Accessing non-formulary and unlicensed medicines

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The following medicines are currently non-formulary within NHS GGC Mental Health Services (MHS) and are subject to mental health non-formulary (MHS-NF) requests:

  • agomelatine
  • paliperidone (oral)
  • quetiapine MR
  • vortioxetine

Peer Approved Clinical System tier 2 (PACS2) is the process that has replaced Individualised Patient Treatment Requests (IPTRs) in most situations.

Within MHS, the only medicine that is currently subject to the PACS2 process (on cost grounds and non-SMC status) is:

  • olanzapine long-acting injection (Zypadera)
Unlicensed medicines

Medicines that do not have a marketing authorisation (or product licence) in the UK are subject to unlicensed medicine (ULM) requests and require completion of a ULM form. These are (not exhaustive):

  • Sertindole
  • Ziprasidone
  • Clozapine IM

A number of blanket unlicensed protocols exist within MHS to allow use of some ULMs in certain clinical situations without submitting a full ULM form. These are:

Off-label use of medicines occurs when medication is used outside the terms of its marketing authorisation. Where the off-label use is supported by evidence-based texts, the use is generally considered low risk and a ULM form will not be required. Where the off-label use is higher risk, a ULM form may be required.

Please contact the Mental Health Prescribing Management Group for further advice.(


Following approval of medicines subject to NF, PACS2 or ULM processes, PMG-MH will retain a copy of the form for audit purposes and may request feedback after a period of time in order to evaluate local clinical experience.

Editorial Information

Last reviewed: 09 July 2020

Next review: 01 June 2022

Author(s): PMG-MH

Version: 1

Approved By: PMG-MH

Reviewer Name(s): Andrew Walker, Suzanne Burke