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These guidelines provide evidence-based information to national regulatory authorities, especially to those where Bovine Spongiform Encephalopathy (BSE) has not yet been reported and where surveillance systems for BSE and variant Creutzfeldt-Jakob disease (vCJD), the human disease caused by infection with the BSE agent, may not be in place. Preventive measures to minimise the risk of transmitting TSEs to humans from pharmaceutical and biological products in which ruminant animal-derived materials are used and from humans to humans by blood and blood products and by human cells, tissues and organs are discussed.