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European Directorate for the
Quality of Medicines & HealthCare

Certification of Suitability (CEP)

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Nov 10, 2023
Certification monthly report of activities: End of October 2023

EDQM Strasbourg, France 10/11/2023

The latest monthly activity report for the Certification of Substances Department (DCEP) is now...
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Nov 9, 2023
CEP 2.0: new requirements for the content of the chemical purity and herbal drugs/herbal drug preparation dossiers

EDQM Strasbourg, France 09/11/2023

The European Directorate for the Quality of Medicines & HealthCare (EDQM) wishes to provide...
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Oct 6, 2023
Certification monthly report of activities: End of September 2023

EDQM Strasbourg, France 06/10/2023

The latest monthly activity report for the Certification of Substances Department (DCEP) is now...
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- Email
Oct 6, 2023
CEP holders invited to comment on draft monographs published in Pharmeuropa 35.4

EDQM Strasbourg, France 06/10/2023

Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are...
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Oct 6, 2023
Implementation of the European Pharmacopoeia Supplement 11.4 – Notification for CEP holders

EDQM Strasbourg, France 06/10/2023

Supplement 11.4 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of...

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

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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