SMART Product Catalog
0.2.0 - ci-build
SMART Product Catalog, published by WHO. This guide is not an authorized publication; it is the continuous build for version 0.2.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/WorldHealthOrganization/smart-pcmt/ and changes regularly. See the Directory of published versions
| Draft as of 2025-09-22 |
Definitions for the ProductAuthorization logical model.
Guidance on how to interpret the contents of this table can be foundhere
| 0. ProductAuthorization | |
| Definition | A record of authorization or compliance for one or more Products with a set of regulatory, policy, (pre-)qualification, or legal requirements. |
| Short | Product Authorization |
| Control | 0..* |
| Is Modifier | false |
| Logical Model | Instances of this logical model are not marked to be the target of a Reference |
| 2. ProductAuthorization.number | |
| Definition | The identifier of the authorisation for the Products |
| Short | The identifier of the authorisation for the Products |
| Control | 0..1 |
| Type | Identifier |
| 4. ProductAuthorization.status | |
| Definition | The status of the authoriation e.g. 'active' 'inactive' |
| Short | Product status |
| Control | 1..1 |
| Binding | Unless not suitable, these codes SHALL be taken from Status for a Product (extensible to http://smart.who.int/pcmt/ValueSet/Status) |
| Type | code |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 6. ProductAuthorization.type | |
| Definition | The type of authorization (e.g. pre-qualification) |
| Short | Regulation type |
| Control | 1..1 |
| Binding | Unless not suitable, these codes SHALL be taken from Regulation Type for a Regulated Product (extensible to http://smart.who.int/pcmt/ValueSet/RegulationType) |
| Type | code |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 8. ProductAuthorization.jurisdiction | |
| Definition | The jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued |
| Short | The jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued |
| Control | 1..* |
| Type | CodeableConcept |
| 10. ProductAuthorization.holder | |
| Definition | The organisation responsible for the product i.e. the grantee of the authorisation |
| Short | The organisation responsible for the product i.e. the grantee of the authorisation |
| Control | 1..1 |
| Type | Reference(mCSD Organization) |
| 12. ProductAuthorization.product | |
| Definition | Products that are covered under this authorization |
| Short | Products that are covered under this authorization |
| Control | 1..* |
| Type | Reference(Product) |
| 14. ProductAuthorization.validityPeriod | |
| Definition | Validity Period of this authorization |
| Short | Validity Period of this authorization |
| Control | 0..1 |
| Type | Period |
Guidance on how to interpret the contents of this table can be foundhere
| 0. ProductAuthorization | |
| Definition | A record of authorization or compliance for one or more Products with a set of regulatory, policy, (pre-)qualification, or legal requirements. |
| Short | Product Authorization |
| Logical Model | Instances of this logical model are not marked to be the target of a Reference |
| 2. ProductAuthorization.number | |
| Definition | The identifier of the authorisation for the Products |
| Short | The identifier of the authorisation for the Products |
| Control | 0..1 |
| Type | Identifier |
| 4. ProductAuthorization.status | |
| Definition | The status of the authoriation e.g. 'active' 'inactive' |
| Short | Product status |
| Control | 1..1 |
| Binding | Unless not suitable, these codes SHALL be taken from Status for a Product (extensible to http://smart.who.int/pcmt/ValueSet/Status) |
| Type | code |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 6. ProductAuthorization.type | |
| Definition | The type of authorization (e.g. pre-qualification) |
| Short | Regulation type |
| Control | 1..1 |
| Binding | Unless not suitable, these codes SHALL be taken from Regulation Type for a Regulated Product (extensible to http://smart.who.int/pcmt/ValueSet/RegulationType) |
| Type | code |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 8. ProductAuthorization.jurisdiction | |
| Definition | The jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued |
| Short | The jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued |
| Control | 1..* |
| Type | CodeableConcept |
| 10. ProductAuthorization.holder | |
| Definition | The organisation responsible for the product i.e. the grantee of the authorisation |
| Short | The organisation responsible for the product i.e. the grantee of the authorisation |
| Control | 1..1 |
| Type | Reference(mCSD Organization) |
| 12. ProductAuthorization.product | |
| Definition | Products that are covered under this authorization |
| Short | Products that are covered under this authorization |
| Control | 1..* |
| Type | Reference(Product) |
| 14. ProductAuthorization.validityPeriod | |
| Definition | Validity Period of this authorization |
| Short | Validity Period of this authorization |
| Control | 0..1 |
| Type | Period |
Guidance on how to interpret the contents of this table can be foundhere
| 0. ProductAuthorization | |
| Definition | A record of authorization or compliance for one or more Products with a set of regulatory, policy, (pre-)qualification, or legal requirements. |
| Short | Product Authorization |
| Control | 0..* |
| Is Modifier | false |
| Logical Model | Instances of this logical model are not marked to be the target of a Reference |
| 2. ProductAuthorization.number | |
| Definition | The identifier of the authorisation for the Products |
| Short | The identifier of the authorisation for the Products |
| Control | 0..1 |
| Type | Identifier |
| 4. ProductAuthorization.status | |
| Definition | The status of the authoriation e.g. 'active' 'inactive' |
| Short | Product status |
| Control | 1..1 |
| Binding | Unless not suitable, these codes SHALL be taken from Status for a Product (extensible to http://smart.who.int/pcmt/ValueSet/Status) |
| Type | code |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 6. ProductAuthorization.type | |
| Definition | The type of authorization (e.g. pre-qualification) |
| Short | Regulation type |
| Control | 1..1 |
| Binding | Unless not suitable, these codes SHALL be taken from Regulation Type for a Regulated Product (extensible to http://smart.who.int/pcmt/ValueSet/RegulationType) |
| Type | code |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 8. ProductAuthorization.jurisdiction | |
| Definition | The jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued |
| Short | The jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued |
| Control | 1..* |
| Type | CodeableConcept |
| 10. ProductAuthorization.holder | |
| Definition | The organisation responsible for the product i.e. the grantee of the authorisation |
| Short | The organisation responsible for the product i.e. the grantee of the authorisation |
| Control | 1..1 |
| Type | Reference(mCSD Organization) |
| 12. ProductAuthorization.product | |
| Definition | Products that are covered under this authorization |
| Short | Products that are covered under this authorization |
| Control | 1..* |
| Type | Reference(Product) |
| 14. ProductAuthorization.validityPeriod | |
| Definition | Validity Period of this authorization |
| Short | Validity Period of this authorization |
| Control | 0..1 |
| Type | Period |