Named Patient Unlicensed Medicine – UK
Physician DeclarationLegal under Human Medicines Regulations 2012 Reg 1677 days
Description & Eligibility
UK physicians can prescribe unlicensed medicines for named patients under their personal responsibility. The prescriber takes responsibility for the decision and monitors the patient.
Eligibility Criteria
Serious or life-threatening condition with no locally registered alternative
Legal Reference / Source
MHRA Unlicensed Medicines Guidance
Countries Using This Pathway (1)
Named Patient Unlicensed Medicine – UK
| Approval Form | Physician Declaration |
| Timeline | 7 days |
| Legal Status | Legal under Human Medicines Regulations 2012 Reg 167 |
| Source Ref. | MHRA Unlicensed Medicines Guidance |
| Countries | 1 countries |
Compliance Check
Legal Review3/11/2026
Global ValidityVerified