CH IDMP (R5)
1.0.0-ballot - trial-use Switzerland flag

CH IDMP (R5) - Local Development build (v1.0.0-ballot) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Artifacts Summary

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

Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide.

AdministrableProductDefinition

Profile of the AdministrableProductDefinition resource for representing a medicinal product in the final form which is suitable for administering to a patient.

Bundle

Profile of the Bundle resource for representing the set of resources collected into a single package.

ClinicalUseDefinition Indication

Profile of the ClinicalUseDefinition resource for representing an indication.

DocumentReference

Profile of the DocumentReference resource for representing professional information and patient information as attachments.

Ingredient

Profile of the Ingredient resource for representing the material used in the preparation of a medicinal/pharmaceutical product.

ManufacturedItemDefinition

Profile of the ManufacturedItemDefinition resource for representing the characteristics of a medicinal manufactured item as contained in a packaged medicinal product.

MedicinalProductDefinition

Profile of the MedicinalProductDefinition resource for representing the detailed data of medicinal products.

Organization

Defines basic constraints and extensions on the Organization resource for use with other CH IDMP resources

PackagedProductDefinition

Profile of the PackagedProductDefinition resource for representing a medically related item or items, in a container or package.

RegulatedAuthorization

Profile of the RegulatedAuthorization resource for representing the market authorization of a (packaged) medicinal product.

Structures: Data Type Profiles

These define constraints on FHIR data types for systems conforming to this implementation guide.

EMA LOC Identifier

Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)

GLN Identifier

Identifier holding a number for GLN (Global Location Number)

SMC Identifier

Identifier holding a number for Organisations registered at Swissmedic

Structures: Extension Definitions

These define constraints on FHIR data types for systems conforming to this implementation guide.

CH SMC - Authorized Dose Form

Extension for representing the authorized dose form

Terminology: Value Sets

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

CH - Authorisation Type

Value Set for Authorisation Type in Switzerland used by FOPH

CH - Medicinal Product Name Type

Value Set for the Medicinal Product Name Type used in Switzerland

CH - Other Characteristics Type

Value Set for Other Characteristics

CH Refdata - Marketing Status

Value Set for the Marketingstatus from Refdata

CH SMC - Additional Monitoring Indicator

Value Set for the Additional Monitoring Indicator from SMC

CH SMC - Attached Document Type

Value Set for the Legal Status of Supply from SMC

CH SMC - Authorisation Category

Value Set for the Authorisation Category from SMC

CH SMC - Authorisation Status

Value Set for the Authorisation Status from SMC

CH SMC - Authorised Pharmaceutical Dose Form

Value Set for the Authorised Pharmaceutical Dose Form from SMC used by FOPH

CH SMC - Ingredient Role

Value Set for the Ingredient Role from SMC

CH SMC - Legal Status of Supply

Value Set for the Legal Status of Supply from SMC

CH SMC - Marketing Status

Value Set for the Marketingstatus from SMC

CH SMC - MedicinalProductCategory

Value Set for the MedicinalProductCategory from SMC

CH SMC - Pediatric Use Indicator

Value Set for the Pediatric Use Indicator from SMC

CH SMC - Special Precautions for Storage

Value Set for the Special Precautions for Storage from SMC

CH SMC - Substance

Value Set for the Substances from SMC

EDQM - Combination Packaging

Value Set for the Combination Packaging from EDQM used by SMC

EDQM - Combined Pharmaceutical Dose Form

Value Set for the Combined Pharmaceutical Dose Froms from EDQM used by SMC

EDQM - Combined Term

Value Set for the Combined Terms from EDQM used by SMC

EDQM - Packaging

Value Set for the Packaging from EDQM used by SMC

EDQM - Pharmaceutical Dose Form

Value Set for the Pharmaceutical Dose Form

EDQM - Route Of Administration

Value Set for the Route Of Administration from EDQM

EDQM - Unit of Presentation

Value Set for the Unit of Presentation from EDQM used by SMC

EMA - Domain

Value Set for the Domain from EMA used by SMC

EMA - Intended Effect

Value Set for the Intended Effect from EMA used by SMC

EMA - Shelf Life Type

Value Set for the Shelf Life Type from EMA used by SMC

Terminology: Code Systems

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

CH - Authorisation Type

CH EPL - Standard Terms used in Switzerland (aggregations of codes of ValueSets Authorisation Type

CH - Medicinal Product Name Type

CH - Standard Terms used in Switzerland (aggregations of codes of ValueSets Typ des Arzneimittelnamens)

