Regulatory Pathways
233 pathwaysLicensläkemedel (Licensed Medicine) – Sweden
Swedish licensed medicine system allowing Läkemedelsverket to grant licenses for unlicensed medicines for individual patients when no suitable licensed alternative exists.
Form: Läkemedelsverket License Application
<15d fast14dLäkemedelslagen (Swedish Medicinal Products Act)
Liechtenstein 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 Liechtenstein.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Lithuania 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 Lithuania.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Luxembourg 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 Luxembourg.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Madagascar MOH Special Import Authorization
Madagascar Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Madagascar Special Import Form
15–45d medium45dRegulated
Malawi MOH Special Import Authorization
Malawi Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Malawi Special Import Form
15–45d medium45dRegulated
Maldives MOH Special Import Authorization
Maldives Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Maldives Special Import Form
15–45d medium45dRegulated
Mali MOH Special Import Authorization
Mali Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Mali Special Import Form
15–45d medium45dRegulated
Malta 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 Malta.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
MAPHAR Autorisation Exceptionnelle d'Importation – Morocco
Morocco's Direction du Médicament (MAPHAR) exceptional import authorization for unregistered medicines for patients with serious medical needs.
Form: MAPHAR Exceptional Import Form
15–45d medium30dDahir No. 1-06-151 (Moroccan Drug Law)
Marshall Islands MOH Special Import Authorization
Marshall Islands Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Marshall Islands Special Import Form
>45d slow60dRegulated
Mauritania MOH Special Import Authorization
Mauritania Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Mauritania Special Import Form
15–45d medium45dRegulated
MCAZ Special Authorization – Zimbabwe
Zimbabwe Medicines Control Authority special authorization for import and use of unregistered medicines for patients with serious medical needs.
Form: MCAZ Special Authorization Form
15–45d medium30dMedicines and Allied Substances Control Act
Medsafe Section 29 Special Clinical Circumstances – NZ
New Zealand Medsafe allows prescribers to obtain and use unapproved medicines for specific patients under Section 29 of the Medicines Act 1981 in special clinical circumstances.
Form: Medsafe S29 Notification
<15d fast14dMedicines Act 1981 Section 29
MFDS Expanded Access Program – South Korea
Permits use of an unapproved investigational drug for treatment purposes where a patient has a life-threatening or seriously debilitating condition and no alternative therapy is available. MFDS operates two tracks: approval for an individual patient, and approval covering multiple patients.
Form: Application for Use of Investigational Product for Treatment Purposes
15–45d medium30dPharmaceutical Affairs Act Art. 34(4); Regulation on Safety of Pharmaceutical Drugs Arts. 28-29
MFDS Marketing Authorisation & Orphan Drug Designation – South Korea
Standard route to market. The Ministry of Food and Drug Safety grants marketing authorisation, and separately designates orphan drugs (희귀의약품). Designation requires a domestic patient population of 20,000 or fewer, or an equivalent unmet-need ground, and the Korea Orphan & Essential Drug Center issues the designation recommendation that supports the application.
Form: Orphan Drug Designation Recommendation (희귀의약품 지정 추천서)
Regulation on Designation of Orphan Drugs Arts. 3-4 (MFDS Notice 2026-8); Pharmaceutical Affairs Act Art. 2(18)
Micronesia MOH Special Import Authorization
Micronesia Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Micronesia Special Import Form
>45d slow60dRegulated
MOH Lebanon Special Import Authorization
Lebanon Ministry of Health special import authorization allowing physicians to import unregistered medicines for named patients with serious medical needs.
Form: MOH Lebanon Special Import Form
15–45d medium30dLebanon Drug Regulatory Framework
MOH Qatar Compassionate Use Program
Qatar Ministry of Public Health compassionate use program allowing access to unregistered medicines for patients with serious or life-threatening conditions.
Form: MOPH Qatar CU Form
15–45d medium21dQatar Drug Regulation
MOHAP Named Patient Program – UAE
UAE Ministry of Health and Prevention allows import of unregistered medicines for individual named patients under physician supervision and MOHAP approval.
Form: MOHAP NPP Application Form
<15d fast14dFederal Law No. 4 of 1983
Moldova MOH Special Import Authorization
Moldova Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Moldova Special Import Form
15–45d medium30dRegulated
Monaco Special Import (via EMA framework)
Monaco special import authorization for unregistered medicines using the EMA/EU regulatory framework via neighboring EU country channels.
Form: Monaco Special Import Form
<15d fast14dVia EU/EMA regulatory framework
Mongolia MOH Special Import Authorization
Mongolia Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Mongolia Special Import Form
15–45d medium45dRegulated
Montenegro Compassionate Use Authorization
Montenegro regulatory authority compassionate use authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: Montenegro CU Application Form
15–45d medium30dRegulated
Mozambique MOH Special Import Authorization
Mozambique Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Mozambique Special Import Form
15–45d medium45dRegulated