MedicinalProductAuthorization
SpecializedThe regulatory authorization of a medicinal product.
| Path | Card. | Type | Description & Constraints |
|---|---|---|---|
| MedicinalProductAuthorization | 0..* | — | The regulatory authorization of a medicinal product |
| .idΣ | 0..1 | String | Logical id of this artifact |
| .metaΣ | 0..1 | Meta | Metadata about the resource |
| .implicitRules?!Σ | 0..1 | uri | A set of rules under which this content was created |
| .language | 0..1 | code | Language of the resource content Bindinglanguages(preferred) |
| .text | 0..1 | Narrative | Text summary of the resource, for human interpretation |
| .contained | 0..* | Resource | Contained, inline Resources |
| .extension | 0..* | Extension | Additional content defined by implementations |
| .modifierExtension?! | 0..* | Extension | Extensions that cannot be ignored |
| .identifierΣ | 0..* | Identifier | Business identifier for the marketing authorization, as assigned by a regulator |
| .subjectΣ | 0..1 | Reference(MedicinalProduct | MedicinalProductPackaged) | The medicinal product that is being authorized |
| .countryΣ | 0..* | CodeableConcept | The country in which the marketing authorization has been granted |
| .jurisdictionΣ | 0..* | CodeableConcept | Jurisdiction within a country |
| .statusΣ | 0..1 | CodeableConcept | The status of the marketing authorization |
| .statusDateΣ | 0..1 | dateTime | The date at which the given status has become applicable |
| .restoreDateΣ | 0..1 | dateTime | The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored |
| .validityPeriodΣ | 0..1 | Period | 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 |
| .dataExclusivityPeriodΣ | 0..1 | Period | A period of time after authorization before generic product applicatiosn can be submitted |
| .dateOfFirstAuthorizationΣ | 0..1 | dateTime | The date when the first authorization was granted by a Medicines Regulatory Agency |
| .internationalBirthDateΣ | 0..1 | dateTime | Date of first marketing authorization for a company's new medicinal product in any country in the World |
| .legalBasisΣ | 0..1 | CodeableConcept | The legal framework against which this authorization is granted |
| .jurisdictionalAuthorizationΣ | 0..* | BackboneElement | Authorization in areas within a country |
| .id | 0..1 | String | Unique id for inter-element referencing |
| .extension | 0..* | Extension | Additional content defined by implementations |
| .modifierExtension?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| .identifierΣ | 0..* | Identifier | The assigned number for the marketing authorization |
| .countryΣ | 0..1 | CodeableConcept | Country of authorization |
| .jurisdictionΣ | 0..* | CodeableConcept | Jurisdiction within a country |
| .legalStatusOfSupplyΣ | 0..1 | CodeableConcept | The legal status of supply in a jurisdiction or region |
| .validityPeriodΣ | 0..1 | Period | The start and expected end date of the authorization |
| .holderΣ | 0..1 | Reference(Organization) | Marketing Authorization Holder |
| .regulatorΣ | 0..1 | Reference(Organization) | Medicines Regulatory Agency |
| .procedureΣ | 0..1 | BackboneElement | The regulatory procedure for granting or amending a marketing authorization |
| .id | 0..1 | String | Unique id for inter-element referencing |
| .extension | 0..* | Extension | Additional content defined by implementations |
| .modifierExtension?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| .identifierΣ | 0..1 | Identifier | Identifier for this procedure |
| .typeΣ | 1..1 | CodeableConcept | Type of procedure |
| .date[x]Σ | 0..1 | Period | dateTime | Date of procedure |
| .applicationΣ | 0..* | — | Applcations submitted to obtain a marketing authorization |