Regulatory Pathways — Named Patient, Compassionate Use & Early Access

Finland 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 Finland.

Form: National compassionate use form

15–45d medium30dRegulated under EU Directive 2001/83/EC

France 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 France.

Form: National compassionate use form

15–45d medium30dRegulated under EU Directive 2001/83/EC

Gabon MOH Special Import Authorization

Gabon Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Gabon Special Import Form

15–45d medium45dRegulated

Gambia MOH Special Import Authorization

Gambia Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Gambia Special Import Form

15–45d medium45dRegulated

Georgia MOH Special Import Authorization

Georgia Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Georgia Special Import Form

15–45d medium30dRegulated

Germany 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 Germany.

Form: National compassionate use form

15–45d medium30dRegulated under EU Directive 2001/83/EC

Greece 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 Greece.

Form: National compassionate use form

15–45d medium30dRegulated under EU Directive 2001/83/EC

Grenada MOH Special Import Authorization

Grenada Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Grenada Special Import Form

15–45d medium45dRegulated

Guatemala MOH Named Patient Authorization

Guatemala Ministry of Health named patient authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Guatemala Named Patient Form

15–45d medium30dRegulated

Guinea MOH Special Import Authorization

Guinea Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Guinea Special Import Form

15–45d medium45dRegulated

Guinea-Bissau MOH Special Import Authorization

Guinea-Bissau Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Guinea-Bissau Special Import Form

15–45d medium45dRegulated

Guyana MOH Special Import Authorization

Guyana Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Guyana Special Import Form

15–45d medium45dRegulated

Haiti MOH Special Import Authorization

Haiti Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Haiti Special Import Form

15–45d medium45dRegulated

Health Canada Special Access Program (SAP)

Health Canada's SAP allows manufacturers to sell drugs not approved in Canada to practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable.

Form: HC/SC 3011 SAP Request Form

<15d fast5dSection C.08.010 Food and Drug Regulations

Honduras MOH Named Patient Authorization

Honduras Ministry of Health named patient authorization for unregistered medicines for patients with serious or life-threatening conditions.

Form: MOH Honduras Named Patient Form

15–45d medium45dRegulated

HSA Special Access Route (SAR) – Singapore

Singapore's Health Sciences Authority allows access to unregistered therapeutic products via the Special Access Route for individual patients with serious medical conditions, subject to physician application.

Form: HSA SAR Application Form

<15d fast7dHealth Products Act

Hungary 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 Hungary.

Form: National compassionate use form

15–45d medium30dRegulated under EU Directive 2001/83/EC

Iceland 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 Iceland.

Form: National compassionate use form

15–45d medium30dRegulated under EU Directive 2001/83/EC

India Named Patient Import (Form 12B)

Under India's New Drugs and Clinical Trials Rules 2019, a named patient can import unapproved drugs...

Form: Form 12B

15–45d medium30dRegulated

INVIMA Special Import for Unregistered Drugs – Colombia

INVIMA special import authorization allowing physicians to import unregistered medicines for named patients with serious conditions in Colombia.

Form: INVIMA Special Import Form

15–45d medium21dDecreto 677 de 1995

Iran MOH Special Import Authorization

Iran Food and Drug Administration special import authorization for access to medicines not registered in Iran for patients with serious or life-threatening conditions.

Form: IFDA Special Import Form

15–45d medium45dIran Food and Drug Act

Iraqi MOH Exceptional Import Authorization

Iraq Ministry of Health exceptional import program allowing access to unregistered medicines for patients with serious conditions not treatable with locally available products.

Form: MOH Iraq Import Permission

15–45d medium45dIraqi Drug Regulation

Ireland 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 Ireland.

Form: National compassionate use form

15–45d medium30dRegulated under EU Directive 2001/83/EC

ISP Provisional Authorization for Unregistered Products – Chile

Chile's ISP provisional authorization allowing import and use of unregistered medicinal products for patients with serious medical needs.

Form: ISP Provisional Authorization Form

15–45d medium30dHealth Code Article 100

Israeli MOH Compassionate Use (Section 27) – Israel

Israel allows compassionate use of unapproved drugs under Section 27 of the Pharmacists Ordinance for patients with serious or life-threatening conditions who have exhausted approved treatment options.

Form: MOH Israel CU Application

15–45d medium30dPharmacists Ordinance Section 27