Understanding unlicensed medicines
Unlicensed medicines can help where patients have special clinical needs.
Understanding unlicensed medicines
An understanding of the different types of unlicensed medicine will help in meeting patients' special clinical needs
Explaining the licensed status of medicines
Medicines may be licensed or unlicensed. Some substances that look like medicines may not be legally classed as medicines
Using unlicensed medicines
The decision to use an unlicensed medicine is a shared responsibility and must meet the patient's special clinical need.
Purchasing Specials
Factors to consider when purchasing Specials and imported unlicensed medicines from commercial manufacturers
Evaluating the quality of UK Manufactured Specials
Information from suppliers enables purchasers to assess the quality of UK manufactured Specials
Evaluating the quality of imported Specials
Information from suppliers enables purchasers to assess the quality of imported unlicensed medicines
Making unlicensed medicines
Medicines may be made without the need for a marketing authorisation in some circumstances
Governance principles for unlicensed medicines
Factors to consider when unlicensed medicines are used, ensuring good governance.
Other content on unlicensed medicines
Labelling and packaging of unlicensed medicines (Specials): best practice guidance for the NHS
National guidance from NHSE/I to reduce LASA errors and improve patient safety when considering requirements for unlicensed specials medicines
Unlicensed medicines and use of PGDs
This page explains why PGDs are not a legal mechanism for the administration or supply of unlicensed medicines.
Summary of biopharmaceutical stability data reviewed and available extended shelf-life data
The stability of several aseptically compounded ready to administer presentations of monoclonal antibody products and other biopharmaceuticals is presented.
Cabazitaxel: Cytotoxic Drug Stability Monograph
Stability information is essential for the safe aseptic preparation of cabazitaxel
Vincristine: Cytotoxic Drug Stability Monograph
Stability information is essential for the safe aseptic preparation of vincristine
Unlicensed medicines
All our advice relating to making, purchasing and using unlicensed medicines.
Off-label or unlicensed product use under HMR 2012 exemptions
A legal position summary regarding the sale, supply or administration of off-label/unlicensed products under Schedule 17 of the Human Medicines Regulations 2012
Using Standardised Strengths of Unlicensed Liquid Medicines in Children
A joint statement from the Neonatal and Paediatric Pharmacy Group (NPPG) and the Royal College of Paediatrics and Child Health (RCPCH)
Risk Associated with the Outsourcing of the Aseptic Compounding of Parenteral Nutrition (Yellow Cover)
The purpose of this document is to give guidance to those outsourcing PN compounding on the risks in the outsourcing and supply process and to…
Guidance on Managing The Sourcing and Supply of Ready-to-Administer Chemotheraphy Doses for the NHS (Yellow Cover)
This document is aimed at staff in UK NHS hospitals considering or already sourcing their supply of chemotherapy as ready-to-administer doses.