R4 Ballot #1 (Mixed Normative/Trial use)
MedicationsThis page is part of the FHIR Specification (v3.3.0: R4 Ballot 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 
| Biomedical Research and Regulation Work Group | Maturity Level: 0 | Draft | Compartments: Not linked to any defined compartments |
Detailed Descriptions for the elements in the MedicinalProductAuthorization resource.
| MedicinalProductAuthorization | |
| Element Id | MedicinalProductAuthorization |
| Definition | The regulatory authorization of a medicinal product. |
| Control | 1..1 |
| Summary | true |
| MedicinalProductAuthorization.identifier | |
| Element Id | MedicinalProductAuthorization.identifier |
| Definition | Business identifier for the marketing authorization, as assigned by a regulator. |
| Note | This is a business identifer, not a resource identifier (see discussion) |
| Control | 0..1 |
| Type | Identifier |
| Summary | true |
| MedicinalProductAuthorization.country | |
| Element Id | MedicinalProductAuthorization.country |
| Definition | The country in which the marketing authorization has been granted. |
| Control | 1..* |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProductAuthorization.legalStatusOfSupply | |
| Element Id | MedicinalProductAuthorization.legalStatusOfSupply |
| Definition | The legal status of supply of the medicinal product as classified by the regulator. |
| Control | 1..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProductAuthorization.status | |
| Element Id | MedicinalProductAuthorization.status |
| Definition | The status of the marketing authorization. |
| Control | 1..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProductAuthorization.statusDate | |
| Element Id | MedicinalProductAuthorization.statusDate |
| Definition | The date at which the given status has become applicable. |
| Control | 1..1 |
| Type | dateTime |
| Summary | true |
| MedicinalProductAuthorization.restoreDate | |
| Element Id | MedicinalProductAuthorization.restoreDate |
| Definition | The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored. |
| Control | 0..1 |
| Type | dateTime |
| Summary | true |
| MedicinalProductAuthorization.validityPeriod | |
| Element Id | MedicinalProductAuthorization.validityPeriod |
| Definition | The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. |
| Control | 1..1 |
| Type | Period |
| Summary | true |
| MedicinalProductAuthorization.dataExclusivityPeriod | |
| Element Id | MedicinalProductAuthorization.dataExclusivityPeriod |
| Definition | A period of time after authorization before generic product applicatiosn can be submitted. |
| Control | 0..1 |
| Type | Period |
| Summary | true |
| MedicinalProductAuthorization.dateOfFirstAuthorization | |
| Element Id | MedicinalProductAuthorization.dateOfFirstAuthorization |
| Definition | The date when the first authorization was granted by a Medicines Regulatory Agency. |
| Control | 0..1 |
| Type | dateTime |
| Summary | true |
| MedicinalProductAuthorization.internationalBirthDate | |
| Element Id | MedicinalProductAuthorization.internationalBirthDate |
| Definition | Date of first marketing authorization for a company's new medicinal product in any country in the World. |
| Control | 1..1 |
| Type | dateTime |
| Summary | true |
| MedicinalProductAuthorization.jurisdictionalAuthorization | |
| Element Id | MedicinalProductAuthorization.jurisdictionalAuthorization |
| Definition | Authorization in areas within a country. |
| Control | 0..* |
| Summary | true |
| MedicinalProductAuthorization.jurisdictionalAuthorization.country | |
| Element Id | MedicinalProductAuthorization.jurisdictionalAuthorization.country |
| Definition | Country of authorization. |
| Control | 1..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction | |
| Element Id | MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction |
| Definition | Jurisdiction within a country. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProductAuthorization.jurisdictionalAuthorization.number | |
| Element Id | MedicinalProductAuthorization.jurisdictionalAuthorization.number |
| Definition | The assigned number for the marketing authorization. |
| Control | 0..1 |
| Type | Identifier |
| Summary | true |
| MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply | |
| Element Id | MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply |
| Definition | The legal status of supply in a jurisdiction or region. |
| Control | 0..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProductAuthorization.holder | |
| Element Id | MedicinalProductAuthorization.holder |
| Definition | Marketing Authorization Holder. |
| Control | 1..1 |
| Type | Reference(Organization) |
| Summary | true |
| MedicinalProductAuthorization.regulator | |
| Element Id | MedicinalProductAuthorization.regulator |
| Definition | Medicines Regulatory Agency. |
| Control | 1..1 |
| Type | Reference(Organization) |
| Summary | true |
| MedicinalProductAuthorization.procedure | |
| Element Id | MedicinalProductAuthorization.procedure |
| Definition | The regulatory procedure for granting or amending a marketing authorization. |
| Control | 1..1 |
| Summary | true |
| MedicinalProductAuthorization.procedure.number | |
| Element Id | MedicinalProductAuthorization.procedure.number |
| Definition | Identifier for this procedure. |
| Control | 0..1 |
| Type | Identifier |
| Summary | true |
| MedicinalProductAuthorization.procedure.type | |
| Element Id | MedicinalProductAuthorization.procedure.type |
| Definition | Type of procedure. |
| Control | 1..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProductAuthorization.procedure.date | |
| Element Id | MedicinalProductAuthorization.procedure.date |
| Definition | Date of procedure. |
| Control | 0..1 |
| Type | Period |
| Summary | true |
| MedicinalProductAuthorization.procedure.application | |
| Element Id | MedicinalProductAuthorization.procedure.application |
| Definition | Applcations submitted to obtain a marketing authorization. |
| Control | 0..* |
| Summary | true |
| MedicinalProductAuthorization.procedure.application.number | |
| Element Id | MedicinalProductAuthorization.procedure.application.number |
| Definition | A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. |
| Control | 1..1 |
| Type | Identifier |
| Summary | true |
| MedicinalProductAuthorization.procedure.application.type | |
| Element Id | MedicinalProductAuthorization.procedure.application.type |
| Definition | The type of the application. |
| Control | 1..1 |
| Type | CodeableConcept |
| Summary | true |
| MedicinalProductAuthorization.procedure.application.date | |
| Element Id | MedicinalProductAuthorization.procedure.application.date |
| Definition | Date that the application was made. |
| Control | 1..1 |
| Type | dateTime |
| Summary | true |
| MedicinalProductAuthorization.marketingStatus | |
| Element Id | MedicinalProductAuthorization.marketingStatus |
| Definition | Marketing status of the medicinal product, in contrast to marketing authorizaton. |
| Control | 0..* |
| Type | MarketingStatus |
| Summary | true |
®© HL7.org 2011+. FHIR Mixed Nomative/Trial Use Ballot (v3.3.0-13671) generated on Tue, Apr 3, 2018 12:16+1000. QA Page
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