SPL Mapping FHIR R5 Implementation Guide
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SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. 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/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

Artifacts Summary

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

Logical Models

Logical models that show the data elements for each use case

Establishment Registration Logical Model

An operation to register Establishment organizations.

GDUFA Facility Identification Logical Model

An operation to provide details about a GDUFA Facility.

NDC Labeler Code Request Logical Model

An operation to request a NDC Labeler code for a registrant or private Labeler organization.

Product Submission Document Logical Model

A document that contains information about a product being submitted for approval to the FDA.

Submitted Medication Logical Model

Details about the Medication that is submitted to the FDA.

Operation Bundles

Bundle profiles that are used in the various use case operations

EstablishmentInactivationBundle

A profile that represents the Bundle that contains all of the resources for an Estabishment Inactivation Request.

EstablishmentRegistrationBundle

A profile that represents the Bundle that contains all of the resources for an Estabishment Registration Request.

GDUFAFacilityIdentificationBundle

A profile that represents the Bundle that contains all of the resources for a GDUFA Facility Identification Request.

GDUFAFacilityInactivationBundle

A profile that represents the Bundle that contains all of the resources for an GDUFA Facility Inactivation Request.

LabelerCodeRequestBundle

A profile that represents the Bundle that contains all of the resources for a Labeler NDC Code Request.

LabelerInactivationBundle

A profile that represents the Bundle that contains all of the resources for a Labeler Inactivation.

OrganizationBundle

A profile that provides the minimum set of information about a Bundle using for Organization messages.

OutOfBusinessBundle

A profile that represents the Bundle that contains all of the resources for an Out of Business Notifcation.

Operation Message

MessageHeader profiles that are used in the various use case operations

EstablishmentInactivationMessage

A profile of an Establishment Inactivation message

EstablishmentRegistrationMessage

A profile of an Establishment Registration message

GDUFAFacilityIdentificationMessage

A profile of a GDUFA Facility Identification message

GDUFAFacilityInactivationMessage

A profile of an GDUFA Facility Inactivation message

LabelerCodeRequestMessage

An example of a message header for a Labeler Code Request

LabelerInactivationMessage

A profile for the Labeler Inactivation Message.

OrganizationMessage

An abstract profile that indicates what type of request is being made.

OutOfBusinessMessage

A profile of an Establishment Registration message

FDA Labeler Organizations

Artifacts associated with the Labeler Organization use cases

IdentifiedLabeler

A profile for an identified labeler.

LabelerBusinessOperation

A profile that associates a Labeler to the set of business operations that it can perform.

LabelerOrganization

A profile for the data elements required to identify a NDC Labeler organization.

FDA Establishment Organizations

Artifacts associated with the Estabishment Organization use cases

EstablishmentAffiliation

A profile that associates an registrant to the establishments it is registering.

EstablishmentBusinessOperation

A profile that associates an establishment to the set of business operations that it can perform.

EstablishmentOrganization

A profile for the data elements required to identify an organization that is registered as an Establishment.

EstablishmentRegistrantOrganization

A specialization of the RegistrantOrganization profile that fixes the type to EstablishmentRegistrant

IdentifiedEstablishment

A profile for an identified establishment.

IdentifiedEstablishmentRegistrant

A profile for an identified establishment registrant.

GDUFA Facility Identification

Artifacts associated with the GDUFA Facility Identification use cases

GDUFAFacilityAffiliation

A profile that associates a GDUFA facility to its registrant.

GDUFAFacilityBusinessOperation

A profile that associates an establishment to the set of business operations that it can perform.

GDUFAFacilityOrganization

A profile for the data elements required to identify an organization that is identified as a GDUFA Facility.

GDUFARegistrantOrganization

A specialization of the RegistrantOrganization profile that fixes the type to GDUFARegistrant.

IdentifiedGDUFAFacility

A profile for an identified GDUFA facility.

IdentifiedGDUFARegistrant

A profile for an identified GDUFA facility registrant.

General Organization Structures

Artifacts that are used in any of the Organization use cases

IdentifiedOrganization

A profile on Organization that specifies a name and an identifier used to identify rather than specify the organization.

ImporterAffiliation

A profile that associates an organization to its import organization.

