The Medicines and Healthcare products Regulatory Agency (MHRA), has introduced legislation designed to minimise the risk of transmissable spongiform encephalopathies (TSE). The legislation works by prohibiting the supply of certain unlicensed medicines unless they have been manufactured in accordance with the 'Notes for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products' as published and updated by the European Commission.

The regulation of certain unlicensed medicines for human use is needed in order to minimise the risk of the transmission of transmissible spongiform encephalopathies (TSE) via those products.

The legislation, 'The Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations (S.I. 2003/1680)', came into force on 30 July 2003. Dentists who specially prepare medicines in the course of their business are not exempt and are required to comply with the Regulations. The Regulations, which also contain a procedure to determine compliance and a requirement for a designated record-keeper to keep evidence of compliance, affect all manufacturers and importers/exporters of certain unlicensed medicinal products.

To help with this requirement the MHRA has produced interim guidance on the Regulations which is available from the MHRA website: http://medicines.mhra.gov.uk/ourwork/licensingmeds/exemptions/tseinterimguide.pdf.

Dentists, particularly those who prepare medicines, that have a query relating to this matter should contact the Inspection and Enforcement Policy Unit at MHRA, which is responsible for the Regulations on 020 7084 2131 or 020 7084 2573 for further advice. A copy of S.I. 2003/1680 can be obtained free of charge from www.hmso.gov.uk/stat.htm or from The Stationery Office (ISBN 0-11-046735-3) price £2.00.