Avenue de l'Europe
F-67075 Strasbourg Cedex
Tel. +33 (0)3 88 41 20 00
www.coe.int

European Directorate for the
Quality of Medicines & HealthCare

Certification of Suitability (CEP)

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Apr 8, 2024
How to identify the manufacturing sites linked to CEP application (revised document)?

EDQM Strasbourg, France 08/04/2024

Please consult the revised policy document which has been updated to complete the identification...
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Apr 8, 2024
CEP holders invited to comment on draft monographs published in Pharmeuropa 36.2

EDQM Strasbourg, France 08/04/2024

Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are...
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Apr 8, 2024
Certification monthly report of activities: End of March 2024

EDQM Strasbourg, France 08/04/2024

The latest monthly activity report for the Certification of Substances Department (DCEP) is now...
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Apr 4, 2024
As a CEP applicant, you want to improve the quality of your dossier? The revised EDQM guideline “content of the dossier” and other key documents will be useful tools

EDQM Strasbourg, France 04/04/2024

The revised version of the EDQM guideline “Content of the dossier for chemical purity and...
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Mar 28, 2024
How CEP holders can avoid the rejection of notifications

EDQM Strasbourg, France 28/03/2024

In order to facilitate the acceptance of proposed changes in a timely manner, CEP holders are...

Find your way - Topics

About the Procedure

Background & Legal Framework

Mission & Organisation

The Inspection Programme

More information about fees

Fees for Certificates of Suitability (CEP)

Build your CEP application

New applications

Notifications, Revisions, Renewals and Sister Files

Submission format and electronic submission

Certification policy documents and Guidelines

Technical Advice & One-to-One Meetings

Useful links

Certification database

Certification database

CEP 2.0

CEP 2.0

Actions on Certificates

Actions on Certificates

Nitrosamines contamination

Nitrosamines contamination

Policies & Guidelines

Policies & Guidelines

Consultation space

Consultation space

FAQ & HelpDesk

FAQ & HelpDesk

Fees for CEPs

Fees for CEPs

eLearning

eLearning

Upcoming events

11 & 12 June 2024 Palais de l’Europe, Strasbourg (France)

Save the date “TODAY, TOMORROW, TOGETHER FOR PUBLIC HEALTH”

The CEP at a glance - Infographic

The CEP at a glance - Infographic

11th Edition at a glance

11th Edition at a glance

Overview of pharmacopoeia related products and services

Overview of pharmacopoeia related products and services

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