ImporterOrganization

A profile for the data elements required for an organization fulfilling the role of an importer for another organization.

RegistrantOrganization

A profile for the data elements required to identify an organization that registers organizations and facilities.

SPLAddress

SPL-specific Constraints on the Address datatype dealing with US addresses.

SPLContactPoint

SPL-specific Constraints on the ContactPoint dealing with proper formatting

USAgentAffiliation

A profile that associates an organization to its US Agent.

USAgentOrganization

A profile for the data elements required for an organization fulfilling the role of a US Agent for another organization.

Product Submission Content

Artifacts associated with the submission of a product document

Manufactured Item Marketing Status Date Range

Used to indicate the date range of the marketing status of a manufactured item. This is being added in R5.

Packaged Product Reference

A reference to a packaged product that is represented in a packaging element.

ProductSubmissionBundle

A profile that represents the Bundle that contains the Product Submission document.

ProductSubmissionDocument

A profile that represents a document that is required for Product Submission to the FDA.

SectionEffectiveTime

Providing an effective time for a section.

SectionLinkId

Provide the ID that is using for linking between sections. NOTE: This will also be contained in the section text as a link.

SubmittedIngredientDefinition

Used to represent an substance's active moiety.

SubmittedManufacturedItem

Details around the actual item, i.e tablet, solution, etc. that is packaged as part of the medicinal product.

SubmittedMedicinalPackaging

Details around the packaging of submitted medicinal products.

SubmittedMedicinalProduct

A profile that allows for the submission of Medicinal Product information to the FDA.

SubmittedMedicinalProductIngredient

Details around the ingredients of a submitted medicinal product.

SubmittedMedicinalProductMarketing

Details around the marketing of a submitted medicinal product.

VersionNumber

Adding a version number to documents.

Dual Submission Tracking

Artifacts needed for tracking dual submissions of SPL documents and FHIR Bundles

DualSubmissionProvenance

A profile that links changes made to a FHIR system either via a converted SPL document or that are sent to a SPL system

SPLDocumentDate

Adding a SPL creation date to the document reference.

SPLDocumentReference

A profile that represents the SPL document that was either created by or was the source for the Organization FHIR Bundle.

