SMART Product Catalog, published by WHO. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/WorldHealthOrganization/smart-pcmt/tree/main and changes regularly. See the Directory of published versions
Logical Model: Product Authorization
| Official URL: http://smart.who.int/pcmt/StructureDefinition/ProductAuthorization | Version: 0.1.0 | |||
| Draft as of 2025-03-06 | Computable Name: ProductAuthorization | |||
A record of authorization or compliance for one or more Products with a set of regulatory, policy, (pre-)qualification, or legal requirements.
Usage:
- This Logical Model Profile is not used by any profiles in this Implementation Guide
Formal Views of Profile Content
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  ProductAuthorization |
0..* | Base | Product Authorization Instances of this logical model can be the target of a Reference | |
  number |
0..1 | Identifier | The identifier of the authorisation for the Products | |
 status |
1..1 | code | Product status Binding: Status for a Product (extensible) | |
| type |
1..1 | code | Regulation type Binding: Regulation Type for a Regulated Product (extensible) | |
| jurisdiction |
1..* | CodeableConcept | The jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued | |
 holder |
1..1 | Reference(mCSD Organization) | The organisation responsible for the product i.e. the grantee of the authorisation | |
| product |
1..* | Reference(Product) | Products that are covered under this authorization | |
 validityPeriod |
0..1 | Period | Validity Period of this authorization | |
| Documentation for this format | ||||
Terminology Bindings
| Path | Conformance | ValueSet | URI |
| ProductAuthorization.status | extensible | Status (a valid code from Product and regulatory authorization status)http://smart.who.int/pcmt/ValueSet/Statusfrom this IG | |
| ProductAuthorization.type | extensible | RegulationType (a valid code from http://smart.who.int/pcmt/CodeSystem/RegulationType)http://smart.who.int/pcmt/ValueSet/RegulationTypefrom this IG |
This structure is derived from Base
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ProductAuthorization |
0..* | Base | Product Authorization Instances of this logical model can be the target of a Reference | |
| number |
0..1 | Identifier | The identifier of the authorisation for the Products | |
| status |
1..1 | code | Product status Binding: Status for a Product (extensible) | |
| type |
1..1 | code | Regulation type Binding: Regulation Type for a Regulated Product (extensible) | |
| jurisdiction |
1..* | CodeableConcept | The jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued | |
| holder |
1..1 | Reference(mCSD Organization) | The organisation responsible for the product i.e. the grantee of the authorisation | |
| product |
1..* | Reference(Product) | Products that are covered under this authorization | |
| validityPeriod |
0..1 | Period | Validity Period of this authorization | |
| Documentation for this format | ||||
Terminology Bindings (Differential)
| Path | Conformance | ValueSet | URI |
| ProductAuthorization.status | extensible | Status (a valid code from Product and regulatory authorization status)http://smart.who.int/pcmt/ValueSet/Statusfrom this IG | |
| ProductAuthorization.type | extensible | RegulationType (a valid code from http://smart.who.int/pcmt/CodeSystem/RegulationType)http://smart.who.int/pcmt/ValueSet/RegulationTypefrom this IG |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ProductAuthorization |
0..* | Base | Product Authorization Instances of this logical model can be the target of a Reference | |
| number |
0..1 | Identifier | The identifier of the authorisation for the Products | |
| status |
1..1 | code | Product status Binding: Status for a Product (extensible) | |
| type |
1..1 | code | Regulation type Binding: Regulation Type for a Regulated Product (extensible) | |
| jurisdiction |
1..* | CodeableConcept | The jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued | |
| holder |
1..1 | Reference(mCSD Organization) | The organisation responsible for the product i.e. the grantee of the authorisation | |
| product |
1..* | Reference(Product) | Products that are covered under this authorization | |
| validityPeriod |
0..1 | Period | Validity Period of this authorization | |
| Documentation for this format | ||||
Terminology Bindings
| Path | Conformance | ValueSet | URI |
