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Certification of TSE risk products is applied to all material All materials submitted for certification that are derived from animals which are susceptible to the transmission of TSE agentsthat carry the risk of transmitting agents of animal spongiform encephalopathies (TSE) require a TSE risk assessment, as described in general chapter of the PhEur (the general monograph Products with risk of transmitting agents of animal spongiform encephalopathies (1483) and general chapter 5.2.8) of the Ph. Eur., which is verbatim the EMEA NfG on Minimising identical to the EMA Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products. The certification Certification procedure requires the presentation of a dossier as described in the EDQM guideline Content of the dossier for a substance for TSE risk assessment (PA/PH/CEP (06)2, 1R).

Appendix II of Resolution AP-CSP (99) 4. Assessment of certification applications will be is based on the criteria of European Pharmacopoeia general chapter 5.2.8 of the Ph. Eur.