Allopurinol Label

Example Instances associated with the label for Allopurinol USP

AidarexPharmaceuticals

Aidarex Pharmaceuticals - labeller for Allopurinol Tablets USP

Allopurinol100Tablets

100 Tablets Bottle of Allopurinol USP

Allopurinol30Tablets

30 Tablets Bottle of Allopurinol USP

Allopurinol60Tablets

60 Tablets Bottle of Allopurinol USP

Allopurinol90Tablets

90 Tablets Bottle of Allopurinol USP

Allopurinol<br/>Tablets USP<br/>Revised: February 2015<br/>Rx only        <br/>

Header information for the Allopurinol Tablet USP Label

AllopurinolIngredientDefinition

Active Ingredient Information for Allupurinol USP

AllopurinolMarketing

Marketing information for Allopurinol USP

AllopurinolTablet
AllopurinolTabletLabelBundle

A bundle containing all of the information for the Allopurinol Tablet USP Label

AllopurinolUSPActiveIngredient

Active Ingredient Strength for Allupurinol USP

AllopurinolUSPDefinition

Structured information for the Allopurinol Tablet USP Label

AllopurinolUSPIngredient1

Inactive Ingredient #1 for Allopurinol USP

AllopurinolUSPIngredient2

Inactive Ingredient #2 for Allopurinol USP

AllopurinolUSPIngredient3

Inactive Ingredient #3 for Allopurinol USP

AllopurinolUSPIngredient4

Inactive Ingredient #4 for Allopurinol USP

AllopurinolUSPIngredient5

Inactive Ingredient #5 for Allopurinol USP

AllopurinolUSPIngredient6

Inactive Ingredient #6 for Allopurinol USP

Enbrel Label

Example Instances associated with the label for Enbrel

Enbrel010Definition

Structured information for the Enbrel 010 Label

Enbrel010Marketing

Marketing information for Enbrel 010

Enbrel010Package

4 0.5mL syringes of Enbrel

Enbrel021Definition

Structured information for the Enbrel 021 Label

Enbrel021Marketing

Marketing information for Enbrel 021

Enbrel021Package

4 1mL Syringes of Enbrel

Enbrel032Definition

Structured information for the Enbrel 032 Label

Enbrel032Marketing

Marketing information for Enbrel 032

Enbrel032Package

4 1mL autoinjectors of Enbrel

Enbrel044Definition

Structured information for the Enbrel 044 Label

Enbrel044Marketing

Marketing information for Enbrel 044

Enbrel044Package

4 1mL cartridges of Enbrel

Enbrel055Definition

Structured information for the Enbrel 055 Label

Enbrel055Marketing

Marketing information for Enbrel 055

Enbrel055Package

4 0.5mL syringes of Enbrel

Enbrel25mgSolution
Enbrel25mgSolutionActiveIngredient

Active Ingredient Strength for Enbrel

Enbrel25mgSolutionIngredient1

Inactive Ingredient #1 for Enbrel 25mg Solution

Enbrel25mgSolutionIngredient2

Inactive Ingredient #2 for Enbrel 25mg Solution

Enbrel25mgSolutionIngredient3

Inactive Ingredient #3 for Enbrel 25mg Solution

Enbrel425Definition

Structured information for the Enbrel 425 Label

Enbrel425Marketing

Marketing information for Enbrel 425

Enbrel425Package

4 25mg kits of Enbrel

Enbrel425Part1Definition

Structured information for the Enbrel 425 Part 1

Enbrel425Part1Marketing

Marketing information for Enbrel 425 Part 1

Enbrel425Part1Package

1 vial of Enbrel powder

Enbrel425Part2Definition

Structured information for the Enbrel 425 Part 2

Enbrel425Part2Marketing

Marketing information for Enbrel 425 Part 2

Enbrel425Part2Package

1 syringe of sterile bacteriostatic water

Enbrel435Definition

Structured information for the Enbrel 435 Label

Enbrel435Marketing

Marketing information for Enbrel 435

Enbrel435Package

4 1mL Syringes of Enbrel

Enbrel445Definition

Structured information for the Enbrel 445 Label

Enbrel445Marketing

Marketing information for Enbrel 445

Enbrel445Package

4 1mL autoinjectors of Enbrel

Enbrel446Definition

Structured information for the Enbrel 446 Label

Enbrel446Marketing

Marketing information for Enbrel 446

Enbrel446Package

4 1mL autoinjectors of Enbrel

Enbrel455Definition

Structured information for the Enbrel 455 Label

Enbrel455Marketing

Marketing information for Enbrel 455

Enbrel455Package

4 0.5mL syringes of Enbrel

Enbrel456Definition

Structured information for the Enbrel 456 Label

Enbrel456Marketing

Marketing information for Enbrel 456

Enbrel456Package

4 1mL cartridges of Enbrel

Enbrel50mgSolution
Enbrel50mgSolutionActiveIngredient

Active Ingredient Strength for Enbrel

Enbrel50mgSolutionIngredient1

Inactive Ingredient #1 for Enbrel Solution

Enbrel50mgSolutionIngredient2

Inactive Ingredient #2 for Enbrel Solution

Enbrel50mgSolutionIngredient3

Inactive Ingredient #3 for Enbrel Solution

EnbrelIngredientDefinition

Active Ingredient Information for Enbrel

EnbrelPowder
EnbrelPowderActiveIngredient

Active Ingredient Strength for Enbrel Powder

EnbrelPowderIngredient1

Inactive Ingredient #1 for Enbrel Powder

EnbrelPowderIngredient2

Inactive Ingredient #2 for Enbrel Powder

EnbrelPowderIngredient3

Inactive Ingredient #3 for Enbrel Powder

EnbrelSterileSolution
EnbrelSterileSolutionIngredient1

Inactive Ingredient #1 for Enbrel Sterile Solution

EnbrelSterileSolutionIngredient2

Inactive Ingredient #2 for Enbrel Sterile Solution

EnbrelSyringeLabelBundle

A bundle containing all of the information for the Enbrel Label

ImmunexCorporation

Immunex Corporation - labeller for Enbrel

These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. <br/> <br/>ENBREL<sup>®</sup> (etanercept) injection, for subcutaneous use <br/>ENBREL<sup>®</sup> (etanercept) for injection, for subcutaneous use <br/>Initial U.S. Approval: 1998

