Named Patient Programme – UK

NHS Form FP10 or hospital prescription with clinical justificationStatutory5 days

Description & Eligibility

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.

Eligibility Criteria

Patients with unmet medical needs where no licensed alternative is available, prescribed by a UK-registered doctor

Legal Reference / Source

Human Medicines Regulations 2012, Regulation 167

Named Patient Programme – UK
Approval FormNHS Form FP10 or hospital prescription with clinical justification
Timeline5 days
Legal StatusStatutory
Source Ref.Human Medicines Regulations 2012, Regulation 167
Countries0 countries
Compliance Check
Legal Review3/21/2026
Global ValidityVerified
Named Patient Programme – UK — Regulatory Pathway | OrphanDrug