Regulatory Pathways
218 pathwaysSao Tome and Principe MOH Special Import Authorization
Sao Tome and Principe Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Sao Tome and Principe Special Import Form
>45d slow60dRegulated
Saudi Arabia Special Access Program (SAP)
SFDA's special access pathway for unlicensed medicines for individual patients.
Form: SAP Form
15–45d medium21dRegulated
Senegal MOH Autorisation Exceptionnelle
Senegal Ministry of Health exceptional authorization for import of unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Senegal Exceptional Authorization Form
15–45d medium30dRegulated
Seychelles MOH Special Import Authorization
Seychelles Ministry of Health special import authorization for unregistered medicines for patients with serious medical conditions.
Form: Seychelles MOH Special Import Form
15–45d medium30dRegulated
SFDA Special Access Program (SAP) – Saudi Arabia
SFDA allows import of unregistered drugs for individual patients with serious unmet medical needs in Saudi Arabia, subject to physician request and SFDA approval.
Form: SFDA SAP Request Form
15–45d medium21dSFDA Drug Registration Rules
Sierra Leone MOH Special Import Authorization
Sierra Leone Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Sierra Leone Special Import Form
15–45d medium45dRegulated
Slovakia 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 Slovakia.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Slovenia 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 Slovenia.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
SMCU Compassionate Use Program – Ukraine
Ukraine State Medicinal Centres compassionate use program allowing access to unregistered medicines for patients with serious or life-threatening conditions.
Form: SMCU Compassionate Use Application
15–45d medium21dUkraine Drug Regulation Law
Solomon Islands MOH Special Import Authorization
Solomon Islands Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Solomon Islands Special Import Form
>45d slow60dRegulated
Somalia MOH Special Import Authorization
Somalia Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Somalia Special Import Form
>45d slow60dRegulated
South Sudan MOH Special Import Authorization
South Sudan Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH South Sudan Special Import Form
>45d slow60dRegulated
Spain 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 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