Header information for the Enbrel Syringe Labels

Lantus Label

Example Instances associated with the label for Lantus

LantusActiveIngredient

Active Ingredient Strength for Lantus

LantusIngredient1

Inactive Ingredient #1 for Lantus

LantusIngredient2

Inactive Ingredient #2 for Lantus

LantusIngredient3

Inactive Ingredient #3 for Lantus

LantusIngredient4

Inactive Ingredient #4 for Lantus

LantusIngredient5

Inactive Ingredient #5 for Lantus

LantusIngredient6

Inactive Ingredient #6 for Lantus

LantusIngredient7

Inactive Ingredient #7 for Lantus

LantusIngredientDefinition

Active Ingredient Information for Lantus

LantusInjectionLabelBundle

A bundle containing all of the information for the Lantus Injection Label

LantusSolution
LantusSyringeDefinition

Structured information for the Lantus Syringe product

LantusSyringeMarketing

Marketing information for Lantus Syringe

LantusSyringePackage

Lantus Syringe Packaging

LantusVialDefinition

Structured information for the Lantus Vial product

LantusVialMarketing

Marketing information for Lantus Vial

LantusVialPackage

Lantus Vial Packaging

SanofiAventisDeutschland

Sanifo-Aventis Deutschland - establishment for Lantus Injection

SanofiAventisSRL

Sanifo-Aventis SRL - establishment for Lantus Injection

SanofiAventisUS

Sanifo-Aventis US - labeller for Lantus Injection

These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. <br/> <br/>LANTUS<sup>®</sup> (insulin glargine injection) for subcutaneous injection <br/>Initial U.S. Approval: 2000

Header information for the Lantus Injection Label

Behavior: Search Parameters

These define the properties by which a RESTful server can be searched. They can also be used for sorting and including related resources.

ProvenanceActivitySearchParameter

A search parameter to allow searching for Provenance records by activity type.

Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide.

All NDC Products

A value set that is all of the NDC codesystem, i.e. all NDC products

Business Operation Qualifiers

Codes that give further information about an organization's business operation.

Establishment Business Operations

The set of business operations that can be specified for an establishment.

GDUFA Facility Business Operation Qualifiers

Codes that give further information about a GUDFA facility's business operation.

GDUFA Facility Business Operations

The set of business operations that can be specified for a GDUFA facility.

Generic Facility Message Types

The set of message types that are allowed as a Generic User Fee Facility submission.

Labeler Business Operations

The set of business operations that can be specified for a labelling facility.

Organzation Submission Message Types

The set of message types that are allowed as a FHIR organization submission.

Registrant Organization Types

Codes that are specifically used for Registration Organizations.

SPL Color

Codes from NCI Thesaurus for SPL Color (C54453 Subset)

SPL Combo Product Type

Codes from NCI Thesaurus for SPL Combo Product Type (C102833 Subset)

SPL Document Codes

Document Codes for SPL Product Submission documents

SPL Dose Form

Codes from NCI Thesaurus for SPL Dose Form (C54456 Subset)

SPL Flavor

Codes from NCI Thesaurus for SPL Flavor (C73339 Subset)

SPL Marketing Categories

Codes from NCI Thesaurus for SPL Marketing Categories (C43164 Subset)

SPL Marketing Statuses ValueSet

Marketing Status Status Codes

SPL Operation Type

Codes from NCI Thesaurus for SPL Operation Type (C73600 Subset)

SPL Package Types

Codes from NCI Thesaurus for SPL Package Types (C43164 Subset)

SPL Product Characteristic Types ValueSet

Codes that identify the types of characteristics allowed for Submitted Medicinal Product.

SPL Route of Administration

Codes from NCI Thesaurus for SPL Route of Administration (C54455 Subset)

SPL Section Codes

Section Codes for SPL Product Submission documents

SPL Shape

Codes from NCI Thesaurus for SPL Shape (C54454 Subset)

SPL Special Measures

Codes from NCI Thesaurus for SPL Special Measures (C54459 Subset)

Top-Level Organization Types

Codes that identify organizations that are considered top-level

Terminology: Code Systems

These define new code systems used by systems conforming to this implementation guide.

