Resource type: medicinalproduct

Description

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

Elements

PathShortDefinitionComments
Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use).
identifierBusiness identifier for this product. Could be an MPIDBusiness identifier for this product. Could be an MPID.
typeRegulatory type, e.g. Investigational or AuthorizedRegulatory type, e.g. Investigational or Authorized.
domainIf this medicine applies to human or veterinary usesIf this medicine applies to human or veterinary uses.
combinedPharmaceuticalDoseFormThe dose form for a single part product, or combined form of a multiple part productThe dose form for a single part product, or combined form of a multiple part product.
legalStatusOfSupplyThe legal status of supply of the medicinal product as classified by the regulatorThe legal status of supply of the medicinal product as classified by the regulator.
additionalMonitoringIndicatorWhether the Medicinal Product is subject to additional monitoring for regulatory reasonsWhether the Medicinal Product is subject to additional monitoring for regulatory reasons.
specialMeasuresWhether the Medicinal Product is subject to special measures for regulatory reasonsWhether the Medicinal Product is subject to special measures for regulatory reasons.
paediatricUseIndicatorIf authorised for use in childrenIf authorised for use in children.
productClassificationAllows the product to be classified by various systemsAllows the product to be classified by various systems.
marketingStatusMarketing status of the medicinal product, in contrast to marketing authorizatonMarketing status of the medicinal product, in contrast to marketing authorizaton.
pharmaceuticalProductPharmaceutical aspects of productPharmaceutical aspects of product.
packagedMedicinalProductPackage representation for the productPackage representation for the product.
attachedDocumentSupporting documentation, typically for regulatory submissionSupporting documentation, typically for regulatory submission.
masterFileA master file for to the medicinal product (e.g. Pharmacovigilance System Master File)A master file for to the medicinal product (e.g. Pharmacovigilance System Master File).
contactA product specific contact, person (in a role), or an organizationA product specific contact, person (in a role), or an organization.
clinicalTrialClinical trials or studies that this product is involved inClinical trials or studies that this product is involved in.
nameThe product's name, including full name and possibly coded partsThe product's name, including full name and possibly coded parts.
name.idUnique id for inter-element referencingUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
name.extensionAdditional content defined by implementationsMay 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.
name.modifierExtensionExtensions that cannot be ignored even if unrecognizedMay 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.
name.productNameThe full product nameThe full product name.
name.namePartCoding words or phrases of the nameCoding words or phrases of the name.
name.namePart.idUnique id for inter-element referencingUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
name.namePart.extensionAdditional content defined by implementationsMay 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.
name.namePart.modifierExtensionExtensions that cannot be ignored even if unrecognizedMay 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.
name.namePart.partA fragment of a product nameA fragment of a product name.
name.namePart.typeIdenifying type for this part of the name (e.g. strength part)Idenifying type for this part of the name (e.g. strength part).
name.countryLanguageCountry where the name appliesCountry where the name applies.
name.countryLanguage.idUnique id for inter-element referencingUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
name.countryLanguage.extensionAdditional content defined by implementationsMay 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.
name.countryLanguage.modifierExtensionExtensions that cannot be ignored even if unrecognizedMay 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.
name.countryLanguage.countryCountry code for where this name appliesCountry code for where this name applies.
name.countryLanguage.jurisdictionJurisdiction code for where this name appliesJurisdiction code for where this name applies.
name.countryLanguage.languageLanguage code for this nameLanguage code for this name.
crossReferenceReference to another product, e.g. for linking authorised to investigational productReference to another product, e.g. for linking authorised to investigational product.
manufacturingBusinessOperationAn operation applied to the product, for manufacturing or adminsitrative purposeAn operation applied to the product, for manufacturing or adminsitrative purpose.
manufacturingBusinessOperation.idUnique id for inter-element referencingUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
manufacturingBusinessOperation.extensionAdditional content defined by implementationsMay 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.
manufacturingBusinessOperation.modifierExtensionExtensions that cannot be ignored even if unrecognizedMay 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.
manufacturingBusinessOperation.operationTypeThe type of manufacturing operationThe type of manufacturing operation.
manufacturingBusinessOperation.authorisationReferenceNumberRegulatory authorization reference numberRegulatory authorization reference number.
manufacturingBusinessOperation.effectiveDateRegulatory authorization dateRegulatory authorization date.
manufacturingBusinessOperation.confidentialityIndicatorTo indicate if this proces is commercially confidentialTo indicate if this proces is commercially confidential.
manufacturingBusinessOperation.manufacturerThe manufacturer or establishment associated with the processThe manufacturer or establishment associated with the process.
manufacturingBusinessOperation.regulatorA regulator which oversees the operationA regulator which oversees the operation.
specialDesignationIndicates if the medicinal product has an orphan designation for the treatment of a rare diseaseIndicates if the medicinal product has an orphan designation for the treatment of a rare disease.
specialDesignation.idUnique id for inter-element referencingUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
specialDesignation.extensionAdditional content defined by implementationsMay 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.
specialDesignation.modifierExtensionExtensions that cannot be ignored even if unrecognizedMay 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.
specialDesignation.identifierIdentifier for the designation, or procedure numberIdentifier for the designation, or procedure number.
specialDesignation.typeThe type of special designation, e.g. orphan drug, minor useThe type of special designation, e.g. orphan drug, minor use.
specialDesignation.intendedUseThe intended use of the product, e.g. prevention, treatmentThe intended use of the product, e.g. prevention, treatment.
specialDesignation.indication[x]Condition for which the medicinal use appliesCondition for which the medicinal use applies.
specialDesignation.statusFor example granted, pending, expired or withdrawnFor example granted, pending, expired or withdrawn.
specialDesignation.dateDate when the designation was grantedDate when the designation was granted.
specialDesignation.speciesAnimal species for which this appliesAnimal species for which this applies.


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]



Search Parameters

identifierBusiness identifier for this product. Could be an MPIDMedicinalProduct.identifier
nameThe full product nameMedicinalProduct.name.productName
name-languageLanguage code for this nameMedicinalProduct.name.countryLanguage.language

Extension Definitions

These are extension definitions for this resource defined by the spec