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Unlicensed medicines

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Guidance for the Purchase and Supply of Unlicensed Medicinal Products Notes for Prescribers and Pharmacists (Yellow Cover)

29 July 2013Recommendations to prescribers and pharmacists involved in the use or procurement of unlicensed medicines and guidance on the assessment of their quality

Quality Assessment of Unlicensed Medicines

16 November 2016The purpose of this document is to provide detailed guidance on the pharmaceutical quality assessment of unlicensed medicines. The principles are applicable both to unlicensed…

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.

Suppliers Audit Database

16 December 2016The supplier audit databases have been set up to make best use of the NHS supplier audits performed across the United Kingdom

Risk Associated with the Outsourcing of the Aseptic Compounding of Parenteral Nutrition (Yellow Cover)

16 December 2016The purpose of this document is to give guidance to those outsourcing PN compounding on the risks in the outsourcing and supply process and to…

Unlicensed Imported Medicines - Guidance for the overlabelling and provision of translated information

21 January 2019This guidance will be of use to anyone purchasing, overlabelling or supplying imported unlicensed medicines, and obtaining or providing translated leaflets.

Using Standardised Strengths of Unlicensed Liquid Medicines in Children

10 October 2019A joint statement from the Neonatal and Paediatric Pharmacy Group (NPPG) and the Royal College of Paediatrics and Child Health (RCPCH)

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
Registration required

Vincristine: Cytotoxic Drug Stability Monograph

15 December 2020Stability information is essential for the safe aseptic preparation of vincristine
Registration required

Cabazitaxel: Cytotoxic Drug Stability Monograph

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