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Unlicensed medicines

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Cabazitaxel: Cytotoxic Drug Stability Monograph

12 March 2021Stability information is essential for the safe aseptic preparation of cabazitaxel

Evaluating the quality of UK Manufactured Specials

24 June 2024Information from suppliers enables purchasers to assess the quality of UK manufactured Specials

Evaluating the quality of imported Specials

24 June 2024Information from suppliers enables purchasers to assess the quality of imported unlicensed medicines

Explaining the licensed status of medicines

28 July 2023Medicines may be licensed or unlicensed. Some substances that look like medicines may not be legally classed as medicines

Governance principles for unlicensed medicines

30 November 2023Factors to consider when unlicensed medicines are used, ensuring good governance.

Guidance on Managing The Sourcing and Supply of Ready-to-Administer Chemotheraphy Doses for the NHS (Yellow Cover)

5 December 2016This document is aimed at staff in UK NHS hospitals considering or already sourcing their supply of chemotherapy as ready-to-administer doses.

Labelling and packaging of unlicensed medicines (Specials): best practice guidance for the NHS

1 March 2022National guidance from NHSE/I to reduce LASA errors and improve patient safety when considering requirements for unlicensed specials medicines

Making unlicensed medicines

30 November 2023Medicines may be made without the need for a marketing authorisation in some circumstances

Off-label or unlicensed product use under HMR 2012 exemptions

8 January 2020A legal position summary regarding the sale, supply or administration of off-label/unlicensed products under Schedule 17 of the Human Medicines Regulations 2012

Purchasing Specials

30 November 2023Factors to consider when purchasing Specials and imported unlicensed medicines from commercial manufacturers