This page is part of the FHIR Specification (v4.4.0: R5 Preview #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B
Biomedical Research and Regulation Work Group | Maturity Level: 1 | Trial Use | Security Category: Anonymous | Compartments: Not linked to any defined compartments |
Detailed Descriptions for the elements in the MedicinalProductDefinition resource.
MedicinalProductDefinition | |
Element Id | MedicinalProductDefinition |
Definition | Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use). |
Cardinality | 0..* |
Type | DomainResource |
Summary | true |
MedicinalProductDefinition.identifier | |
Element Id | MedicinalProductDefinition.identifier |
Definition | Business identifier for this product. Could be an MPID. |
Note | This is a business identifier, not a resource identifier (see discussion) |
Cardinality | 0..* |
Type | Identifier |
Alternate Names | MPID |
Summary | true |
MedicinalProductDefinition.type | |
Element Id | MedicinalProductDefinition.type |
Definition | Regulatory type, e.g. Investigational or Authorized. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProductDefinition.domain | |
Element Id | MedicinalProductDefinition.domain |
Definition | If this medicine applies to human or veterinary uses. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProductDefinition.version | |
Element Id | MedicinalProductDefinition.version |
Definition | A business level identifier of the product. |
Note | This is a business versionId, not a resource version id (see discussion) |
Cardinality | 0..1 |
Type | string |
Summary | true |
MedicinalProductDefinition.status | |
Element Id | MedicinalProductDefinition.status |
Definition | The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization status. |
Cardinality | 0..1 |
Terminology Binding | PublicationStatus (Preferred) |
Type | CodeableConcept |
Summary | true |
MedicinalProductDefinition.statusDate | |
Element Id | MedicinalProductDefinition.statusDate |
Definition | The date at which the given status became applicable. |
Cardinality | 0..1 |
Type | dateTime |
Summary | true |
MedicinalProductDefinition.description | |
Element Id | MedicinalProductDefinition.description |
Definition | General description of this product. |
Cardinality | 0..1 |
Type | markdown |
Summary | true |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | |
Element Id | MedicinalProductDefinition.combinedPharmaceuticalDoseForm |
Definition | The dose form for a single part product, or combined form of a multiple part product. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProductDefinition.indication | |
Element Id | MedicinalProductDefinition.indication |
Definition | General combined description of indication(s) for this product. See also MedicinalProductDefinitionIndication. |
Cardinality | 0..1 |
Type | markdown |
Summary | true |
MedicinalProductDefinition.legalStatusOfSupply | |
Element Id | MedicinalProductDefinition.legalStatusOfSupply |
Definition | The legal status of supply of the medicinal product as classified by the regulator. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProductDefinition.additionalMonitoringIndicator | |
Element Id | MedicinalProductDefinition.additionalMonitoringIndicator |
Definition | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProductDefinition.specialMeasures | |
Element Id | MedicinalProductDefinition.specialMeasures |
Definition | Whether the Medicinal Product is subject to special measures for regulatory reasons. |
Cardinality | 0..* |
Type | CodeableConcept |
Summary | true |
MedicinalProductDefinition.paediatricUseIndicator | |
Element Id | MedicinalProductDefinition.paediatricUseIndicator |
Definition | If authorised for use in children. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProductDefinition.productClassification | |
Element Id | MedicinalProductDefinition.productClassification |
Definition | Allows the product to be classified by various systems. |
Cardinality | 0..* |
Type | CodeableConcept |
Summary | true |
MedicinalProductDefinition.characteristic | |
Element Id | MedicinalProductDefinition.characteristic |
Definition | Allows the key product features to be recorded, such as "suger free", "modified release", "parallel import". |
Cardinality | 0..* |
Type | CodeableConcept |
Summary | true |
MedicinalProductDefinition.marketingStatus | |
Element Id | MedicinalProductDefinition.marketingStatus |
Definition | Marketing status of the medicinal product, in contrast to marketing authorizaton. |
Cardinality | 0..* |
Type | MarketingStatus |
Summary | true |
MedicinalProductDefinition.pharmaceuticalProduct | |
Element Id | MedicinalProductDefinition.pharmaceuticalProduct |
Definition | Pharmaceutical aspects of product. |
Cardinality | 0..* |
Type | Reference(AdministrableProductDefinition) |
Summary | true |
MedicinalProductDefinition.packagedMedicinalProduct | |
Element Id | MedicinalProductDefinition.packagedMedicinalProduct |
Definition | Package representation for the product. |
Cardinality | 0..* |
Type | Reference(PackagedProductDefinition) |
Summary | true |
MedicinalProductDefinition.ingredient | |
Element Id | MedicinalProductDefinition.ingredient |
Definition | The ingredients of this medicinal product - when not specified elsewhere. This is only needed if the ingredients are not specified by the pharmaceuticalProduct or packagedMedicinalProduct references above. In cases where those levels of detail are not used, the ingredients may be specified directly here. |
Cardinality | 0..* |
Type | Reference(Ingredient) |
Summary | true |
MedicinalProductDefinition.attachedDocument | |
Element Id | MedicinalProductDefinition.attachedDocument |
Definition | Supporting documentation, typically for regulatory submission. |
Cardinality | 0..* |
Type | Reference(DocumentReference) |
Summary | true |
MedicinalProductDefinition.masterFile | |
Element Id | MedicinalProductDefinition.masterFile |
Definition | A master file for to the medicinal product (e.g. Pharmacovigilance System Master File). |
Cardinality | 0..* |
