Country Specific Nomenclature for Expanded Access Programs · Obat Jalur Khusus) - for clinical...

Extension of the Global Clinical Supplies Group

Country Specific Nomenclature for Expanded Access

ProgramsUpdated March 2019


Country Supports Individual Patient Requests

Name of program/Type of national procedure

Support Expanded Access as a

Group/Cohort


Algeria Yes Not Available No Not Applicable

Argentina Yes10874/2017: Request of drug

importation under exception access program

No Not Applicable

Australia Yes Special Access Scheme Yes Clinical Trial

Austria Yes Heilversuch ("Named Patient Use") Yes Compassionate Use Program (CUP)

Belarus No Not applicable No Not Applicable

Belgium Yes Early Temporary Access — Medical Need Program (MNP)

Yes Early Temporary Access — Compassionate Use Program (CUP)

Brazil Yes Compassionate Use Yes Programa de Acesso Expandido

Bulgaria Yes Named Patient Yes Not Available

Canada Yes Special Access Program (SAP) Yes Special Access Program (SAP)

Chile Yes Provisional Use Authorization for Medicines

No Not Applicable

China YesUnapproved Drug Use: (The Drug Administration Law of the People's

Republic of China, 2015-04-24)No Not Applicable

Colombia Yes Vital Unavailable Medicine (Medicamento Vital No Disponible)

Yes Vital Unavailable Medicine (Medicamento Vital No Disponible)

Costa Rica Yes Acquisition and Import of Non Registered Medicines

No Not Applicable

Croatia Yes Individual Treatement Yes Compassionate Use of Drugs (milosrdno davanje lijeka)

Czech Republic Yes Use of an unregistered medicinal product

Yes Specific Therapeutic Programme (SpTP)

Nomenclature

CountrySupports Individual Patient RequestsName of program/Type of national procedureSupport Expanded Access as a Group/CohortName of program/Type of national procedure

Algeria YesNot AvailableNoNot Applicable

Argentina Yes10874/2017: Request of drug importation under exception access program NoNot Applicable

Australia YesSpecial Access SchemeYesClinical Trial

Austria YesHeilversuch ("Named Patient Use")YesCompassionate Use Program (CUP)

Belarus NoNot applicable NoNot Applicable

Belgium YesEarly Temporary Access — Medical Need Program (MNP)YesEarly Temporary Access — Compassionate Use Program (CUP)

Brazil YesCompassionate UseYesPrograma de Acesso Expandido

Bulgaria YesNamed Patient YesNot Available

Canada YesSpecial Access Program (SAP)YesSpecial Access Program (SAP)

Chile YesProvisional Use Authorization for MedicinesNoNot Applicable

China YesUnapproved Drug Use: (The Drug Administration Law of the People's Republic of China, 2015-04-24)NoNot Applicable

Colombia YesVital Unavailable Medicine (Medicamento Vital No Disponible)YesVital Unavailable Medicine (Medicamento Vital No Disponible)

Costa Rica YesAcquisition and Import of Non Registered MedicinesNoNot Applicable

Croatia YesIndividual TreatementYesCompassionate Use of Drugs (milosrdno davanje lijeka)

Czech Republic YesUse of an unregistered medicinal productYesSpecific Therapeutic Programme (SpTP)

Denmark YesCompassionate UseYesCompassionate Use

Ecuador YesExceptional Importation AuthorizationYesAcquisition of Medicines Not Listed in the National Schedule of Basic Medicines (CNMB)

Egypt YesNamed Patient SupplyNoNot Applicable

Estonia YesIn Estonia, the Compassionate Use Programs (CUP) follow the EU legislation: Regulation (EC) No 726/2004, Art. 83 result in the national procedure as physician initiates import for named patient use. The State Agency of Medicines reviews the programs from patient safety point and makes sure the supply is ensured until the need of the patient persists.YesUnapproved Drug Use or Compassionate Use

Finland YesSpecial permission for compassionate use. Individual PatientYesSpecial permission for compassionate use. Institutional permission

France YesNominative Temporary Use Authorization (Nominative ATU = nATU)YesCohort Temporary Use Authorization (Cohort ATU = cATU)

Georgia YesCompassionate UseYesNot Available

Germany YesNamed patient importYes Hardship Case Program (AMHV)

Ghana YesNamed Patient Use (No specific name is determined)YesAs this would be an extension to a clinical trial protocol — the name would be reflected in the title of the extended use protocol

Greece YesIndividual early access programYesCohort Expanded Access Program

Guatemala YesFinal User ImportationNoNot Applicable

Hong Kong YesNamed Patient ProgramYesExpanded Access Program

Hungary YesCompassionate Use of Medicinal ProductsYesProvisional and special marketing

India YesImport of drugs for personal useNoNot Applicable

IndonesiaYesSpecial Access Scheme (Pemasukan Obat Jalur Khusus) - for special therapeutic purposeYesSpecial Access Scheme (Pemasukan Obat Jalur Khusus) - for clinical test purpose

Ireland Yes"Specials" to supply of unlicensed medicinal productsYesNot Available

Israel YesUrgent Care/Single Patient Access YesCompassionate Care

Italy YesUso terapeutico nominale di medicinale sottoposto a sperimentazione clinicaYesUso Terapeutico/Uso Compassionevole/Expanded Access/Named Patient program

Japan NoNot Applicable YesExtension trial (Clinical Trials Conducted on Ethical Grounds)

KazakhstanYesClinical Trial (Phase IV or Special Assignment).YesClinical Trial (Phase IV or Special Assignment).

Kenya YesNamed Patient UseYesExtended Access Program

KuwaitYesNot AvailableNoNot Applicable

Latvia YesNot AvailableYesNot Available

Lebanon YesCompassionate UseNoNot Applicable

Lithuania YesUnregistered medicinal products (Vardinių vaistinių preparatų įsigijimo taisyklės)YesNot Available

Macedonia NoNot Applicable NoNot Applicable

Malaysia YesNamed-Patient NoNot Applicable

Malta YesCompassionate Use/Unlicensed Medicinal ProductYes“Group of patients” can be interpreted as any set (i.e. more than one) of individual patients that would benefit from a treatment for a specific condition. The terms “cohort”, “collective use”, “patient group prescription” or “special treatment programme” used in some MSs (Member State), in accordance with national legislations, may correspond with this concept.

Mexico YesImport Authorization of Drug Products for treatment, prevention or rehabilitation of diseases (for personal use)YesOfficial Recognition of Orphan Drug

Moldova NoNot Applicable NoNot Applicable

Morocco YesSpecial Access of Non-Registered ProductsNoNot Applicable

Netherlands YesNamed Patient Product / Named Patient ProgrammeYesCompassionate use program

New Zealand YesSpecial Access SchemeYesSpecial Access Scheme

Nigeria YesNo name allocated to these programsYesIf the access is via a protocol, the protocol title will be the identifier

Norway YesNamed Patient ProgramYesCompassionate Use Program

Oman NoNot Applicable NoNot Applicable

PakistanYesNot AvailableNoNot Applicable

Panama YesNo specific programNoNot Applicable

Peru YesExceptional Importation AuthorizationYesNot Available

Philippines YesCompassionate Special Permit (CSP)YesCompassionate Special Permit (CSP)

Poland YesNamed Patient ProgramNoNot Applicable

Portugal YesExceptional use authorization (AUE = Autorização de Utilização Excecional)YesEarly Access Program (EAP) to medicinal products without MA; Previous Access Program to medicinal products without HTA assessment concluded

Romania YesUnapproved Medicinal Products / Compassionate UseYesUnapproved Medicinal Products / Compassionate Use

Russia Yes"Named patient supply under vital indications"Yes Not defined in regulation

Saudi Arabia YesUnregistered/Non-prohibited/Compassionate UseNoNot Applicable

Serbia YesPatient name use for single patientYesNot Available

Singapore YesSpecial access scheme / Named patient basis / Exemption drug accessYesThis will be treated and regulated under a clinical trial application process either under a clinical trial protocol or cEAP protocol

Slovakia YesTherapeutical use of unauthorized medicinal product for individual patient (Terapeutické použitie neregistrovaného lieku pre jedného pacienta)YesTherapeutical use of unauthorized medicinal product for group of patients (Terapeutické použitie neregistrovaného lieku pre skupinu pacientov)

Slovenia YesUnapproved Drug Use YesUnapproved Drug Use / Submission for approval of a clinical trial

South Africa YesNamed Patient UseYesExtended Access clinical trial

South Korea YesNamed Patient Use (Self Treatment)YesTreatment use of an investigational new drug or Emergency use of an investigational new drug

Spain YesCompassionate Use of Medicinal Products under InvestigationYesTemporary authorisation of use

Sri Lanka YesEmergency and other special circumstancesNoNot Applicable

Sweden YesSpecial Permission/Special LicenseYesCompassionate Use Programme (CUP)

Switzerland YesSwissmedic Special Authorisation for Importation (Sonderbewilligung)YesSwissmedic Special Authorisation for Importation (Sonderbewilligung)

Taiwan YesCompassionate UseYesExpanded Access Program

Thailand YesPatient Use ProgramNoNot Applicable

Tunisia YesCompassionate Use/Named Patient SupplyNoNot Applicable

Turkey YesCompassionate Use program (CUP)YesContinued Access (Erken Erişim)

Ukraine YesNot AvailableNoNot Applicable

United Arab Emirates YesNot AvailableNoNot Applicable

United Kingdom YesSupply of unlicensed medicinal products (“specials”)YesCompassionate Use and Expanded Access Programmes.

United States YesExpanded Access (Compassionate Use)YesExpanded Access (Compassionate Use)

Uruguay YesMedicines and medical devices not registered in uruguayNoNot Applicable

Venezuela Yes"MEDICAMENTOS DE SERVICIO"Yes"MEDICAMENTOS DE SERVICIO"

Last Update March 2019





Group/Cohort


Denmark Yes Compassionate Use Yes Compassionate Use

Ecuador Yes Exceptional Importation Authorization

YesAcquisition of Medicines Not Listed in

the National Schedule of Basic Medicines (CNMB)

Egypt Yes Named Patient Supply No Not Applicable

Estonia Yes

In Estonia, the Compassionate Use Programs (CUP) follow the EU legislation: Regulation (EC) No 726/2004, Art. 83 result in the national procedure as physician

initiates import for named patient use. The State Agency of Medicines reviews the programs from patient

safety point and makes sure the supply is ensured until the need of the

patient persists.

Yes Unapproved Drug Use or Compassionate Use

Finland Yes Special permission for compassionate use. Individual Patient

Yes Special permission for compassionate use. Institutional permission

France YesNominative Temporary Use

Authorization (Nominative ATU = nATU)

Yes Cohort Temporary Use Authorization (Cohort ATU = cATU)

Georgia Yes Compassionate Use Yes Not Available

Germany Yes Named patient import Yes Hardship Case Program (AMHV)

Ghana Yes Named Patient Use (No specific name is determined)

Yes

As this would be an extension to a clinical trial protocol — the name

would be reflected in the title of the extended use protocol

Greece Yes Individual early access program Yes Cohort Expanded Access Program

Guatemala Yes Final User Importation No Not Applicable

Hong Kong Yes Named Patient Program Yes Expanded Access Program

Hungary Yes Compassionate Use of Medicinal Products

Yes Provisional and special marketing

India Yes Import of drugs for personal use No Not Applicable

Indonesia YesSpecial Access Scheme (Pemasukan

Obat Jalur Khusus) - for special therapeutic purpose

YesSpecial Access Scheme (Pemasukan Obat Jalur Khusus) - for clinical test

purpose

Ireland Yes "Specials" to supply of unlicensed medicinal products

Yes Not Available

Nomenclature























































































Group/Cohort


Israel Yes Urgent Care/Single Patient Access Yes Compassionate Care

Italy YesUso terapeutico nominale di

medicinale sottoposto a sperimentazione clinica

YesUso Terapeutico/Uso

Compassionevole/Expanded Access/Named Patient program

Japan No Not Applicable Yes Extension trial (Clinical Trials Conducted on Ethical Grounds)

Kazakhstan YesClinical Trial (Phase IV or Special

Assignment). YesClinical Trial (Phase IV or Special

Assignment).

Kenya Yes Named Patient Use Yes Extended Access Program

Kuwait Yes Not Available No Not Applicable

Latvia Yes Not Available Yes Not Available

Lebanon Yes Compassionate Use No Not Applicable

Lithuania YesUnregistered medicinal products

(Vardinių vaistinių preparatų įsigijimo taisyklės)

Yes Not Available

Macedonia No Not Applicable No Not Applicable

Malaysia Yes Named-Patient No Not Applicable

Malta Yes Compassionate Use/Unlicensed Medicinal Product

Yes

“Group of patients” can be interpreted as any set (i.e. more than one) of individual

patients that would benefit from a treatment for a specific condition. The

terms “cohort”, “collective use”, “patient group prescription” or “special

treatment programme” used in some MSs (Member State), in accordance with

national legislations, may correspond with this concept.

Mexico Yes

Import Authorization of Drug Products for treatment, prevention or

rehabilitation of diseases (for personal use)

Yes Official Recognition of Orphan Drug

Moldova No Not Applicable No Not Applicable

Morocco Yes Special Access of Non-Registered Products

No Not Applicable

Netherlands Yes Named Patient Product / Named Patient Programme

Yes Compassionate use program

New Zealand Yes Special Access Scheme Yes Special Access Scheme

Nomenclature























































































Group/Cohort


Nigeria Yes No name allocated to these programs Yes If the access is via a protocol, the protocol title will be the identifier

Norway Yes Named Patient Program Yes Compassionate Use Program

Oman No Not Applicable No Not Applicable

Pakistan Yes Not Available No Not Applicable

Panama Yes No specific program No Not Applicable

Peru Yes Exceptional Importation Authorization

Yes Not Available

Philippines Yes Compassionate Special Permit (CSP) Yes Compassionate Special Permit (CSP)

Poland Yes Named Patient Program No Not Applicable

Portugal YesExceptional use authorization (AUE

= Autorização de Utilização Excecional)

Yes

Early Access Program (EAP) to medicinal products without MA;

Previous Access Program to medicinal products without HTA assessment

concluded

Romania Yes Unapproved Medicinal Products / Compassionate Use

Yes Unapproved Medicinal Products / Compassionate Use

Russia Yes"Named patient supply under vital

indications" Yes Not defined in regulation

Saudi Arabia YesUnregistered/Non-

prohibited/Compassionate Use No Not Applicable

Serbia Yes Patient name use for single patient Yes Not Available

Singapore YesSpecial access scheme / Named

patient basis / Exemption drug access Yes

This will be treated and regulated under a clinical trial application process either under a clinical trial protocol or cEAP

protocol

Slovakia Yes

Therapeutical use of unauthorized medicinal product for individual patient (Terapeutické použitie

neregistrovaného lieku pre jedného pacienta)

Yes

Therapeutical use of unauthorized medicinal product for group of patients (Terapeutické použitie neregistrovaného

lieku pre skupinu pacientov)

Slovenia Yes Unapproved Drug Use YesUnapproved Drug Use / Submission for

approval of a clinical trial

South Africa Yes Named Patient Use Yes Extended Access clinical trial

Nomenclature























































































Group/Cohort


South Korea Yes Named Patient Use (Self Treatment) YesTreatment use of an investigational new

drug or Emergency use of an investigational new drug

Spain Yes Compassionate Use of Medicinal Products under Investigation

Yes Temporary authorisation of use

Sri Lanka Yes Emergency and other special circumstances

No Not Applicable

Sweden Yes Special Permission/Special License Yes Compassionate Use Programme (CUP)

Switzerland Yes Swissmedic Special Authorisation for Importation (Sonderbewilligung)

Yes Swissmedic Special Authorisation for Importation (Sonderbewilligung)

Taiwan Yes Compassionate Use Yes Expanded Access Program

Thailand Yes Patient Use Program No Not Applicable

Tunisia Yes Compassionate Use/Named Patient Supply

No Not Applicable

Turkey Yes Compassionate Use program (CUP) Yes Continued Access (Erken Erişim)

Ukraine Yes Not Available No Not Applicable

United Arab Emirates Yes Not Available No Not Applicable

United Kingdom YesSupply of unlicensed medicinal

products (“specials”) YesCompassionate Use and Expanded

Access Programmes.

United States Yes Expanded Access (Compassionate Use)

Yes Expanded Access (Compassionate Use)

Uruguay Yes Medicines and medical devices not registered in uruguay

No Not Applicable

Venezuela Yes "MEDICAMENTOS DE SERVICIO" Yes "MEDICAMENTOS DE SERVICIO"

Nomenclature



















































































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