Module 9 2021

19/03/2021

Transmissible SpongiformEncephalopathy

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Risk Assessment

• Chronic degenerative nervous system disease due to the abnormal isoform of a cellular glycoprotein known as PrP or prion protein (PrPSc) that is infectious in the absence of nucleic acid. • Poses a risk to the Pharmaceutical Industry through the use of a contaminated raw material from ruminant material.

TSE Agent

Low risk country and tissue

Removal of ADRM Safe Product for humans

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The Regulatory Framework for TSE in Europe

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• Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev.3) (Applicable from 1 July 2011) – Since 2000  A guidance document with the force of law [EU] directives require that applicants for Marketing Authorisation for human and veterinary medicinal products must demonstrate that medicinal products are manufactured in accordance with the latest version of this Note for Guidance published in the Official Journal of the European Union. This is a continuing obligation after the Marketing Authorisation has been granted”. – Cornerstones:  SOURCE of animals - country  NATURE of tissue  Production PROCESS  Certificates of Suitability – Assessment based on the above principles

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