2004/C 24/06 Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev.3)

2004/C 24/06 Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev.3)

2004/C 24/06

Note for guidance

This revision of the TSE (Transmissible Spongiform Encephalopathy) note for guidance has been undertaken to introduce, inter alia, risk assessment into the regulatory compliance process, to provide clarification on a variety of terms and classifications, and to take into account advances in scientific knowledge, Community legislation and rules affecting the authorisation of medicinal products for human or veterinary use.