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.

Read More

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...

Read More

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.

Read More

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...

Read More

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.

Read More

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...

Read More

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...

Read More

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.

Read More

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...

Read More

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...

Read More

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...

Read More

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...

Read More

Certification monthly report of activities: End of December 2021

EDQM 10/01/2022 Strasbourg, France

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

Read More

“CEP of the future”: project update

EDQM 06/01/2022 Strasbourg, France

The consultation phase of the project to design the Certificate of suitability to the monographs of the European Pharmacopoeia (CEP) of the future has been completed. The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the survey outcome and a roadmap for...

Read More

Certification monthly report of activities: October & November 2021

EDQM 14/12/2021 Strasbourg, France

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

Read More

Change in EDQM timelines for CEP applications

EDQM 26/11/2021 Strasbourg, France

On 1 October 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) commenced the use of a new IT tool to manage CEP applications. The implementation of this tool requires that timelines for evaluation of all CEP applications and their revisions/renewal be specified in...

Read More

CEP holders invited to comment on draft monographs published in Pharmeuropa 33.4

EDQM 20/10/2021 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 33.4. The table below lists the substances...

Read More

Implementation of the European Pharmacopoeia Supplement 10.7 – Notification for CEP holders

EDQM 19/10/2021 Strasbourg, France

Supplement 10.7 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 April 2022, and to follow the...

Read More

Certification monthly report of activities: September 2021

EDQM 08/10/2021 Strasbourg, France

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

Read More

Risk of the presence of mutagenic azido impurities in losartan active substance

EDQM 29/09/2021 Strasbourg, France

In April 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) reported that it had received information about the possible presence of potentially mutagenic azido impurities in certain sartan active substances. Investigations requested by the EDQM indicated that only a...

Read More