CH - Other Characteristics Type

CH - Standard Terms to define the different other characteristics

CH Refdata - Marketing Status

CH - Standard Terms used in Switzerland (aggregations of codes of ValueSets Vermarktungsstatus)

CH SMC - Additional Monitoring Indicator

CH - Standard Terms used in Switzerland (aggregations of codes of ValueSets Additional Monitoring Indicator

CH SMC - Attached Document Type

CH - Standard Terms used in Switzerland (aggregations of codes of ValueSets Typ des Anhangs)

CH SMC - Authorisation Category

CH - Standard Terms used in Switzerland (aggregations of codes of ValueSets Authorisation Category)

CH SMC - Authorisation Status

CH - Standard Terms used in Switzerland (aggregations of codes of ValueSets Zulassungsstatus)

CH SMC - Ingredient Role

CH - Standard Terms used in Switzerland (aggregations of codes of ValueSets Funktion des Inhaltsstoffes)

CH SMC - Legal Status of Supply

CH - Standard Terms used in Switzerland (aggregations of codes of ValueSets Abgabekategorie)

CH SMC - Marketing Status

CH - Standard Terms used in Switzerland (aggregations of codes of ValueSets Vermarktungsstatus)

CH SMC - MedicinalProductCategory

CH - Standard Terms used in Switzerland (aggregations of codes of ValueSets MedicinalProductCategory)

CH SMC - Pediatric Use Indicator

CH - Standard Terms used in Switzerland (aggregations of codes of ValueSets Pediatric Use Indicator)

CH SMC - Special Precautions for Storage

CH - Standard Terms used in Switzerland (aggregations of codes of ValueSets Besondere Vorsichtsmassnahmen für die Aufbewahrung)

CH SMC - Substance

CH - Standard Terms used in Switzerland (aggregations of codes of ValueSets Substanzen)

EDQM - Standard Terms

EDQM - Standard Terms used in Switzerland (see original codes system defined in https://standardterms.edqm.eu/#)

EMA - Domain

CH - Standard Terms used in Switzerland (aggregations of codes of Value Set for the Domain from EMA used by SMC)

EMA - Intended Effect

CH - Standard Terms used in Switzerland (aggregations of codes of Value Set for the Intended Effect from EMA used by SMC)

EMA - Shelf Life Type

CH - Standard Terms used in Switzerland (aggregations of codes of Value Set for the Shelf Life Type from EMA used by SMC)

Terminology: Naming Systems

These define identifier and/or code system identities used by systems conforming to this implementation guide.

Application / Assessment Tracking Number

Temporary Namingsystem in this implementation guide until officially released by Swissmedic

Clinical Product Identifier

Temporary Identifier in this implementation guide until officially released by Swissmedic

FOPH Dossier Number

Identifier holding the Dossier number of FOPH

GLN Identifier

Identifier holding a number for GLN (Global Location Number)

Global Trade Item Number

GS1 defines trade items as products or services that are priced, ordered or invoiced at any point in the supply chain.

LOC Identifier

Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)

Marketing Authorisation Number

Temporary Identifier in this implementation guide until officially released by Swissmedic

Medical Product Identifier

Temporary Identifier in this implementation guide until officially released by Swissmedic

Pharmaceutical Product Identifier

Temporary Identifier in this implementation guide until officially released by Swissmedic

Swissmedic Location Identifier

Temporary NamingSystem in this implementation guide until officially released by Swissmedic

Example: Example Instances

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

123456002

Comprehensive Sample Combipack: Example of a RegulatedAuthorization (Marketing Authorization)

12345601

Comprehensive Sample Combipack: Example of a RegulatedAuthorization (Marketing Authorization)

67211001

Xospata 40 mg, Filmtabletten: Example of a RegulatedAuthorization (Marketing Authorization)

6721101

Xospata 40 mg, Filmtabletten: Example of a RegulatedAuthorization (Marketing Authorization)

68291001

Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

68291002

Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

6829103

Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

6829104

Padcev 30 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

CH-56891003

Comprehensive Sample Combipack: Example of a PackagedProductDefinition (Packaged Medicinal Product)

CH-56891003

Xospata 40 mg, Filmtabletten: Example of a PackagedProductDefinition (Packaged Medicinal Product)

CH-68291001

Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung: Example of a PackagedProductDefinition (Packaged Medicinal Product)

CH-68291002

Padcev 30 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung: Example of a PackagedProductDefinition (Packaged Medicinal Product)

