| identifier | No | Identifier[] | Business identifier for this product. Could be an MPID |
| type | No | CodeableConcept | Regulatory type, e.g. Investigational or Authorized |
| domain | No | Coding | If this medicine applies to human or veterinary uses |
| combinedPharmaceuticalDoseForm | No | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product |
| legalStatusOfSupply | No | CodeableConcept | The legal status of supply of the medicinal product as classified by the regulator |
| additionalMonitoringIndicator | No | CodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons |
| specialMeasures | No | string[] | Whether the Medicinal Product is subject to special measures for regulatory reasons |
| paediatricUseIndicator | No | CodeableConcept | If authorised for use in children |
| productClassification | No | CodeableConcept[] | Allows the product to be classified by various systems |
| marketingStatus | No | MarketingStatus[] | Marketing status of the medicinal product, in contrast to marketing authorizaton |
| pharmaceuticalProduct | No | Reference<MedicinalProductPharmaceutical>[] | Pharmaceutical aspects of product |
| packagedMedicinalProduct | No | Reference<MedicinalProductPackaged>[] | Package representation for the product |
| attachedDocument | No | Reference<DocumentReference>[] | Supporting documentation, typically for regulatory submission |
| masterFile | No | Reference<DocumentReference>[] | A master file for to the medicinal product (e.g. Pharmacovigilance System Master File) |
| contact | No | Reference<Organization / PractitionerRole>[] | A product specific contact, person (in a role), or an organization |
| clinicalTrial | No | Reference<ResearchStudy>[] | Clinical trials or studies that this product is involved in |
| name | Yes | MedicinalProductName | The product’s name, including full name and possibly coded parts |
| - id | No | string | Unique id for inter-element referencing |
| - extension | No | Extension[] | Additional content defined by implementations |
| - modifierExtension | No | Extension[] | Extensions that cannot be ignored even if unrecognized |
| - productName | Yes | string | The full product name |
| - namePart | No | MedicinalProductNameNamePart | Coding words or phrases of the name |
| - id | No | string | Unique id for inter-element referencing |
| - extension | No | Extension[] | Additional content defined by implementations |
| - modifierExtension | No | Extension[] | Extensions that cannot be ignored even if unrecognized |
| - part | Yes | string | A fragment of a product name |
| - type | Yes | Coding | Idenifying type for this part of the name (e.g. strength part) |
| - countryLanguage | No | MedicinalProductNameCountryLanguage | Country where the name applies |
| - id | No | string | Unique id for inter-element referencing |
| - extension | No | Extension[] | Additional content defined by implementations |
| - modifierExtension | No | Extension[] | Extensions that cannot be ignored even if unrecognized |
| - country | Yes | CodeableConcept | Country code for where this name applies |
| - jurisdiction | No | CodeableConcept | Jurisdiction code for where this name applies |
| - language | Yes | CodeableConcept | Language code for this name |
| crossReference | No | Identifier[] | Reference to another product, e.g. for linking authorised to investigational product |
| manufacturingBusinessOperation | No | MedicinalProductManufacturingBusinessOperation | An operation applied to the product, for manufacturing or adminsitrative purpose |
| - id | No | string | Unique id for inter-element referencing |
| - extension | No | Extension[] | Additional content defined by implementations |
| - modifierExtension | No | Extension[] | Extensions that cannot be ignored even if unrecognized |
| - operationType | No | CodeableConcept | The type of manufacturing operation |
| - authorisationReferenceNumber | No | Identifier | Regulatory authorization reference number |
| - effectiveDate | No | dateTime | Regulatory authorization date |
| - confidentialityIndicator | No | CodeableConcept | To indicate if this proces is commercially confidential |
| - manufacturer | No | Reference<Organization>[] | The manufacturer or establishment associated with the process |
| - regulator | No | Reference<Organization> | A regulator which oversees the operation |
| specialDesignation | No | MedicinalProductSpecialDesignation | Indicates if the medicinal product has an orphan designation for the treatment of a rare disease |
| - id | No | string | Unique id for inter-element referencing |
| - extension | No | Extension[] | Additional content defined by implementations |
| - modifierExtension | No | Extension[] | Extensions that cannot be ignored even if unrecognized |
| - identifier | No | Identifier[] | Identifier for the designation, or procedure number |
| - type | No | CodeableConcept | The type of special designation, e.g. orphan drug, minor use |
| - intendedUse | No | CodeableConcept | The intended use of the product, e.g. prevention, treatment |
| - indication[x] | No | CodeableConcept, Reference<MedicinalProductIndication> | Condition for which the medicinal use applies |
| - status | No | CodeableConcept | For example granted, pending, expired or withdrawn |
| - date | No | dateTime | Date when the designation was granted |
| - species | No | CodeableConcept | Animal species for which this applies |
