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European Directorate for the
Quality of Medicines & HealthCare

European Directorate for the <br> Quality of Medicines & HealthCare
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  1. European Directorate for the Quality of Medicines & HealthCare
  2. Medicines
  3. Certification of Suitability (CEP)

Certification of Suitability (CEP)

  • Certification monthly report of activities: End of October 2023
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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...

  • CEP 2.0: new requirements for the content of the chemical purity and herbal drugs/herbal drug preparation dossiers
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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...

  • Certification monthly report of activities: End of September 2023
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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...

  • CEP holders invited to comment on draft monographs published in Pharmeuropa 35.4
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    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...

  • Implementation of the European Pharmacopoeia Supplement 11.4 – Notification for CEP holders
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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...

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Find your way - Topics

About the Procedure

Background & Legal Framework

Mission & Organisation

CEP 2.0

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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