Regulatory Pathways

218 pathways

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

Korea's Ministry of Food and Drug Safety allows use of unapproved drugs through expanded access for patients with life-threatening diseases who have no other treatment options.

Form: MFDS EAP Application

15–45d medium30dPharmaceutical Affairs Act Article 34-2

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

Myanmar MOH Special Import Authorization

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

Form: MOH Myanmar Special Import Form

15–45d medium45dRegulated

NAFDAC Compassionate Use / Expanded Access – Nigeria

Nigeria NAFDAC compassionate use and expanded access program for unregistered medicines needed by patients with serious or life-threatening diseases.

Form: NAFDAC EAP Form

15–45d medium30dNAFDAC Act Cap N1 LFN 2004

Named Patient Import – Form 12B (CDSCO) – India

Under India's New Drugs and Clinical Trials Rules 2019, a named patient can import unapproved drugs on Form 12B with CDSCO approval for personal use to treat a specific disease.

Form: Form 12B

15–45d medium30dNDCT Rules 2019, Rule 101

Named Patient Programme – UK

The UK's Specials licensing route allows unlicensed medicines to be supplied for individual patients under the responsibility of a registered medical practitioner. This pathway is governed by the Human Medicines Regulations 2012 and requires a clear medical need where no licensed alternative exists.

Form: NHS Form FP10 or hospital prescription with clinical justification

<15d fast5dStatutory

Named Patient Supply (Magistrale bereiding) – Netherlands

Dutch named patient supply allowing pharmacists to prepare or import unlicensed medicines for individual named patients under physician prescription.

Form: CBG-MEB Named Patient Form

<15d fast7dGeneesmiddelenwet (Netherlands Medicines Act)

Named Patient Unlicensed Medicine – UK

UK physicians can prescribe unlicensed medicines for named patients under their personal responsibility. The prescriber takes responsibility for the decision and monitors the patient.

Form: Physician Declaration

<15d fast7dLegal under Human Medicines Regulations 2012 Reg 167

Nauru MOH Special Import Authorization

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

Form: MOH Nauru Special Import Form

>45d slow60dRegulated

NDA Uganda Special Import Authorization

Uganda National Drug Authority special import authorization for unregistered medicines for patients with serious medical needs.

Form: NDA Uganda Special Import Form

15–45d medium21dNational Drug Policy and Authority Act (Uganda)

Netherlands 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 Netherlands.

Form: National compassionate use form

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

NHRA Compassionate Use Authorization – Bahrain

Bahrain's National Health Regulatory Authority compassionate use authorization for access to unregistered medicines for patients with serious conditions.

Form: NHRA CU Application

<15d fast14dNHRA Regulatory Framework

Nicaragua MOH Named Patient Authorization

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

Form: MOH Nicaragua Named Patient Form

15–45d medium45dRegulated

Page 6 of 9 (218 total)

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