Certification monthly report of activities: End of July 2022

EDQM 08/08/2022 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of July Certification Monthly Report For more information, access the Certification Database.

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Nitrosamines – Deadline extension for all CEP holders to complete step 3 Revision to the CEP (now 1 October 2023)

EDQM 04/08/2022 Strasbourg, France

The European medicines regulatory network has agreed to extend the deadline for submissions related to Step 3: variation to the marketing authorisation until 1 October 2023. This extension is intended to allow companies time to perform a thorough investigation and establish any required...

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Certification monthly report of activities: End of June 2022

EDQM 13/07/2022 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of June Certification Monthly Report For more information, access the Certification Database.

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Implementation of the 11th Edition of European Pharmacopoeia – Notification for CEP holders

EDQM 07/07/2022 Strasbourg, France

The 11th Edition of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 January 2023, and to follow the...

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CEP holders invited to comment on draft monographs published in Pharmeuropa 34.3

EDQM 05/07/2022 Strasbourg, France

Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 34.3. The table below lists the substances...

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EDQM ISO 9001:2015 certification renewed

EDQM 24/06/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) successfully obtained the renewal of its certification according to the ISO 9001:2015 standard from the AFNOR certification body, confirming the compliance of the Quality Management System of the EDQM with this standard....

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Certification monthly report of activities: End of May 2022

EDQM 08/06/2022 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of May Certification Monthly Report For more information, access the Certification Database.

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Register now for our upcoming training programme on the Ph. Eur., reference standards and CEPs

EDQM 31/05/2022 Strasbourg, France

8 independent modules – 8 topics – 8 Q&A sessions – All LIVE! This 100% virtual training will focus on chemically defined active substances and cover all the fundamentals related to the use of the European Pharmacopoeia and its reference standards, as well as the procedure for Certification of...

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Certification monthly report of activities: End of April 2022

EDQM 09/05/2022 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of April 2022 Certification Monthly Report For more information, access the Certification Database.

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EDQM sticker no longer to appear on Certificates of suitability

EDQM 12/04/2022 Strasbourg, France

As of the 1 May 2022, the European Directorate for the Quality of Medicines & HealthCare (EDQM) sticker will no longer appear on Certificates of suitability to the European Pharmacopoeia monographs (CEPs). This adhesive sticker (see picture) will no longer be pasted on CEPs next to the wet...

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Certification monthly report of activities: End of March 2022

EDQM 08/04/2022 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of March 2022 Certification Monthly Report For more information, access the Certification Database.

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CEP holders invited to comment on draft monographs published in Pharmeuropa 34.2

EDQM 07/04/2022 Strasbourg, France

Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 34.2. The table below lists the substances...

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Certification monthly report of activities: End of February 2022

EDQM 11/03/22 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of February 2021 Certification Monthly Report For more information, access the Certification Database.

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Update of application forms for Certificate of Suitability applications

02/03/2022 STRASBOURG, FRANCE

The forms for the submission of Certificate of Suitability to the European Pharmacopoeia monographs (CEP) applications (new applications, revisions and sister files) have been updated in order to facilitate their handling and the transfer of the collected data in the new IT tools implemented at...

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EDQM remote inspections: from pilot phase to a permanent element of EDQM’s inspection scheme!

EDQM 23/02/2022 STRASBOURG, FRANCE

In March 2020 travel restrictions, designed to minimise the spread of SARS-CoV-2, interrupted the inspection programme of the European Directorate for the Quality of Medicines & HealthCare (EDQM), which monitors compliance with both Good Manufacturing Practice (GMP) and applications for...

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Certification monthly report of activities: End of January 2022

EDQM 11/02/2022 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. January 2022 Certification Monthly Report For more information, access the Certification Database.

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EDQM reminds CEP holders of their responsibilities towards their customers

EDQM 03/02/2022 Strasbourg, France

CEP holders have obligations towards the marketing authorisation holders in order to enable them to fulfil their respective legal responsibilities. Recent issues have demonstrated the lack of knowledge of some CEP holders regarding those obligations. In order to clarify the issue, EDQM has...

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How to use the EDQM DCEP sharing tool

EDQM 31/01/2022 Strasbourg, France

The EDQM DCEP sharing tool is a new IT tool used to ensure the secure sharing of EDQM documents between the EDQM Certification of Substances Department (DCEP) and CEP holders or applicants during the CEP lifecycle. Specific instructions are given to the intended users for the creation and the...

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Implementation of the European Pharmacopoeia Supplement 10.8 – Notification for CEP holders

EDQM 21/01/2022 Strasbourg, France

Supplement 10.8 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 July 2022, and to follow the...

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CEP holders invited to comment on draft monographs published in Pharmeuropa 34.1

EDQM 20/01/2022 Strasbourg, France

Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 34.1. The table below lists the substances...

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