FHIR Specific SPL Message Types

Codes that are unique to the FHIR organization submissions, i.e. these are not current SPL submission types.

Medicinal Product Name Types CodeSystem

Codes that types of names for a medicinal product.

Organization Relationship Types

Codes that identify the relationship between two organizations.

SPL Marketing Statuses CodeSystem

Marketing Status Status Codes

SPL Organization Types

Codes that identify the types of organizations involved in a SPL submission.

SPL Product Characteristic Types CodeSystem

Codes that were specified in the SPL guide for characteristic types.

Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.

EnbrelKit
ExampleEstablishment

An example of an Establishment Organization.

ExampleEstablishmentAffiliation

An example of an affiliation between a registrant and an establishment.

ExampleEstablishmentFHIRtoSPLProvenance

A Provenance record that associates a set of FHIR Registrant and Establishment Organizations with a generated SPL document.

ExampleEstablishmentOperation

An example of a Establishment's business operations.

ExampleEstablishmentRegistrant

An example of a Registrant Organization.

ExampleEstablishmentRegistration

An example of a Bundle containing a set of Establishment Registration resources to register.

ExampleEstablishmentSPLtoFHIRProvenance

A Provenance record that associates a set of FHIR Registrant and Establishment Organizations with a submitted SPL document.

ExampleGDUFAFacility

An example of an GDUFA Facility Organization.

ExampleGDUFAFacilityAffiliation

An example of an affiliation between a registrant and a GDUFA facility.

ExampleGDUFAFacilityIdentification

An example of a Bundle containing a set of GDUFA Facility resources to identify.

ExampleGDUFAFacilityInactivation

An example of a Bundle containing a set of GDUFA Facility resources to inactivate.

ExampleGDUFAFacilityOperation

An example of a GDUFA Facility's business operations.

ExampleGDUFARegistrant

An example of a Registrant Organization.

ExampleImporter

An example of an Importer Organization.

ExampleImporterAffiliation

An example of the linkage between an Establishment and an Importer

ExampleLabelerFHIRtoSPLProvenance

A Provenance record that associates a set of FHIR Labeler Organizations with a generated SPL document.

ExampleLabelerSPLtoFHIRProvenance

A Provenance record that associates a set of FHIR Labeler Organizations with a submitted SPL document.

ExampleSPLDocumentReference

An example of an SPL document that will be attached to a FHIR Provenance.

IdentifiedLabelerOrganization

A sample Labeler organizaiton that just has the DUNS number and name.

SamplOutOfBusinessMessage

An example of a message header for an Out of Business notification

SampleEstablishmentInactivationBundle

An example of a Bundle containing a set of Establishment resources to inactivate.

SampleEstablishmentInactivationMessage

An example of a message header for a Establishment Inactivation

SampleEstablishmentRegistrationMessage

An example of an Establishment Registration message

SampleGDUFAFacilityIdentificationMessage

An example of a GDUFA Facility Identification message

SampleGDUFAFacilityInactivationMessage

An example of a GDUFA Facility Identification message

SampleIdentifiedEstablishment

A sample Establishment organizaiton that just has the DUNS number and name.

SampleIdentifiedEstablishmentRegistrant

A sample Establishment Registrant organization that just has the DUNS number and name.

SampleIdentifiedGDUFAFacility

An example of an Identified GDUFA Facility Organization.

SampleIdentifiedGDUFARegistrant

An example of a Identified Registrant Organization.

SampleLabelerBusinessOperation

An example of a Labeler's business operations.

SampleLabelerCodeRequestBundle

An example of a Bundle containing a Labeler Code Request resource to register.

SampleLabelerCodeRequestMessage

An example of a message header for a Labeler Code Request

SampleLabelerInactivationBundle

An example of a Bundle containing a Labeler Code Request resource to inactivate.

SampleLabelerInactivationMessage

An example of a message header for a Labeler Inactivation

SampleLabelerOrganization

An example of a Labeler Organization.

SampleLabelerUSAgent

An example of a US Agent Organization.

SampleLabelerUSAgentAffiliation

An example of the linkage between a Labeler and a US Agent

SampleOutOfBusinessNotificationBundle

An example of a Bundle containing a set of Establishment resources to inactivate.