MedicinalProduct

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

Schema

Elements

Name	Required	Type	Description
identifier		Identifier[]	Business identifier for this product. Could be an MPID Details Business identifier for this product. Could be an MPID.
type		CodeableConcept	Regulatory type, e.g. Investigational or Authorized Details Regulatory type, e.g. Investigational or Authorized.
domain		Coding	If this medicine applies to human or veterinary uses Details If this medicine applies to human or veterinary uses.
combinedPharmaceuticalDoseForm		CodeableConcept	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.
legalStatusOfSupply		CodeableConcept	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.
additionalMonitoringIndicator		CodeableConcept	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.
specialMeasures		string[]	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.
paediatricUseIndicator		CodeableConcept	If authorised for use in children Details If authorised for use in children.
productClassification		CodeableConcept[]	Allows the product to be classified by various systems Details Allows the product to be classified by various systems.
marketingStatus		MarketingStatus[]	Marketing status of the medicinal product, in contrast to marketing authorizaton Details Marketing status of the medicinal product, in contrast to marketing authorizaton.
pharmaceuticalProduct		Reference<MedicinalProductPharmaceutical>[]	Pharmaceutical aspects of product Details Pharmaceutical aspects of product.
packagedMedicinalProduct		Reference<MedicinalProductPackaged>[]	Package representation for the product Details Package representation for the product.
attachedDocument		Reference<DocumentReference>[]	Supporting documentation, typically for regulatory submission Details Supporting documentation, typically for regulatory submission.
masterFile		Reference<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).
contact		Reference<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.
clinicalTrial		Reference<ResearchStudy>[]	Clinical trials or studies that this product is involved in Details Clinical trials or studies that this product is involved in.
name	✓	MedicinalProductName[]	The product's name, including full name and possibly coded parts Details The product's name, including full name and possibly coded parts.
id		string	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.
extension		Extension[]	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.
modifierExtension		Extension[]	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.
productName	✓	string	The full product name Details The full product name.
namePart		MedicinalProductNameNamePart[]	Coding words or phrases of the name Details Coding words or phrases of the name.
id		string	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.
extension		Extension[]	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.
modifierExtension		Extension[]	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.
part	✓	string	A fragment of a product name Details A fragment of a product name.
type	✓	Coding	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).
countryLanguage		MedicinalProductNameCountryLanguage[]	Country where the name applies Details Country where the name applies.
id		string	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.
extension		Extension[]	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.
modifierExtension		Extension[]	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.
country	✓	CodeableConcept	Country code for where this name applies Details Country code for where this name applies.
jurisdiction		CodeableConcept	Jurisdiction code for where this name applies Details Jurisdiction code for where this name applies.
language	✓	CodeableConcept	Language code for this name Details Language code for this name.
crossReference		Identifier[]	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.
manufacturingBusinessOperation		MedicinalProductManufacturingBusinessOperation[]	An operation applied to the product, for manufacturing or adminsitrative purpose Details An operation applied to the product, for manufacturing or adminsitrative purpose.
id		string	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.
extension		Extension[]	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.
modifierExtension		Extension[]	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.
operationType		CodeableConcept	The type of manufacturing operation Details The type of manufacturing operation.
authorisationReferenceNumber		Identifier	Regulatory authorization reference number Details Regulatory authorization reference number.
effectiveDate		dateTime	Regulatory authorization date Details Regulatory authorization date.
confidentialityIndicator		CodeableConcept	To indicate if this proces is commercially confidential Details To indicate if this proces is commercially confidential.
manufacturer		Reference<Organization>[]	The manufacturer or establishment associated with the process Details The manufacturer or establishment associated with the process.
regulator		Reference<Organization>	A regulator which oversees the operation Details A regulator which oversees the operation.
specialDesignation		MedicinalProductSpecialDesignation[]	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.
id		string	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.
extension		Extension[]	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.
modifierExtension		Extension[]	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.
identifier		Identifier[]	Identifier for the designation, or procedure number Details Identifier for the designation, or procedure number.
type		CodeableConcept	The type of special designation, e.g. orphan drug, minor use Details The type of special designation, e.g. orphan drug, minor use.
intendedUse		CodeableConcept	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.
status		CodeableConcept	For example granted, pending, expired or withdrawn Details For example granted, pending, expired or withdrawn.
date		dateTime	Date when the designation was granted Details Date when the designation was granted.
species		CodeableConcept	Animal species for which this applies Details Animal species for which this applies.

Search Parameters

Name	Type	Description	Expression
identifier	token	Business identifier for this product. Could be an MPID	MedicinalProduct.identifier
name	string	The full product name	MedicinalProduct.name.productName
name-language	token	Language code for this name	MedicinalProduct.name.countryLanguage.language

Inherited Elements

Name	Required	Type	Description
id		string	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.
meta		Meta	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.
implicitRules		uri	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.
language		code	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).
text		Narrative	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.
contained		Resource[]	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.
extension		Extension[]	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.
modifierExtension		Extension[]	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.

Usage

This resource is still undergoing development and review by the appropriate Workgroups. At this time, is considered only as a draft resource not suitable for production implementation

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]

Referenced By

• MedicinalProductAuthorization
• MedicinalProductContraindication
• MedicinalProductIndication
• MedicinalProductInteraction
• MedicinalProductPackaged
• MedicinalProductUndesirableEffect