| ProductAuthorization.status | extensible | Status (a valid code from Product and regulatory authorization status)http://smart.who.int/pcmt/ValueSet/Statusfrom this IG | |
| ProductAuthorization.type | extensible | RegulationType (a valid code from http://smart.who.int/pcmt/CodeSystem/RegulationType)http://smart.who.int/pcmt/ValueSet/RegulationTypefrom this IG |
This structure is derived from Base
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ProductAuthorization |
0..* | Base | Product Authorization Instances of this logical model can be the target of a Reference | |
| number |
0..1 | Identifier | The identifier of the authorisation for the Products | |
| status |
1..1 | code | Product status Binding: Status for a Product (extensible) | |
| type |
1..1 | code | Regulation type Binding: Regulation Type for a Regulated Product (extensible) | |
| jurisdiction |
1..* | CodeableConcept | The jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued | |
| holder |
1..1 | Reference(mCSD Organization) | The organisation responsible for the product i.e. the grantee of the authorisation | |
| product |
1..* | Reference(Product) | Products that are covered under this authorization | |
| validityPeriod |
0..1 | Period | Validity Period of this authorization | |
| Documentation for this format | ||||
Terminology Bindings
| Path | Conformance | ValueSet | URI |
| ProductAuthorization.status | extensible | Status (a valid code from Product and regulatory authorization status)http://smart.who.int/pcmt/ValueSet/Statusfrom this IG | |
| ProductAuthorization.type | extensible | RegulationType (a valid code from http://smart.who.int/pcmt/CodeSystem/RegulationType)http://smart.who.int/pcmt/ValueSet/RegulationTypefrom this IG |
Differential View
This structure is derived from Base
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ProductAuthorization |
0..* | Base | Product Authorization Instances of this logical model can be the target of a Reference | |
| number |
0..1 | Identifier | The identifier of the authorisation for the Products | |
| status |
1..1 | code | Product status Binding: Status for a Product (extensible) | |
| type |
1..1 | code | Regulation type Binding: Regulation Type for a Regulated Product (extensible) | |
| jurisdiction |
1..* | CodeableConcept | The jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued | |
| holder |
1..1 | Reference(mCSD Organization) | The organisation responsible for the product i.e. the grantee of the authorisation | |
| product |
1..* | Reference(Product) | Products that are covered under this authorization | |
| validityPeriod |
0..1 | Period | Validity Period of this authorization | |
| Documentation for this format | ||||
Terminology Bindings (Differential)
| Path | Conformance | ValueSet | URI |
| ProductAuthorization.status | extensible | Status (a valid code from Product and regulatory authorization status)http://smart.who.int/pcmt/ValueSet/Statusfrom this IG | |
| ProductAuthorization.type | extensible | RegulationType (a valid code from http://smart.who.int/pcmt/CodeSystem/RegulationType)http://smart.who.int/pcmt/ValueSet/RegulationTypefrom this IG |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ProductAuthorization |
0..* | Base | Product Authorization Instances of this logical model can be the target of a Reference | |
| number |
0..1 | Identifier | The identifier of the authorisation for the Products | |
| status |
1..1 | code | Product status Binding: Status for a Product (extensible) | |
| type |
1..1 | code | Regulation type Binding: Regulation Type for a Regulated Product (extensible) | |
| jurisdiction |
1..* | CodeableConcept | The jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued | |
| holder |
1..1 | Reference(mCSD Organization) | The organisation responsible for the product i.e. the grantee of the authorisation | |
| product |
1..* | Reference(Product) | Products that are covered under this authorization | |
| validityPeriod |
0..1 | Period | Validity Period of this authorization | |
| Documentation for this format | ||||
Terminology Bindings
| Path | Conformance | ValueSet | URI |
| ProductAuthorization.status | extensible | Status (a valid code from Product and regulatory authorization status)http://smart.who.int/pcmt/ValueSet/Statusfrom this IG | |
| ProductAuthorization.type | extensible | RegulationType (a valid code from http://smart.who.int/pcmt/CodeSystem/RegulationType)http://smart.who.int/pcmt/ValueSet/RegulationTypefrom this IG |
This structure is derived from Base