The supply of unlicensed medicinal products (“specials”) MHRA Guidance Note 14

· Medicines and Healthcare products Regulatory Agency (MHRA)

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines and medical devices work, are safe and of appropriate quality. The MHRA’s primary aim is to safeguard public health through a system of regulation. Pharmaceutical manufacturers and distributors operating in the UK marketplace are subject to a system of licensing and inspection, which ensures that licensed medicinal products conform to internationally-agreed standards, and that those medicines are manufactured, stored and distributed in compliance with the required regulatory standards.
The regulation of medicines on the UK market is undertaken by MHRA in accordance with the Human Medicines Regulations 2012 (SI 2012/1916).
This Guidance Note provides advice on the manufacture, importation, distribution and supply of unlicensed medicinal products for human use (commonly described as “specials”) which have been specially manufactured or imported to the order of a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber for the treatment of individual patients
Patient Group DirectionsRegulatory AdviceSafety in LactationSystem Safety

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