Path | Short | Definition | Comments |
---|---|---|---|
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). | ||
identifier | Business identifier for this product. Could be an MPID | Business identifier for this product. Could be an MPID. | |
type | Regulatory type, e.g. Investigational or Authorized | Regulatory type, e.g. Investigational or Authorized. | |
domain | If this medicine applies to human or veterinary uses | If this medicine applies to human or veterinary uses. | |
combinedPharmaceuticalDoseForm | The dose form for a single part product, or combined form of a multiple part product | The dose form for a single part product, or combined form of a multiple part product. | |
legalStatusOfSupply | The legal status of supply of the medicinal product as classified by the regulator | The legal status of supply of the medicinal product as classified by the regulator. | |
additionalMonitoringIndicator | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons. | |
specialMeasures | Whether the Medicinal Product is subject to special measures for regulatory reasons | Whether the Medicinal Product is subject to special measures for regulatory reasons. | |
paediatricUseIndicator | If authorised for use in children | If authorised for use in children. | |
productClassification | Allows the product to be classified by various systems | Allows the product to be classified by various systems. | |
marketingStatus | Marketing status of the medicinal product, in contrast to marketing authorizaton | Marketing status of the medicinal product, in contrast to marketing authorizaton. | |
pharmaceuticalProduct | Pharmaceutical aspects of product | Pharmaceutical aspects of product. | |
packagedMedicinalProduct | Package representation for the product | Package representation for the product. | |
attachedDocument | Supporting documentation, typically for regulatory submission | Supporting documentation, typically for regulatory submission. | |
masterFile | A 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). | |
contact | A product specific contact, person (in a role), or an organization | A product specific contact, person (in a role), or an organization. | |
clinicalTrial | Clinical trials or studies that this product is involved in | Clinical trials or studies that this product is involved in. | |
name | The product's name, including full name and possibly coded parts | The product's name, including full name and possibly coded parts. | |
name.id | Unique id for inter-element referencing | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | |
name.extension | Additional content defined by implementations | 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. |
name.modifierExtension | Extensions that cannot be ignored even if unrecognized | 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. |
name.productName | The full product name | The full product name. | |
name.namePart | Coding words or phrases of the name | Coding words or phrases of the name. | |
name.namePart.id | Unique id for inter-element referencing | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | |
name.namePart.extension | Additional content defined by implementations | 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. |
name.namePart.modifierExtension | Extensions that cannot be ignored even if unrecognized | 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. |
name.namePart.part | A fragment of a product name | A fragment of a product name. | |
name.namePart.type | Idenifying type for this part of the name (e.g. strength part) | Idenifying type for this part of the name (e.g. strength part). | |
name.countryLanguage | Country where the name applies | Country where the name applies. | |
name.countryLanguage.id | Unique id for inter-element referencing | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | |
name.countryLanguage.extension | Additional content defined by implementations | 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. |
name.countryLanguage.modifierExtension | Extensions that cannot be ignored even if unrecognized | 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. |
name.countryLanguage.country | Country code for where this name applies | Country code for where this name applies. | |
name.countryLanguage.jurisdiction | Jurisdiction code for where this name applies | Jurisdiction code for where this name applies. | |
name.countryLanguage.language | Language code for this name | Language code for this name. | |
crossReference | Reference to another product, e.g. for linking authorised to investigational product | Reference to another product, e.g. for linking authorised to investigational product. | |
manufacturingBusinessOperation | An operation applied to the product, for manufacturing or adminsitrative purpose | An operation applied to the product, for manufacturing or adminsitrative purpose. | |
manufacturingBusinessOperation.id | Unique id for inter-element referencing | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | |
manufacturingBusinessOperation.extension | Additional content defined by implementations | 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. |
manufacturingBusinessOperation.modifierExtension | Extensions that cannot be ignored even if unrecognized | 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. |
manufacturingBusinessOperation.operationType | The type of manufacturing operation | The type of manufacturing operation. | |
manufacturingBusinessOperation.authorisationReferenceNumber | Regulatory authorization reference number | Regulatory authorization reference number. | |
manufacturingBusinessOperation.effectiveDate | Regulatory authorization date | Regulatory authorization date. | |
manufacturingBusinessOperation.confidentialityIndicator | To indicate if this proces is commercially confidential | To indicate if this proces is commercially confidential. | |
manufacturingBusinessOperation.manufacturer | The manufacturer or establishment associated with the process | The manufacturer or establishment associated with the process. | |
manufacturingBusinessOperation.regulator | A regulator which oversees the operation | A regulator which oversees the operation. | |
specialDesignation | Indicates if the medicinal product has an orphan designation for the treatment of a rare disease | Indicates if the medicinal product has an orphan designation for the treatment of a rare disease. | |
specialDesignation.id | Unique id for inter-element referencing | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | |
specialDesignation.extension | Additional content defined by implementations | 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. |
specialDesignation.modifierExtension | Extensions that cannot be ignored even if unrecognized | 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. |
specialDesignation.identifier | Identifier for the designation, or procedure number | Identifier for the designation, or procedure number. | |
specialDesignation.type | The type of special designation, e.g. orphan drug, minor use | The type of special designation, e.g. orphan drug, minor use. | |
specialDesignation.intendedUse | The intended use of the product, e.g. prevention, treatment | The intended use of the product, e.g. prevention, treatment. | |
specialDesignation.indication[x] | Condition for which the medicinal use applies | Condition for which the medicinal use applies. | |
specialDesignation.status | For example granted, pending, expired or withdrawn | For example granted, pending, expired or withdrawn. | |
specialDesignation.date | Date when the designation was granted | Date when the designation was granted. | |
specialDesignation.species | Animal species for which this applies | Animal species for which this applies. |
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]
identifier | Business identifier for this product. Could be an MPID | MedicinalProduct.identifier |
name | The full product name | MedicinalProduct.name.productName |
name-language | Language code for this name | MedicinalProduct.name.countryLanguage.language |