Path | Short | Definition | Comments |
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| The regulatory authorization of a medicinal product | The regulatory authorization of a medicinal product. | |
identifier | Business identifier for the marketing authorization, as assigned by a regulator | Business identifier for the marketing authorization, as assigned by a regulator. | |
subject | The medicinal product that is being authorized | The medicinal product that is being authorized. | |
country | The country in which the marketing authorization has been granted | The country in which the marketing authorization has been granted. | |
jurisdiction | Jurisdiction within a country | Jurisdiction within a country. | |
status | The status of the marketing authorization | The status of the marketing authorization. | |
statusDate | The date at which the given status has become applicable | The date at which the given status has become applicable. | |
restoreDate | The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored | The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored. | |
validityPeriod | 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 | 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. | |
dataExclusivityPeriod | A period of time after authorization before generic product applicatiosn can be submitted | A period of time after authorization before generic product applicatiosn can be submitted. | |
dateOfFirstAuthorization | The date when the first authorization was granted by a Medicines Regulatory Agency | The date when the first authorization was granted by a Medicines Regulatory Agency. | |
internationalBirthDate | Date of first marketing authorization for a company's new medicinal product in any country in the World | Date of first marketing authorization for a company's new medicinal product in any country in the World. | |
legalBasis | The legal framework against which this authorization is granted | The legal framework against which this authorization is granted. | |
jurisdictionalAuthorization | Authorization in areas within a country | Authorization in areas within a country. | |
jurisdictionalAuthorization.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. | |
jurisdictionalAuthorization.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. |
jurisdictionalAuthorization.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. |
jurisdictionalAuthorization.identifier | The assigned number for the marketing authorization | The assigned number for the marketing authorization. | |
jurisdictionalAuthorization.country | Country of authorization | Country of authorization. | |
jurisdictionalAuthorization.jurisdiction | Jurisdiction within a country | Jurisdiction within a country. | |
jurisdictionalAuthorization.legalStatusOfSupply | The legal status of supply in a jurisdiction or region | The legal status of supply in a jurisdiction or region. | |
jurisdictionalAuthorization.validityPeriod | The start and expected end date of the authorization | The start and expected end date of the authorization. | |
holder | Marketing Authorization Holder | Marketing Authorization Holder. | |
regulator | Medicines Regulatory Agency | Medicines Regulatory Agency. | |
procedure | The regulatory procedure for granting or amending a marketing authorization | The regulatory procedure for granting or amending a marketing authorization. | |
procedure.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. | |
procedure.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. |
procedure.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. |
procedure.identifier | Identifier for this procedure | Identifier for this procedure. | |
procedure.type | Type of procedure | Type of procedure. | |
procedure.date[x] | Date of procedure | Date of procedure. | |
procedure.application | Applcations submitted to obtain a marketing authorization | Applcations submitted to obtain a marketing authorization. | |