CH EPL (R5)
0.1.0 - ci-build

CH EPL (R5), published by Federal Office of Public Health FOPH. 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/bag-epl/bag-epl-fhir/ 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.

Structures: Resource Profiles

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

CH EPL Organization

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

CH IDMP AdministrableProductDefinition

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

CH IDMP ClinicalUseDefinition Indication

Profile of the ClinicalUseDefinition resource for representing an indication.

CH IDMP DocumentReference

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

CH IDMP ManufacturedItemDefinition

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

IDMP Bundle

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

IDMP Ingredient

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

IDMP MedicinalProductDefinition

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

IDMP PackagedProductDefinition

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

IDMP 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.

FOPH Dossier Number

Identifier holding the Dossier number of FOPH

GLN Identifier

Identifier holding a number for GLN (Global Location Number)

LOC Identifier

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

Structures: Extension Definitions

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

CH - EPL Full Limitation Text

Extension for representing the full wording of the limitations used by FOPH

CH - EPL Product Price

A set of information about the price of a drug

CH - EPL Regulated Authorization Limitation

A limitation to an authorisation for reimbursement of a drug, for a certain indication.

CH - EPL Reimbursement SL

A set of information about the reimbursement of a drug

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 EPL - Gamme

Value Set for the Gamme from ePL used by FOPH

CH EPL - Limitation Status

Value Set for Limitierungsstatus from ePL used by FOPH

CH EPL - Listing Status

Value Set for Listing Status from ePL used by FOPH

CH EPL - Other Characteristics Packaged Item

Value Set for Other Characteristics of a Packaged Item from ePL used by FOPH

CH EPL - Price Type

Value Set for Pricetype from ePL used by FOPH

CH EPL - Product Type

Value Set for the Product Type from ePL used by FOPH

CH EPL - Reimbursement Status

Value Set for Reimbursement Status from ePL used by FOPH

CH EPL - Type of Price Change

Value Set for TypeofPriceChange from ePL used by FOPH

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 - 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

CH SMC - TherapeuticProductcode

Value Set for the TherapeuticProductcode from SMC

CH SMC- Additional Monitoring Indicator

Value Set for the Additional Monitoring Indicator 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 EPL - Gamme

CH ePL - Code System for the Gamme from ePL used by FOPH

CH EPL - Limitation Status

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

CH EPL - Listing Status

CH ePL - Standard Terms used in Switzerland (aggregations of codes of ValueSets Listungs Status

CH EPL - Other Characteristics Packaged Item

CH ePL - Standard Terms used in Switzerland (aggregations of codes of ValueSets Other Characteristics of a Packaged Item

CH EPL - Price Type

CH ePL - Standard Terms used in Switzerland (aggregations of codes of ValueSets Price Type

CH EPL - Product Type

Code System for the Product Type from ePL used by FOPH

CH EPL - Reimbursement Status

CH ePL - Standard Terms used in Switzerland (aggregations of codes of ValueSets Vergütungs Status

CH EPL - Type of Price Change

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

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 - 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)

CH SMC - TherapeuticProductcode

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

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)

Example: Example Instances

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

5204201

ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk

52042011

ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk

5470402

ESTALIS Matrixpfl 50/250 24 Stk

54704089

ESTALIS Matrixpfl 50/250 24 Stk

66231001

KEYTRUDA Inf Konz 100 mg / 4 ml

6623101

KEYTRUDA Inf Konz 100 mg / 4 ml

67431001

TRIOGEN Kaps 250 mg Ds 100 Stk

6743101

TRIOGEN Kaps 250 mg Ds 100 Stk

67719001

CUPRIOR Filmtabl 150 mg 72 Stk

6771901

CUPRIOR Filmtabl 150 mg 72 Stk

68793001

PAXLOVID Filmtabl 4x150mg/2x100mg

6879301

PAXLOVID Filmtabl 4x150mg/2x100mg

CH-52042011

ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk: Example of a PackagedProductDefinition (Packaged Medicinal Product)

CH-54704089

ESTALIS Matrixpfl 50/250 24 Stk: Example of a PackagedProductDefinition (Packaged Medicinal Product)

CH-66231001

KEYTRUDA Inf Konz 100 mg / 4 ml: Example of a PackagedProductDefinition (Packaged Medicinal Product)

