Avoiding Transmissible Spongiform Encephalopathies
All applications for marketing authorisation for medicinal products for human use submitted after 1 July 2000 must demonstrate that specific measures were taken to minimize the risk or prevent the transmission of transmissible spongiform encephalopathies (TSEs) of animal origin, and that they comply with the legal provisions. Since 1 March 2001, the marketing authorisation documents for all medicines in the authorisation procedure and for all medicines already on the market must meet these criteria.
In doing so, the applicant must demonstrate at each stage of the manufacturing process that the materials used (in particular the raw materials used in production) comply with the TSE Guidelines.
The TSE Guidelines are also part of the European Pharmacopoeia (see Chapter 5.2.8: Minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products). Evidence of compliance based on the TSE Guidelines or the corresponding pharmacopoeia monograph is also expected in applications for authorisations of clinical trials.