Regulatory Pathways
229 pathwaysNamed 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 Programme – United Kingdom
The UK named patient supply route allows a prescriber to request an unlicensed medicine for an individual patient where a suitable licensed product is not available and the prescriber takes responsibility for the treatment. Supply is typically made under a specific patient prescription rather than general market authorization.
Form: Named patient prescription / import request as applicable
Statutory/Administrative
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
Niger MOH Special Import Authorization
Niger Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Niger Special Import Form
15–45d medium45dRegulated
NMPA Compassionate Use – China
China's NMPA allows conditional approval and compassionate use of drugs under the 2019 Drug Administration Law for patients with serious or life-threatening conditions who have no other options.
Form: NMPA CU Application
>45d slow60dDrug Administration Law 2019 Article 23
NMRA Special Import Authorization – Sri Lanka
Sri Lanka National Medicines Regulatory Authority special import authorization for unregistered medicines for patients with serious medical needs.
Form: NMRA SIA Form
15–45d medium21dNational Medicines Regulatory Authority Act
NMRC Special Import Authorization – Namibia
Namibia Medicines Regulatory Council special import authorization for unregistered medicines for patients with serious medical needs.
Form: NMRC Special Import Form
15–45d medium30dMedicines and Related Substances Control Act
North Korea MOH Special Import Authorization
North Korea Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH North Korea Special Import Form
15–45d medium45dRegulated
North Macedonia Compassionate Use Authorization
North Macedonia regulatory authority compassionate use authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: North Macedonia CU Application Form
15–45d medium30dRegulated
Norway 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 Norway.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
NPRA Special Access Scheme – Malaysia
Malaysia's National Pharmaceutical Regulatory Agency Special Access Scheme allowing access to unregistered medicines for patients with serious or life-threatening conditions.
Form: NPRA SAS Form
<15d fast14dControl of Drugs and Cosmetics Regulations 1984
Oman MOH Special Import Program
Oman Ministry of Health special import permit allowing access to unregistered medicines for patients with serious or life-threatening conditions requiring treatment not available locally.
Form: MOH Oman Import Permit
15–45d medium30dOman Drug Regulation
Palau MOH Special Import Authorization
Palau Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Palau Special Import Form
>45d slow60dRegulated
Panama MOH Named Patient Authorization
Panama Ministry of Health named patient authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Panama Named Patient Form
15–45d medium30dRegulated
Paraguay MOH Special Import Authorization
Paraguay Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.
Form: MOH Paraguay Special Import Form
15–45d medium30dRegulated
Pharmacy Board Special Import Permit – Mauritius
Mauritius Pharmacy Board special import permit for unregistered medicines for patients with serious medical conditions.
Form: Pharmacy Board Mauritius Special Import Form
<15d fast14dPharmacy Act (Mauritius)
Poland 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 Poland.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
Portugal 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 Portugal.
Form: National compassionate use form
15–45d medium30dRegulated under EU Directive 2001/83/EC
PPB Special Import Permit – Kenya
Kenya's Pharmacy and Poisons Board special import permit for unregistered medicines for named patients with serious medical conditions.
Form: PPB SIP Form
15–45d medium21dPharmacy and Poisons Act Cap 244