Regulatory Pathways
218 pathwaysTITCK 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
Vanuatu MOH Special Import Authorization
Vanuatu Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Vanuatu Special Import Form
>45d slow60dRegulated
Venezuela MOH Special Import Authorization
Venezuela Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Venezuela Special Import Form
15–45d medium45dRegulated
Yemen MOH Special Import Authorization
Yemen Ministry of Health special import authorization for access to medicines not registered in Yemen for patients with serious medical conditions.
Form: MOH Yemen Special Import Form
15–45d medium45dYemen Drug Regulations
ZAMRA Special Import Permit – Zambia
Zambia Medicines Regulatory Authority special import permit for unregistered medicines for patients with serious or life-threatening conditions.
Form: ZAMRA Special Import Form
15–45d medium30dMedicines and Allied Substances Act
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