Revised EDQM guideline "Content of the dossier for a substance for TSE risk assessment"

By | Updated: 2018-01-16 08:46:43

Certification of suitability (CEP)Products with risk of TSE          News          10 January 2018          Strasbourg, France

EDQM has revised the guideline "Content of the dossier for a substance for TSE risk assessment". The revision takes into account all recent regulatory changes in the field and a new paragraph has been added with regard to the requirements for raw materials used for medical devices. This document is intended to give applicants instructions of what kind of information is expected in a dossier submitted to get a TSE CEP.

Content of the Dossier for a Substance for TSE Risk Assessment (PA PH CEP (06) 2 1R).pdf