Type | Reference(DocumentReference) |
Summary | true |
MedicinalProductDefinition.contact | |
Element Id | MedicinalProductDefinition.contact |
Definition | A product specific contact, person (in a role), or an organization. |
Cardinality | 0..* |
Summary | true |
MedicinalProductDefinition.contact.type | |
Element Id | MedicinalProductDefinition.contact.type |
Definition | Allows the contact to be classified, for example QPPV, Pharmacovigilence Enquiry Information. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProductDefinition.contact.contact | |
Element Id | MedicinalProductDefinition.contact.contact |
Definition | A product specific contact, person (in a role), or an organization. |
Cardinality | 1..1 |
Type | Reference(Organization | PractitionerRole) |
Patterns | Reference(Organization,PractitionerRole): Common patterns = Participant |
Summary | true |
MedicinalProductDefinition.clinicalTrial | |
Element Id | MedicinalProductDefinition.clinicalTrial |
Definition | Clinical trials or studies that this product is involved in. |
Cardinality | 0..* |
Type | Reference(ResearchStudy) |
Summary | true |
MedicinalProductDefinition.name | |
Element Id | MedicinalProductDefinition.name |
Definition | The product's name, including full name and possibly coded parts. |
Cardinality | 1..* |
Summary | true |
MedicinalProductDefinition.name.productName | |
Element Id | MedicinalProductDefinition.name.productName |
Definition | The full product name. |
Cardinality | 1..1 |
Type | string |
Summary | true |
MedicinalProductDefinition.name.type | |
Element Id | MedicinalProductDefinition.name.type |
Definition | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProductDefinition.name.namePart | |
Element Id | MedicinalProductDefinition.name.namePart |
Definition | Coding words or phrases of the name. |
Cardinality | 0..* |
Summary | true |
MedicinalProductDefinition.name.namePart.part | |
Element Id | MedicinalProductDefinition.name.namePart.part |
Definition | A fragment of a product name. |
Cardinality | 1..1 |
Type | string |
Summary | true |
MedicinalProductDefinition.name.namePart.type | |
Element Id | MedicinalProductDefinition.name.namePart.type |
Definition | Idenifying type for this part of the name (e.g. strength part). |
Cardinality | 1..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProductDefinition.name.countryLanguage | |
Element Id | MedicinalProductDefinition.name.countryLanguage |
Definition | Country where the name applies. |
Cardinality | 0..* |
Summary | true |
MedicinalProductDefinition.name.countryLanguage.country | |
Element Id | MedicinalProductDefinition.name.countryLanguage.country |
Definition | Country code for where this name applies. |
Cardinality | 1..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProductDefinition.name.countryLanguage.jurisdiction | |
Element Id | MedicinalProductDefinition.name.countryLanguage.jurisdiction |
Definition | Jurisdiction code for where this name applies. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProductDefinition.name.countryLanguage.language | |
Element Id | MedicinalProductDefinition.name.countryLanguage.language |
Definition | Language code for this name. |
Cardinality | 1..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProductDefinition.crossReference | |
Element Id | MedicinalProductDefinition.crossReference |
Definition | Reference to another product, e.g. for linking authorised to investigational product. |
Cardinality | 0..* |
Summary | true |
MedicinalProductDefinition.crossReference.product[x] | |
Element Id | MedicinalProductDefinition.crossReference.product[x] |
Definition | Reference to another product, e.g. for linking authorised to investigational product. |
Cardinality | 1..1 |
Type | Identifier|Reference(MedicinalProductDefinition) |
[x] Note | See Choice of Data Types for further information about how to use [x] |
Summary | true |
MedicinalProductDefinition.crossReference.type | |
Element Id | MedicinalProductDefinition.crossReference.type |
Definition | The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
MedicinalProductDefinition.manufacturingBusinessOperation | |
Element Id | MedicinalProductDefinition.manufacturingBusinessOperation |
Definition | An operation applied to the product, for manufacturing or adminsitrative purpose. |
Cardinality | 0..* |
Summary | true |
MedicinalProductDefinition.manufacturingBusinessOperation.type | |
Element Id | MedicinalProductDefinition.manufacturingBusinessOperation.type |
Definition | The type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute. |
Cardinality | 0..1 |
Type | CodeableReference(ActivityDefinition) |
Summary | true |
MedicinalProductDefinition.manufacturingBusinessOperation.effectiveDate | |
Element Id | MedicinalProductDefinition.manufacturingBusinessOperation.effectiveDate |
Definition | Date range of applicability. |
Cardinality | 0..1 |
Type | Period |
Summary | true |
MedicinalProductDefinition.manufacturingBusinessOperation.manufacturer | |
Element Id | MedicinalProductDefinition.manufacturingBusinessOperation.manufacturer |
Definition | The manufacturer or establishment associated with the process. |
Cardinality | 0..* |
Type | Reference(Organization) |
Summary | true |
MedicinalProductDefinition.manufacturingBusinessOperation.authorization | |
Element Id | MedicinalProductDefinition.manufacturingBusinessOperation.authorization |
Definition | An authorization for this process, either as a logical reference, holding just an identifier, or a full refererence to a resource that captures the details. The authorization mayu possibly apply to several products or a wider scope of process of which this is a part. |
Cardinality | 0..1 |
Type | Reference(RegulatedAuthorization) |
Summary | true |
MedicinalProductDefinition.manufacturingBusinessOperation.confidentialityIndicator | |
Element Id | MedicinalProductDefinition.manufacturingBusinessOperation.confidentialityIndicator |
Definition | To indicate if this proces is commercially confidential. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |