Regulatory Pathways

229 pathways

TGA program enabling healthcare practitioners to access unapproved therapeutic goods for single patients on a case-by-case basis. Consists of Category A (seriously ill) and Category B (other cases).

Form: SAS Category B Application Form

<15d fast14dAdministrative

Sudan MOH Special Import Authorization

Sudan Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Sudan Special Import Form

15–45d medium45dRegulated

Suriname MOH Special Import Authorization

Suriname Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Suriname Special Import Form

15–45d medium45dRegulated

Sweden Compassionate Use (Article 83 EMA)

EMA Article 83 compassionate use framework allowing access to unauthorised medicinal products for groups of patients with a chronically or seriously debilitating or life-threatening disease in Sweden.

Form: National compassionate use form

15–45d medium30dRegulated under EU Directive 2001/83/EC

Swissmedic Compassionate Use – Switzerland

Swissmedic allows compassionate use of medicines not yet authorised in Switzerland for patients with serious or life-threatening diseases under the Therapeutic Products Act.

Form: Swissmedic Compassionate Use Application

15–45d medium30dTherapeutic Products Act (HMG/LPTh)

Syria MOH Special Import Authorization

Syria Ministry of Health special import authorization allowing access to unregistered medicines for patients with serious conditions.

Form: SFDP Special Import Form

15–45d medium45dSyrian Drug Regulations

Tajikistan MOH Special Import Authorization

Tajikistan Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Tajikistan Special Import Form

15–45d medium45dRegulated

TGA Authorised Prescriber Scheme – Australia

Allows medical practitioners to supply unapproved therapeutic goods to a class of patients with a particular medical condition without requiring individual TGA approvals for each patient.

Form: TGA Authorised Prescriber Application

>45d slow60dTherapeutic Goods Act 1989 Section 19

TGA PNG Special Access Scheme – Papua New Guinea

Papua New Guinea's Therapeutic Goods Administration special access scheme for unregistered medicines for patients with serious medical needs.

Form: TGA PNG Special Access Form

15–45d medium30dPapua New Guinea Drug Regulation

TGA Special Access Scheme – Category B (SAS-B)

TGA SAS Category B allows supply of unapproved therapeutic goods to individual patients on a case-by-case basis, with TGA approval required before supply.

Form: TGA SAS-B Notification/Approval Form

15–45d medium28dTherapeutic Goods Act 1989 Section 19

Timor-Leste MOH Special Import Authorization

Timor-Leste Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Timor-Leste Special Import Form

>45d slow60dRegulated

TITCK Compassionate Use Authorization – Turkey

Turkish Medicines and Medical Devices Agency (TITCK) allows compassionate use of unlicensed medicines for patients with serious or life-threatening conditions.

Form: TITCK Compassionate Use Application

15–45d medium21dLaw No. 1262 on Pharmaceuticals

TMDA Special Import Permit – Tanzania

Tanzania Medicines and Medical Devices Authority special import permit for unregistered medicines for patients with serious medical needs.

Form: TMDA Special Import Form

15–45d medium30dTanzania Food, Drugs and Cosmetics Act

Togo MOH Special Import Authorization

Togo Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Togo Special Import Form

15–45d medium45dRegulated

Tonga MOH Special Import Authorization

Tonga Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Tonga Special Import Form

>45d slow60dRegulated

Trinidad and Tobago MOH Special Import Authorization

Trinidad and Tobago Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Trinidad and Tobago Special Import Form

15–45d medium30dRegulated

Tunisia MOH Special Import Authorization

Tunisia Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Tunisia Special Import Form

15–45d medium45dRegulated

Turkmenistan MOH Special Import Authorization

Turkmenistan Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Turkmenistan Special Import Form

15–45d medium45dRegulated

Tuvalu MOH Special Import Authorization

Tuvalu Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Tuvalu Special Import Form

>45d slow60dRegulated

UAE Named Patient Program

MOHAP allows import of unregistered medicines for individual patients under physician supervision.

Form: MOHAP NPP Form

<15d fast14dRegulated

UK Early Access to Medicines Scheme (EAMS)

EAMS gives patients with life-threatening or seriously debilitating conditions access to medicines that don't yet have a marketing authorisation.

Form: EAMS Application

>45d slow90dRegulated

Uruguay MOH Special Import Authorization

Uruguay Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Uruguay Special Import Form

15–45d medium30dRegulated

Uso Compasivo – Spain (Real Decreto 1015/2009)

Spanish compassionate use framework under Royal Decree 1015/2009 allowing access to medicines under investigation or not marketed in Spain for patients with serious or life-threatening conditions.

Form: AEMPS Compassionate Use Form

15–45d medium30dReal Decreto 1015/2009

Uso Compassionevole – Italy (DM 7 settembre 2017)

Italian compassionate use under Ministerial Decree of 7 September 2017 for individual patients with serious, rare or life-threatening diseases.

Form: AIFA Compassionate Use Application

15–45d medium45dDecreto Ministeriale 7 settembre 2017

Uzbekistan MOH Special Import Authorization

Uzbekistan Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Uzbekistan Special Import Form

15–45d medium30dRegulated

Page 9 of 10 (229 total)

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