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/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: 0.2.0
Draft as of 2026-02-18 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.

Usages:

  • This Logical Model is not used by any profiles in this Implementation Guide

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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)
... 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ProductAuthorization.​status Base extensible Status for a Product 📦0.2.0 This IG
ProductAuthorization.​type Base extensible Regulation Type for a Regulated Product 📦0.2.0 This IG

API Information

Product Authorization API

A record of authorization or compliance for one or more Products with a set of regulatory, policy, (pre-)qualification, or legal requirements.

Version: 1.0.0

Endpoints

GET /StructureDefinition-ProductAuthorization.schema.json

JSON Schema definition for the Logical Model StructureDefinition-ProductAuthorization

This endpoint serves the JSON Schema definition for the Logical Model StructureDefinition-ProductAuthorization.

Schema Definition

StructureDefinition-ProductAuthorization

Description: A record of authorization or compliance for one or more Products with a set of regulatory, policy, (pre-)qualification, or legal requirements.

Type: object

Full Schema (JSON)

{
  "$schema": "https://json-schema.org/draft/2020-12/schema",
  "$id": "http://smart.who.int/base/StructureDefinition-ProductAuthorization.schema.json",
  "title": "Product Authorization",
  "description": "A record of authorization or compliance for one or more Products with a set of regulatory, policy, (pre-)qualification, or legal requirements.",
  "type": "object",
  "properties": {
    "resourceType": {
      "type": "string",
      "const": "ProductAuthorization",
      "description": "Resource type identifier for ProductAuthorization logical model"
    },
    "@context": {
      "description": "JSON-LD context for this logical model with ValueSet vocabularies",
      "anyOf": [
        {
          "type": "string",
          "format": "uri",
          "description": "URI reference to external JSON-LD context"
        },
        {
          "type": "object",
          "description": "Inline JSON-LD context",
          "properties": {
            "@version": {
              "type": "number",
              "const": 1.1
            },
            "fhir": {
              "type": "string",
              "const": "http://hl7.org/fhir/"
            }
          },
          "additionalProperties": {
            "type": "string",
            "format": "uri"
          }
        },
        {
          "type": "array",
          "description": "Array of JSON-LD context objects/URIs",
          "items": {
            "anyOf": [
              {
                "type": "string",
                "format": "uri"
              },
              {
                "type": "object"
              }
            ]
          }
        }
      ]
    },
    "@type": {
      "type": "string",
      "description": "JSON-LD type identifier for ProductAuthorization logical model",
      "examples": [
        "LogicalModel-ProductAuthorization"
      ]
    },
    "number": {
      "type": "object",
      "description": "The identifier of the authorisation for the Products"
    },
    "status": {
      "oneOf": [
        {
          "type": "string",
          "description": "Code from ValueSet Status (plain string)"
        },
        {
          "type": "object",
          "description": "Code from ValueSet Status (JSON-LD structure)",
          "properties": {
            "@type": {
              "type": "string",
              "const": "http://smart.who.int/base/ValueSet-Status.jsonld",
              "description": "JSON-LD type reference to ValueSet Status"
            },
            "@id": {
              "type": "string",
              "format": "uri",
              "description": "Full IRI of the code from ValueSet Status"
            }
          },
          "required": [
            "@type",
            "@id"
          ],
          "additionalProperties": false
        }
      ],
      "description": "The status of the authoriation e.g. 'active' 'inactive'"
    },
    "type": {
      "oneOf": [
        {
          "type": "string",
          "description": "Code from ValueSet RegulationType (plain string)"
        },
        {
          "type": "object",
          "description": "Code from ValueSet RegulationType (JSON-LD structure)",
          "properties": {
            "@type": {
              "type": "string",
              "const": "http://smart.who.int/base/ValueSet-RegulationType.jsonld",
              "description": "JSON-LD type reference to ValueSet RegulationType"
            },
            "@id": {
              "type": "string",
              "format": "uri",
              "description": "Full IRI of the code from ValueSet RegulationType"
            }
          },
          "required": [
            "@type",
            "@id"
          ],
          "additionalProperties": false
        }
      ],
      "description": "The type of authorization (e.g. pre-qualification)"
    },
    "jurisdiction": {
      "type": "array",
      "items": {
        "type": "object"
      },
      "minItems": 1,
      "description": "The jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued"
    },
    "holder": {
      "type": "object",
      "description": "The organisation responsible for the product i.e. the grantee of the authorisation"
    },
    "product": {
      "type": "array",
      "items": {
        "type": "object",
        "description": "FHIR Reference"
      },
      "minItems": 1,
      "description": "Products that are covered under this authorization"
    },
    "validityPeriod": {
      "type": "object",
      "description": "Validity Period of this authorization"
    }
  },
  "required": [
    "resourceType",
    "status",
    "type",
    "jurisdiction",
    "holder",
    "product"
  ],
  "resourceDefinition": "http://smart.who.int/pcmt/StructureDefinition/ProductAuthorization",
  "fhir:parent": "http://hl7.org/fhir/StructureDefinition/Base",
  "jsonld:valuesets": [
    "Status",
    "RegulationType"
  ],
  "jsonld:contextTemplate": {
    "@version": 1.1,
    "fhir": "http://hl7.org/fhir/",
    "Status": "http://smart.who.int/base/ValueSet-Status.jsonld",
    "RegulationType": "http://smart.who.int/base/ValueSet-RegulationType.jsonld"
  }
}

This documentation is automatically generated from the OpenAPI specification.

This structure is derived from Base

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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)
... 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

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
ProductAuthorization.​status Base extensible Status for a Product 📦0.2.0 This IG
ProductAuthorization.​type Base extensible Regulation Type for a Regulated Product 📦0.2.0 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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)
... 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ProductAuthorization.​status Base extensible Status for a Product 📦0.2.0 This IG
ProductAuthorization.​type Base extensible Regulation Type for a Regulated Product 📦0.2.0 This IG

This structure is derived from Base

Summary

Mandatory: 0 element(5 nested mandatory elements)

Structures

This structure refers to these other structures:

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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)
... 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ProductAuthorization.​status Base extensible Status for a Product 📦0.2.0 This IG
ProductAuthorization.​type Base extensible Regulation Type for a Regulated Product 📦0.2.0 This IG

Differential View

This structure is derived from Base

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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)
... 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

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
ProductAuthorization.​status Base extensible Status for a Product 📦0.2.0 This IG
ProductAuthorization.​type Base extensible Regulation Type for a Regulated Product 📦0.2.0 This IG

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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)
... 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ProductAuthorization.​status Base extensible Status for a Product 📦0.2.0 This IG
ProductAuthorization.​type Base extensible Regulation Type for a Regulated Product 📦0.2.0 This IG

This structure is derived from Base

Summary

Mandatory: 0 element(5 nested mandatory elements)

Structures

This structure refers to these other structures:

 

Other representations of profile: CSV, Excel