CH-67431001

TRIOGEN Kaps 250 mg Ds 100 Stk: Example of a PackagedProductDefinition (Packaged Medicinal Product)

CH-68291001

CUPRIOR Filmtabl 150 mg 72 Stk: Example of a PackagedProductDefinition (Packaged Medicinal Product)

CH-68793001

PAXLOVID Filmtabl 4x150mg/2x100mg: Example of a PackagedProductDefinition (Packaged Medicinal Product)

CUPRIOR Filmtabl 150 mg 72 Stk

CUPRIOR Filmtabl 150 mg 72 Stk: Example of a MedicinalProductDefinition (Medicinal Product)

CUPRIOR Filmtabl 150 mg 72 Stk (Bundle)

CUPRIOR Filmtabl 150 mg 72 Stk: Example of a Bundle

Cuprior, Filmtabletten Fachinformation

CUPRIOR Filmtabl 150 mg 72 Stk

Cuprior, Filmtabletten Patienteninformation

CUPRIOR Filmtabl 150 mg 72 Stk

ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk

ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk: Example of a MedicinalProductDefinition (Medicinal Product)

ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk (Bundle)

ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk: Example of a Bundle

ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk Fachinformation

ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk

ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk Patienteninformation

ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk

ESTALIS Matrixpfl 50/250 24 Stk

ESTALIS Matrixpfl 50/250 24 Stk: Example of a MedicinalProductDefinition (Medicinal Product)

ESTALIS Matrixpfl 50/250 24 Stk (Bundle)

ESTALIS Matrixpfl 50/250 24 Stk: Example of a Bundle

ESTALIS Matrixpfl 50/250 24 Stk Fachinformation

ESTALIS Matrixpfl 50/250 24 Stk

ESTALIS Matrixpfl 50/250 24 Stk Patienteninformation

ESTALIS Matrixpfl 50/250 24 Stk

Indication 10009900

ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk: Example of an ClinicalParticulars-Indication (Indication)

Indication 10019927

KEYTRUDA Inf Konz 100 mg / 4 ml: Example of an ClinicalParticulars-Indication (Indication)

Indication 10021782

KEYTRUDA Inf Konz 100 mg / 4 ml: Example of an ClinicalParticulars-Indication (Indication)

Indication 10027400

KEYTRUDA Inf Konz 100 mg / 4 ml: Example of an ClinicalParticulars-Indication (Indication)

Indication 10028881

KEYTRUDA Inf Konz 100 mg / 4 ml: Example of an ClinicalParticulars-Indication (Indication)

Indication 10030247

ESTALIS Matrixpfl 50/250 24 Stk: Example of an ClinicalParticulars-Indication (Indication)

Indication 10031285

ESTALIS Matrixpfl 50/250 24 Stk: Example of an ClinicalParticulars-Indication (Indication)

Indication 10043971

KEYTRUDA Inf Konz 100 mg / 4 ml: Example of an ClinicalParticulars-Indication (Indication)

Indication 10061091

CUPRIOR Filmtabl 150 mg 72 Stk: Example of an ClinicalParticulars-Indication (Indication) and TRIOGEN Kaps 250 mg Ds 100 Stk: Example of an ClinicalParticulars-Indication (Indication)

Indication 10075566

KEYTRUDA Inf Konz 100 mg / 4 ml: Example of an ClinicalParticulars-Indication (Indication)

Indication 10084529

PAXLOVID Filmtabl 4x150mg/2x100mg: Example of an ClinicalParticulars-Indication (Indication)

KEYTRUDA Inf Konz 100 mg / 4 ml

KEYTRUDA Inf Konz 100 mg / 4 ml: Example of a MedicinalProductDefinition (Medicinal Product)

KEYTRUDA Inf Konz 100 mg / 4 ml (Bundle)

KEYTRUDA Inf Konz 100 mg / 4 ml: Example of a Bundle

Keytruda, Konzentrat zur Herstellung einer Infusionslösung Fachinformation

KEYTRUDA Inf Konz 100 mg / 4 ml

Limitation 254837009

PAXLOVID Filmtabl 4x150mg/2x100mg: Example of an ClinicalUseDefinition-Limitation (Indication)

