SMART Product Catalog
0.1.0 - ci-build

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: ProductAuthorization - Detailed Descriptions

Draft as of 2025-03-06

Definitions for the ProductAuthorization logical model.

Guidance on how to interpret the contents of this table can be found here

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.

ShortProduct Authorization
Control0..*
Is Modifierfalse
Logical ModelInstances 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

ShortThe identifier of the authorisation for the Products
Control0..1
TypeIdentifier
4. ProductAuthorization.status
Definition

The status of the authoriation e.g. 'active' 'inactive'

ShortProduct status
Control1..1
BindingUnless not suitable, these codes SHALL be taken from Status for a Product
(extensible to http://smart.who.int/pcmt/ValueSet/Status)
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
6. ProductAuthorization.type
Definition

The type of authorization (e.g. pre-qualification)

ShortRegulation type
Control1..1
BindingUnless not suitable, these codes SHALL be taken from Regulation Type for a Regulated Product
(extensible to http://smart.who.int/pcmt/ValueSet/RegulationType)
Typecode
Primitive ValueThis 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

ShortThe jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued
Control1..*
TypeCodeableConcept
10. ProductAuthorization.holder
Definition

The organisation responsible for the product i.e. the grantee of the authorisation

ShortThe organisation responsible for the product i.e. the grantee of the authorisation
Control1..1
TypeReference(mCSD Organization)
12. ProductAuthorization.product
Definition

Products that are covered under this authorization

ShortProducts that are covered under this authorization
Control1..*
TypeReference(Product)
14. ProductAuthorization.validityPeriod
Definition

Validity Period of this authorization

ShortValidity Period of this authorization
Control0..1
TypePeriod

Guidance on how to interpret the contents of this table can be found here

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.

ShortProduct Authorization
Logical ModelInstances 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

ShortThe identifier of the authorisation for the Products
Control0..1
TypeIdentifier
4. ProductAuthorization.status
Definition

The status of the authoriation e.g. 'active' 'inactive'

ShortProduct status
Control1..1
BindingUnless not suitable, these codes SHALL be taken from Status for a Product
(extensible to http://smart.who.int/pcmt/ValueSet/Status)
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
6. ProductAuthorization.type
Definition

The type of authorization (e.g. pre-qualification)

ShortRegulation type
Control1..1
BindingUnless not suitable, these codes SHALL be taken from Regulation Type for a Regulated Product
(extensible to http://smart.who.int/pcmt/ValueSet/RegulationType)
Typecode
Primitive ValueThis 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

ShortThe jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued
Control1..*
TypeCodeableConcept
10. ProductAuthorization.holder
Definition

The organisation responsible for the product i.e. the grantee of the authorisation

ShortThe organisation responsible for the product i.e. the grantee of the authorisation
Control1..1
TypeReference(mCSD Organization)
12. ProductAuthorization.product
Definition

Products that are covered under this authorization

ShortProducts that are covered under this authorization
Control1..*
TypeReference(Product)
14. ProductAuthorization.validityPeriod
Definition

Validity Period of this authorization

ShortValidity Period of this authorization
Control0..1
TypePeriod

Guidance on how to interpret the contents of this table can be found here

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.

ShortProduct Authorization
Control0..*
Is Modifierfalse
Logical ModelInstances 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

ShortThe identifier of the authorisation for the Products
Control0..1
TypeIdentifier
4. ProductAuthorization.status
Definition

The status of the authoriation e.g. 'active' 'inactive'

ShortProduct status
Control1..1
BindingUnless not suitable, these codes SHALL be taken from Status for a Product
(extensible to http://smart.who.int/pcmt/ValueSet/Status)
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
6. ProductAuthorization.type
Definition

The type of authorization (e.g. pre-qualification)

ShortRegulation type
Control1..1
BindingUnless not suitable, these codes SHALL be taken from Regulation Type for a Regulated Product
(extensible to http://smart.who.int/pcmt/ValueSet/RegulationType)
Typecode
Primitive ValueThis 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

ShortThe jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued
Control1..*
TypeCodeableConcept
10. ProductAuthorization.holder
Definition

The organisation responsible for the product i.e. the grantee of the authorisation

ShortThe organisation responsible for the product i.e. the grantee of the authorisation
Control1..1
TypeReference(mCSD Organization)
12. ProductAuthorization.product
Definition

Products that are covered under this authorization

ShortProducts that are covered under this authorization
Control1..*
TypeReference(Product)
14. ProductAuthorization.validityPeriod
Definition

Validity Period of this authorization

ShortValidity Period of this authorization
Control0..1
TypePeriod