Named Patient Programme – UK

MHRA Unlicensed Medicinal Products Notification FormStatutory28 days

Description & Eligibility

Allows UK physicians to prescribe unauthorized medicines to meet special patient needs. Request must be initiated by physician and approved by MHRA on case-by-case basis.

Eligibility Criteria

Patients with unmet medical needs where licensed alternatives are unsuitable

Legal Reference / Source

UK Human Medicines Regulations 2012, Regulation 167

Named Patient Programme – UK
Approval FormMHRA Unlicensed Medicinal Products Notification Form
Timeline28 days
Legal StatusStatutory
Source Ref.UK Human Medicines Regulations 2012, Regulation 167
Countries0 countries
Compliance Check
Legal Review3/21/2026
Global ValidityVerified