A
new document from the EDQM – ‘how to read a CEP’. This document has been
created with the intention of clarifying the information to be concluded from a
Certificate of suitability to the Monographs of the European Pharmacopoeia
(CEP) for Industry and the Competent Authorities.
Specifically,
this document describes in detail the information conveyed on a CEP. Marketing
Authorisation (MA) applicants are advised to read existing guidance published by
the Competent Authorities in their countries, or to contact them directly for
advice, when using a CEP to replace the respective quality part of the CTD
dossier related to that given source, or in any variation.
Competent
authorities may contact the EDQM if they have questions concerning the content
of the CEP which prevent them performing the evaluation of the MA application (MAA).
If necessary, they may ask for the CEP assessment report. CEPs are normally
accepted in all countries which are members of the Ph. Eur. Convention. CEPs
may be accepted in countries which are not members of the Ph. Eur. Convention
at the discretion of the authorities in those countries.
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology
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Pharmaceutical Microbiology