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All materials submitted for certification that are derived from animals that carry the risk of transmitting agents of animal spongiform encephalopathies (TSE) require a TSE risk assessment, as described in 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 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 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).

Assessment of certification applications is based on the criteria of general chapter 5.2.8 of the Ph. Eur.



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