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Certification of TSE risk products is applied to all material derived from animals which are susceptible to the transmission of TSE agents, as described in general chapter of the PhEur (5.2.8) which is verbatim the EMEA NfG on Minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products. The certification procedure requires the presentation of a dossier as described in Appendix II of Resolution AP-CSP (99) 4. Assessment of certification applications will be based on the criteria of European Pharmacopoeia chapter 5.2.8.

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