Unlicensed medicines

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Unlicensed medicines and use of PGDs

15 December 2020This page clarifies why a PGD is illegal for unlicensed medicines - note exceptions under Regulation 174 below

The supply of unlicensed medicinal products (“specials”) MHRA Guidance Note 14

9 September 2020The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines and medical devices work, are safe and of appropriate quality. The…

Can patients receive unlicensed medicines under a PGD?

8 September 2020No, the PGD framework does not allow for unlicensed medicines to be supplied and /or administered. For example, imported medicines (e.g. licensed in another country but not…

MUS Webinar – Unlicensed medicines: Stories from COVID and tips for the future

22 September 202022 September 2020  13.00 – 14.00 During the Covid emergency, unlicensed and other imported medicines were used as substitutes for critical care licensed medicines to…

Can off label or unlicensed products be sold, supplied or administered under Schedule 17 of the Human Medicines Regulations 2012 exemptions?

8 January 2020Exceptions to the general rule for which certain healthcare professionals can sell, supply, and/or administer medicines to patients under Schedule 17 of the Human Medicines…

Using Standardised Strengths of Unlicensed Liquid Medicines in Children: joint statement from the Neonatal and Paediatric Pharmacists’ Group (NPPG) and the Royal College of Paediatrics and Child Health (RCPCH)

10 October 2019NPPG and RCPCH strongly recommend that when children require unlicensed liquid medications, they should receive the RCPCH- and NPPG- recommended strength, where one exists. There…

Guidance to the NHS on the licensing provisions of the Medicines Act 1968. (Medicines Control Agency, 1992)

2 April 2019This document provides guidance and advice which is still relevant to the NHS today, on the application of the licensing provisions of the Medicines Act…

Drug-induced hypersalivation – what treatment options are available?

1 August 2018This Medicines Q&A summarises published studies or case reports concerning the pharmacological treatment of drug-induced hypersalivation (drooling or sialorrhoea), particularly hypersalivation caused by clozapine. Update…

RMOC Recommendation: Standardising strengths of high risk, unlicensed oral liquids formulations for anti-TB medicines

9 April 2018At the meeting on 26th October 2017 the Regional Medicines Optimisation Committee (North) endorsed the approach put forward by the NHS Pharmaceutical Quality Assurance Committee…

Unlicensed Medicines Procurement Procedure Training on How to Develop.

30 August 2016For a number of years Rob Lowe and Kevan Wind have run a course on how to develop a procedure for the procurement of unlicensed…