TSE Regulations

We have introduced legislation to apply the European Commission's guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products administered to humans to unlicensed medicines.

The Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003 (SI 2003/1680) came into force on the 30 July 2003. From this date all manufacturers, importers and exporters of unlicensed medicinal products for human use are required to comply with the provisions of the Regulations. To help with this requirement we have produced interim guidance on the TSE Regulations. (188Kb) We have also issued a policy document (80Kb) outlining acceptable practices for importers in assessing compliance of prospective imports of exempt imported products as defined in Statutory Instrument 1999/4, The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1999 (SI 1999/4) with UK TSE Regulations.


Page last modified: 26 February 2008