Tuesday, 18 September 2018

Certification of suitability to the Monographs of the European Pharmacopoeia

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.

See EDQM: https://www.edqm.eu/sites/default/files/guideline-cep-how-to-read-a-cep-may2018.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

No comments:

Post a Comment

Pharmaceutical Microbiology Resources

Special offers