Regulatory Pathways
233 pathwaysSpain 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 Spain.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Special Access Programme (SAP) – Canada
Health Canada’s Special Access Programme permits authorized health care practitioners to request access to unauthorized drugs for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or are unavailable. Requests are reviewed on a case-by-case basis for urgent medical need.
Form: Special Access Programme request form / practitioner submission
Administrative
Special Access Scheme – Australia
Australia’s Special Access Scheme permits health practitioners to request access to an unapproved therapeutic good for a single patient on a case-by-case basis. Category A is generally used for seriously ill patients, while Category B requires TGA authorization before supply. [?]
Form: Special Access Scheme request / Category A notification or Category B application
Statutory/Administrative
Special Access Scheme – Australia (TGA)
The Therapeutic Goods Administration's Special Access Scheme (SAS) provides access to unapproved therapeutic goods for individual patients. Category A covers seriously ill patients, while Category B covers other cases where approved alternatives are unavailable or unsuitable.
Form: TGA Special Access Scheme Application Form (Category A or B)
<15d fast2dStatutory
Special Access Scheme (SAS) – Australia
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