Limitation 79886009

CUPRIOR Filmtabl 150 mg 72 Stk: Example of an ClinicalUseDefinition-Limitation (Indication)

Limitation 840539006

PAXLOVID Filmtabl 4x150mg/2x100mg: Example of an ClinicalUseDefinition-Limitation (Indication)

MI Budesonidum-2.3mg-Tablet

Manufactured Item definition for Budesonidum 2.3mg tablet

MI Estradiol-hemihydrate-Norethisteroni-acetas-Transdermal-patch

Manufactured Item definition for Estradiol-hemihydrate-and-Norethisteroni-acetas-Transdermal-patch

MI Nirmatrelvir-150mg-Tablet

Manufactured Item definition for Nirmatrelvir 150mg Filmcoatedtablet

MI Pembrolizumab-100mg-Vial

Manufactured Item definition for KEYTRUDA Inf Konz 100 mg / 4 ml

MI Ritonavirum-100mg-Tablet

Manufactured Item definition for Ritonavirum 100mg Filmcoatedtablet

MI Solvent

Manufactured Item definition for solvent

MI Trientinum-150mg-Tablet

Manufactured Item definition for Trientinum 150 mg Film-coated tablet

MI Trientinum-250mg-Capsule

Manufactured Item definition for Trientinum 250 mg Capsule

PAXLOVID Filmtabl 4x150mg/2x100mg

PAXLOVID Filmtabl 4x150mg/2x100mg: Example of a MedicinalProductDefinition (Medicinal Product)

PAXLOVID Filmtabl 4x150mg/2x100mg (Bundle)

PAXLOVID Filmtabl 4x150mg/2x100mg: Example of a Bundle

Paxlovid, Filmtabletten Patienteninformation

PAXLOVID Filmtabl 4x150mg/2x100mg

PhP Budesonidum-Suspension

Administrable Product of Budesonidum Suspension

PhP Estradiol-hemihydrate and Norethisteroni-acetas Transdermal-patch

Administrable Product of Estradiol-hemihydrate and Norethisteroni-acetas Transdermal-patch

PhP Pembrolizumab-100mg-Vial

Administrable Product of KEYTRUDA Inf Konz 100 mg / 4 ml

PhP Trientinum-150mg-Tablet

Administrable Product of Trientinum 150mg Film-coated tablet

PhP Trientinum-150mg-Tablet

Administrable Product of Trientinum 150mg Film-coated tablet

PhP-Nirmatrelvir-150mg-Filmcoatedtablet

Administrable Product of Paxlovid-Filmcoatedtablet

PhP-Ritonavirum-100mg-Filmcoatedtablet

Administrable Product of Paxlovid-Filmcoatedtablet

Professional Information Paxlovid, Filmtabletten Fachinformation

PAXLOVID Filmtabl 4x150mg/2x100mg

Reimbursement SL 17418

ESTALIS Matrixpfl 50/250 24 Stk: Example of an Regulated Authorization - Reimbursement Authorization

Reimbursement SL 17973

ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk: Example of an Regulated Authorization - Reimbursement Authorization

Reimbursement SL 20416

KEYTRUDA Inf Konz 100 mg / 4 ml: Example of an Regulated Authorization - Reimbursement Authorization

Reimbursement SL 21070

TRIOGEN Kaps 250 mg Ds 100 Stk: Example of an Regulated Authorization - Reimbursement Authorization

Reimbursement SL 21208

CUPRIOR Filmtabl 150 mg 72 Stk: Example of an Regulated Authorization - Reimbursement Authorization

Reimbursement SL 21529

PAXLOVID Filmtabl 4x150mg/2x100mg: Example of an Regulated Authorization - Reimbursement Authorization

TRIOGEN Kaps 250 mg Ds 100 Stk

TRIOGEN Kaps 250 mg Ds 100 Stk: Example of a MedicinalProductDefinition (Medicinal Product)

TRIOGEN Kaps 250 mg Ds 100 Stk (Bundle)

TRIOGEN Kaps 250 mg Ds 100 Stk: Example of a Bundle

Triogen, Kapseln Fachinformation

TRIOGEN Kaps 250 mg Ds 100 Stk

Triogen, Kapseln Patienteninformation

TRIOGEN Kaps 250 mg Ds 100 Stk