidential.

manufacturerReference<Organization>[]

The manufacturer or establishment associated with the process

Details

The manufacturer or establishment associated with the process.

regulatorReference<Organization>

A regulator which oversees the operation

Details

A regulator which oversees the operation.

specialDesignationMedicinalProductSpecialDesignation[]

Indicates if the medicinal product has an orphan designation for the treatment of a rare disease

Details

Indicates if the medicinal product has an orphan designation for the treatment of a rare disease.

idstring

Unique id for inter-element referencing

Details

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

extensionExtension[]

Additional content defined by implementations

Details

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

modifierExtensionExtension[]

Extensions that cannot be ignored even if unrecognized

Details

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

identifierIdentifier[]

Identifier for the designation, or procedure number

Details

Identifier for the designation, or procedure number.

typeCodeableConcept

The type of special designation, e.g. orphan drug, minor use

Details

The type of special designation, e.g. orphan drug, minor use.

intendedUseCodeableConcept

The intended use of the product, e.g. prevention, treatment

Details

The intended use of the product, e.g. prevention, treatment.

indication[x]CodeableConcept, Reference<MedicinalProductIndication>

Condition for which the medicinal use applies

Details

Condition for which the medicinal use applies.

statusCodeableConcept

For example granted, pending, expired or withdrawn

Details

For example granted, pending, expired or withdrawn.

datedateTime

Date when the designation was granted

Details

Date when the designation was granted.

speciesCodeableConcept

Animal species for which this applies

Details

Animal species for which this applies.

Search Parameters

NameTypeDescriptionExpression
identifiertokenBusiness identifier for this product. Could be an MPIDMedicinalProduct.identifier
namestringThe full product nameMedicinalProduct.name.productName
name-languagetokenLanguage code for this nameMedicinalProduct.name.countryLanguage.language

Inherited Properties

NameRequiredTypeDescription
idstring

Logical id of this artifact

Details

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

metaMeta

Metadata about the resource

Details

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

implicitRulesuri

A set of rules under which this content was created

Details

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

languagecode

Language of the resource content

Details

The base language in which the resource is written.

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

textNarrative

Text summary of the resource, for human interpretation

Details

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

containedResource[]

Contained, inline Resources

Details

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

extensionExtension[]

Additional content defined by implementations

Details

May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

modifierExtensionExtension[]

Extensions that cannot be ignored

Details

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.