regulated-authorization-type (RegulatedAuthorizationType) referenced by ValueSet regulated-authorization-type bound to element RegulatedAuthorization.type is never bound to a code-type element. Should it move to THO?product-intended-use (ProductIntendedUse) referenced by ValueSet product-intended-use bound to element RegulatedAuthorization.intendedUse is never bound to a code-type element. Should it move to THO?regulated-authorization-basis (RegulatedAuthorizationBasis) referenced by ValueSet regulated-authorization-basis bound to element RegulatedAuthorization.basis is never bound to a code-type element. Should it move to THO?regulated-authorization-case-type (RegulatedAuthorizationCaseType) referenced by ValueSet regulated-authorization-case-type bound to element RegulatedAuthorization.case.type is never bound to a code-type element. Should it move to THO?| Page File Name | regulatedauthorization-introduction.xml |
| Responsible Workgroup | brr |
| Maturity Label | Active |
| Maturity Level | 2 |
| Standards Status | normative |
| Management Comments | |
| Workgroup Comments | |
Exists In publish.ini |
No |
| Exists In Source Directory | Yes |
'deprecated' Literal Count |
0 |
| Zulip Link Count | 0 |
| Confluence Link Count | 0 |
'Conformant' conformance language appears in all-upper case. 'Non-conformant' covers all other cases appearing in the content.
| Literal | Conformant | Non-Conformant |
|---|---|---|
| SHALL | 0 | 0 |
| SHALL NOT | 0 | 0 |
| SHOULD | 0 | 0 |
| SHOULD NOT | 0 | 0 |
| MAY | 0 | 0 |
| MAY NOT | 0 | 0 |
| Word | Artifact Class |
|---|
| Word | Known Typo |
|---|
| Source | Missing Alt Text | Not In Figure Tag |
|---|
| Page File Name | regulatedauthorization-notes.xml |
| Responsible Workgroup | brr |
| Maturity Label | Active |
| Maturity Level | 2 |
| Standards Status | normative |
| Management Comments | |
| Workgroup Comments | |
Exists In publish.ini |
No |
| Exists In Source Directory | Yes |
'deprecated' Literal Count |
0 |
| Zulip Link Count | 0 |
| Confluence Link Count | 0 |
'Conformant' conformance language appears in all-upper case. 'Non-conformant' covers all other cases appearing in the content.
| Literal | Conformant | Non-Conformant |
|---|---|---|
| SHALL | 0 | 0 |
| SHALL NOT | 0 | 0 |
| SHOULD | 0 | 0 |
| SHOULD NOT | 0 | 0 |
| MAY | 0 | 0 |
| MAY NOT | 0 | 0 |
| Word | Artifact Class |
|---|
| Word | Known Typo |
|---|
| Source | Missing Alt Text | Not In Figure Tag |
|---|
| Path | Is Required | Max Cardinality | Trial Use | Has fixed[x] | Has pattern[x] | Required Binding | External Required Binding | Check meaningWhenMissing |
Is Modifier |
|---|---|---|---|---|---|---|---|---|---|
RegulatedAuthorization |
* |
|
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RegulatedAuthorization.identifier |
* |
|
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RegulatedAuthorization.subject |
* |
|
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RegulatedAuthorization.type |
1 |
|
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RegulatedAuthorization.description |
1 |
|
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RegulatedAuthorization.region |
* |
|
|||||||
RegulatedAuthorization.status |
1 |
|
X | ||||||
RegulatedAuthorization.statusDate |
1 |
|
|||||||
RegulatedAuthorization.validityPeriod |
1 |
|
|||||||
RegulatedAuthorization.indication |
* |
|
|||||||
RegulatedAuthorization.intendedUse |
1 |
|
|||||||
RegulatedAuthorization.basis |
* |
|
|||||||
RegulatedAuthorization.holder |
1 |
|
|||||||
RegulatedAuthorization.regulator |
1 |
|
|||||||
RegulatedAuthorization.attachedDocument |
* |
|
|||||||
RegulatedAuthorization.case |
1 |
|
|||||||
RegulatedAuthorization.case.identifier |
1 |
|
|||||||
RegulatedAuthorization.case.type |
1 |
|
|||||||
RegulatedAuthorization.case.status |
1 |
|
|||||||
RegulatedAuthorization.case.date[x] |
1 |
|
|||||||
RegulatedAuthorization.case.application |
* |
|
No operations found.
| Id | Name | Publication Status | FMM | Standards Status | IsExperimental | WorkGroup | Search Type | Description |
|---|---|---|---|---|---|---|---|---|
RegulatedAuthorization-case |
case |
Active | normative | False | brr | token | The case or procedure number | |
RegulatedAuthorization-case-type |
case-type |
Active | normative | False | brr | token | The defining type of case | |
RegulatedAuthorization-holder |
holder |
Active | normative | False | brr | reference | The organization that holds the granted authorization | |
RegulatedAuthorization-identifier |
identifier |
Active | normative | False | brr | token | Business identifier for the authorization, typically assigned by the authorizing body | |
RegulatedAuthorization-region |
region |
Active | normative | False | brr | token | The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted | |
RegulatedAuthorization-status |
status |
Active | normative | False | brr | token | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications | |
RegulatedAuthorization-subject |
subject |
Active | normative | False | brr | reference | The type of regulated product, treatment, facility or activity that is being authorized | |
RegulatedAuthorization-type |
type |
Active | normative | False | brr | token | Overall type of this authorization, for example drug marketing approval, orphan drug designation | |
RegulatedAuthorization-validity |
validity |
Active | normative | False | brr | date | The time period in which the regulatory approval, clearance or licensing is in effect |