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.
Unlicensed medicines podcast series
A series of podcasts about unlicensed medicines
Other content on unlicensed medicines
Outsourcing aseptically prepared parenteral nutrition
When outsourcing aseptically prepared parenteral nutrition, consider risks to patient safety.
Outsourcing aseptically prepared chemotherapy medicines
Guidance Aseptically prepared outsourced chemotherapy medicines are unlicensed medicines. The NHS Pharmaceutical QA Committee has published three guidance documents to help pharmacies to address risks…
Outsourcing outpatient parenteral antibiotic therapy
When outsourcing aseptically prepared OPAT, consider risks to patient safety
Using food supplements
Food supplements have a place in therapy. We explain when using a food supplement may be appropriate and how to assess the risks.
Understanding food supplements
Food supplements are manufactured and regulated differently to medicines. Understanding the differences informs safe and appropriate treatment decisions.
Unlicensed medicines and use of PGDs
This page explains why PGDs are not a legal mechanism for the administration or supply of unlicensed medicines.
Unlicensed medicines podcast series
A series of podcasts about 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)
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