Unlicensed medicines
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Governance principles for unlicensed medicines
17 July 2024Factors to consider when unlicensed medicines are used, ensuring good governance.
Using unlicensed medicines
27 June 2024The decision to use an unlicensed medicine is a shared responsibility and must meet the patient's special clinical need.
Evaluating the quality of imported Specials
24 June 2024Information from suppliers enables purchasers to assess the quality of imported unlicensed medicines
Evaluating the quality of UK Manufactured Specials
24 June 2024Information from suppliers enables purchasers to assess the quality of UK manufactured Specials
Off-label or unlicensed product use under HMR 2012 exemptions
8 April 2024A legal position summary regarding the sale, supply or administration of off-label/unlicensed products under Schedule 17 of the Human Medicines Regulations 2012
Making unlicensed medicines
30 November 2023Medicines may be made without the need for a marketing authorisation in some circumstances
Using Standardised Strengths of Unlicensed Liquid Medicines in Children
10 August 2023A 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
12 April 2022National guidance from NHSE/I to reduce LASA errors and improve patient safety when considering requirements for unlicensed specials medicines
Unlicensed medicines
All our advice relating to making, purchasing and using unlicensed medicines.