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European Directorate for the
Quality of Medicines & HealthCare

Certification of Suitability

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Feb 3, 2023
Certification monthly report of activities: End of January 2023

EDQM strasbourg, france 03/02/2023

The latest monthly activity report for the Certification of Substances Department (DCEP) is now...
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Jan 30, 2023
CEP holders – How to submit a nitrosamine risk assessment

EDQM Strasbourg, France 30/01/2023

To facilitate the acceptance of proposed changes in a timely manner, the European Directorate for...
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Jan 20, 2023
Implementation of the European Pharmacopoeia Supplement 11.2 – Notification for CEP holders

EDQM Strasbourg, France 20/01/2023

Supplement 11.2 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of...
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Jan 18, 2023
User satisfaction survey: revamped EDQM website

EDQM Strasbourg, France 18/01/2023

The European Directorate for the Quality of Medicines & HealthCare (EDQM) launched its new...
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Jan 10, 2023
CEP holders invited to comment on draft monographs published in Pharmeuropa 35.1

EDQM Strasbourg, France 10/01/2023

Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are...

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About the Procedure

Background & Legal Framework

Mission & Organisation

The CEP of the future

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

The CEP of the future

The CEP of the future

Actions on Certificates

Actions on Certificates

Nitrosamines contamination

Nitrosamines contamination

Policies & Guidelines

Policies & Guidelines

Consultation space (coming soon)

Consultation space (coming soon)

FAQ & HelpDesk

FAQ & HelpDesk

Fees for CEPs

Fees for CEPs

eLearning

eLearning

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EDQM 02/01/2023 Strasbourg, France

Information for CEP applicants - EDQM-DCEP non-working days in 2023

11th Edition at a glance

11th Edition at a glance

Upcoming events

Overview of pharmacopoeia related products and services

Overview of pharmacopoeia related products and services

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