Unlicensed medicines

Purchasing Specials

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

Making unlicensed medicines

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

Governance principles for unlicensed medicines

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

Registration required

Purchasing imported unlicensed cisplatin

2 August 2023Trusts may need to purchase imported unlicensed cisplatin for aseptic services. We've collated information about the available products to support local use.

Using unlicensed medicines

28 July 2023The decision to use an unlicensed medicine is a shared responsibility and must meet the patient's special clinical need.

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

Understanding unlicensed medicines

28 July 2023An understanding of the different types of unlicensed medicine will help in meeting patients' special clinical needs

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

Unlicensed medicines and use of PGDs

16 November 2021This page explains why PGD are not legal mechanism for the administration or supply of unlicensed medicines.