Comprehensive Sample Combipack 20 mg Vaginal Salbe und 100 mg Vaginaltabletten

Comprehensive Sample Combipack: Example of a MedicinalProductDefinition (Medicinal Product)

Comprehensive Sample Product, Creme and Pessary (Bundle)

Comprehensive Beispiel Produkt, Creme und Vaginalzäpfchen: Example of a Bundle

Indication 10004055

Comprehensive Sample Combipack 20 mg Vaginal Salbe und 100 mg Vaginaltabletten: Example of a ClinicalUseDefinition (Indication)

Indication 10046950

Comprehensive Sample Combipack 20 mg Vaginal Salbe und 100 mg Vaginaltabletten: Example of a ClinicalUseDefinition (Indication)

Indication 10046961

Comprehensive Sample Combipack 20 mg Vaginal Salbe und 100 mg Vaginaltabletten: Example of a ClinicalUseDefinition (Indication)

Indication 10050348

Comprehensive Sample Combipack 20 mg Vaginal Salbe und 100 mg Vaginaltabletten: Example of a ClinicalUseDefinition (Indication)

Indication 10057352

Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung (Indication)

Indication 10059034

Xospata 40 mg, Filmtabletten: Example of a ClinicalUseDefinition (Indication)

Indication 10060558

Xospata 40 mg, Filmtabletten: Example of a ClinicalUseDefinition (Indication)

Indication 10081513

Xospata 40 mg, Filmtabletten: Example of a ClinicalUseDefinition (Indication)

Indication 10081514

Xospata 40 mg, Filmtabletten: Example of a ClinicalUseDefinition (Indication)

Indication 10084619

Xospata 40 mg, Filmtabletten: Example of a ClinicalUseDefinition (Indication)

Indication IND-10079528

Comprehensive Sample Combipack 20 mg Vaginal Salbe und 100 mg Vaginaltabletten: Example of a ClinicalUseDefinition (Indication)

MI Clindamycin-100-Pessary

Manufactured Item definition for Clindamycin 100 Vaginal Pessary

MI Clindamycin-20-Cream

Manufactured Item definition for Clindamycin 20 Vaginal Cream

MI Enfortumabum-vedotinum-20-Powder

Manufactured Item definition for Enfortumabum Vedotinum 20 mg, Lyophilisate for solution for infusion

MI Enfortumabum-vedotinum-30-Powder

Manufactured Item definition for Enfortumabum Vedotinum 30 mg, Lyophilisate for solution for infusion

MI Gilteritinibi-hemifumaras-40-Tablet

Manufactured Item definition for Gilteritinibi Hemifumaras 40 mg, Film-coated tablet

PHP Enfortumabum-vedotinum-30-Solution

Padcev 30 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung: Example of an AdministrableProductDefinition (Pharmaceutical Product)

Padcev 20 mg, Pulver Information for healthcare professionals

Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung: Example of a DocumentReference

Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung: Example of a MedicinalProductDefinition (Medicinal Product)

Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung (Bundle)

Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung: Example of a Bundle

Padcev 30 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

Padcev 30 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung: Example of a MedicinalProductDefinition (Medicinal Product)

Padcev 30 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung (Bundle)

Padcev 30 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung: Example of a Bundle

Patient Information Comprehensive-Sample-Combipack

Comprehensive-Sample-Combipack: Example of a DocumentReference

Patient Information Xospata, Filmtabletten

Xospata, Filmtabletten: Example of a DocumentReference

PhP Clindamycin-100-Pessary

Manufactured Item definition for Clindamycin 100 Vaginal Pessary (Pharmaceutical Product)

PhP Clindamycin-20-Vaginal Cream

Manufactured Item definition for Clindamycin 30 Vaginal Cream (Pharmaceutical Product)

PhP Enfortumabum-vedotinum-20-Solution

Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung: Example of an AdministrableProductDefinition (Pharmaceutical Product)

PhP Gilteritinibi-hemifumaras-40-Filmtabletten

Xospata 40 mg, Filmtabletten: Example of an AdministrableProductDefinition (Pharmaceutical Product)

Professional Information Comprehensive-Sample-Combipack

Comprehensive-Sample-Combipack: Example of a DocumentReference

Professional Information Xospata, Filmtabletten

Xospata, Filmtabletten: Example of a DocumentReference

Xospata 40 mg, Filmtabletten

Xospata 40 mg, Filmtabletten: Example of a MedicinalProductDefinition (Medicinal Product)

Xospata 40 mg, Filmtabletten (Bundle)

Xospata 40 mg, Filmtabletten: Example of a Bundle