Regulatory Pathways
218 pathways§21a AMG Compassionate Use – Germany
Compassionate use under §21a of the German Medicinal Products Act (AMG), authorised by BfArM for patients with serious or life-threatening diseases who cannot be adequately treated with authorised medicines.
Form: BfArM CU Application
15–45d medium30d§21a Arzneimittelgesetz (AMG)
AAP (Accès Précoce) – France
France's early access authorization (formerly ATU) allows patients to access promising medicines before marketing authorization. Managed by ANSM under the reformed 2021 system (Article L.5121-12 Code de la Santé Publique).
Form: ATU/AAP Application
>45d slow60dArticle L.5121-12 Code de la Santé Publique
Afghanistan MOH Special Import Authorization
Afghanistan Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Afghanistan Special Import Form
15–45d medium45dRegulated
Albania Compassionate Use Authorization
Albania regulatory authority compassionate use authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: Albania CU Application Form
15–45d medium30dRegulated
Algeria MOH Special Import Authorization
Algeria Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Algeria Special Import Form
15–45d medium45dRegulated
ALIMS BiH Compassionate Use – Bosnia and Herzegovina
Bosnia and Herzegovina Agency for Medicines and Medical Devices compassionate use authorization for unregistered medicines for patients with serious conditions.
Form: ALIMS BiH CU Application
15–45d medium30dLaw on Medicines and Medical Devices (BiH)
ALIMS Compassionate Use – Serbia
Serbia's Medicines and Medical Devices Agency (ALIMS) compassionate use authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: ALIMS CU Application
15–45d medium30dLaw on Medicines and Medical Devices (Serbia)
Andorra Special Import (via EMA framework)
Andorra special import authorization for unregistered medicines using the EMA/EU regulatory framework via neighboring EU country channels.
Form: Andorra Special Import Form
<15d fast14dVia EU/EMA regulatory framework
Angola MOH Special Import Authorization
Angola Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Angola Special Import Form
15–45d medium45dRegulated
ANMAT Emergency Authorization (Uso Compasivo) – Argentina
ANMAT emergency authorization for compassionate use of unapproved medicines for patients with serious or life-threatening conditions in Argentina.
Form: ANMAT Compassionate Use Form
15–45d medium30dLaw 16.463
Antigua and Barbuda MOH Special Import Authorization
Antigua and Barbuda Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Antigua and Barbuda Special Import Form
15–45d medium45dRegulated
ANVISA Expanded Access Program – Brazil
ANVISA's expanded access program allows use of unapproved drugs for patients with serious or life-threatening diseases who have no therapeutic alternatives among registered products.
Form: ANVISA EAP Petition
15–45d medium30dRDC 204/2017
Armenia MOH Special Import Authorization
Armenia Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Armenia Special Import Form
15–45d medium30dRegulated
Article 83 Compassionate Use – South Africa (SAHPRA)
Section 21 authorization allows for the sale of unregistered medicines in South Africa for compassionate use in individual patients or clinical trials. SAHPRA evaluates applications based on medical necessity and patient safety considerations.
Form: SAHPRA Section 21 Application Form
15–45d medium30dStatutory
Austria 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 Austria.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Azerbaijan MOH Special Import Authorization
Azerbaijan Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Azerbaijan Special Import Form
15–45d medium30dRegulated
Bahamas MOH Special Import Authorization
Bahamas Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Bahamas Special Import Form
15–45d medium45dRegulated
Barbados MOH Special Import Authorization
Barbados Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Barbados Special Import Form
15–45d medium30dRegulated
Belarus MOH Special Import Authorization
Belarus Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Belarus Special Import Form
15–45d medium30dRegulated
Belgium 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 Belgium.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Belize MOH Named Patient Authorization
Belize Ministry of Health named patient authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Belize Named Patient Form
15–45d medium45dRegulated
Benin MOH Special Import Authorization
Benin Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Benin Special Import Form
15–45d medium45dRegulated
Bhutan MOH Special Import Authorization
Bhutan Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Bhutan Special Import Form
15–45d medium45dRegulated
Bolivia MOH Special Import Authorization
Bolivia Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Bolivia Special Import Form
15–45d medium45dRegulated
BOMRA Compassionate Use Authorization – Botswana
Botswana Medicines Regulatory Authority compassionate use authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: BOMRA CU Form
15–45d medium21dDrugs and Related Substances Act
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