Regulatory Pathways
229 pathwaysRDB Pharmacy Special Access – Rwanda
Rwanda Development Board pharmacy division special access program for unregistered medicines for patients with serious or life-threatening conditions.
Form: RDB Pharmacy Special Access Form
<15d fast14dRwanda Pharmacy Law
Romania 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 Romania.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Roszdravnadzor Medical Use for Unregistered Drugs (Article 47) – Russia
Russian Federal Law No. 61-FZ on Medicines Circulation Article 47 allows use of unregistered medicinal products for individual patients with serious or life-threatening conditions under Ministry of Health permission.
Form: MOH Russia Application
15–45d medium30dFederal Law No. 61-FZ on Medicines Circulation
SAHPRA Section 21 Authorization – South Africa
SAHPRA Section 21 of the Medicines and Related Substances Act allows use of unregistered medicines when no suitable registered alternative exists, for named patients or in defined settings.
Form: SAHPRA Section 21 Application
15–45d medium30dMedicines Act Section 21
Saint Kitts and Nevis MOH Special Import Authorization
Saint Kitts and Nevis Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Saint Kitts and Nevis Special Import Form
15–45d medium45dRegulated
Saint Lucia MOH Special Import Authorization
Saint Lucia Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Saint Lucia Special Import Form
15–45d medium45dRegulated
Saint Vincent and the Grenadines MOH Special Import Authorization
Saint Vincent and the Grenadines Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Saint Vincent and the Grenadines Special Import Form
15–45d medium45dRegulated
Samoa MOH Special Import Authorization
Samoa Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Samoa Special Import Form
>45d slow60dRegulated
San Marino Special Import (via EMA framework)
San Marino special import authorization for unregistered medicines using the EMA/EU regulatory framework via neighboring EU country channels.
Form: San Marino Special Import Form
<15d fast14dVia EU/EMA regulatory framework
Sao 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 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