2021 Highlights – EDQM annual report now available

EDQM 14/06/2022 Strasbourg, France

Download: 2021 Highlights – EDQM annual report The 2021 annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM) is now available, providing a comprehensive overview of its activities and achievements. New to this edition is a four-page summary of key facts and...

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16 replacement batches released in May 2022

EDQM 07/06/2022 Strasbourg, France

Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Information on change of price Change of EDQM storage/shipping conditions See also: Content of the Ph. Eur. RS catalogue How to place an RS order The European Directorate for the Quality of Medicines...

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European Pharmacopoeia 11th Edition (11.0-11.2) – Subscriptions now open!

EDQM 26/04/2022 Strasbourg, France

The 2023 subscriptions to the European Pharmacopoeia (Ph. Eur.), including the initial release (11.0) and the first two supplements (11.1-11.2), are now available for sale in the WebStore of the European Directorate for the Quality of Medicines & HealthCare (EDQM). Subscribers may choose either...

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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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24 replacement batches released in April 2022

EDQM 06/05/2022 Strasbourg, France

Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Information on change of price Change of EDQM storage/shipping conditions See also: Content of the Ph. Eur. RS catalogue How to place an RS order   The EDQM announces the release of: 24 replacement...

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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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13 replacement batches released in March 2022

EDQM 06/04/2022 STRASBOURG, FRANCE

Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Information on change of price Change of EDQM storage/shipping conditions See also: Content of the Ph. Eur. RS catalogue How to place an RS order   The European Directorate for the Quality of...

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New EDQM website, redesigned to better serve your needs – Now online!

EDQM 01/04/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just launched its redesigned website. Discover the following new features. Improved, user-friendly navigation by main topics. This means faster access – in fewer clicks – to the information you need using the top menu...

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Pharmeuropa 34.2 just released

EDQM 04/04/22 Strasbourg, France

All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 34.2 is 30 June 2022. Users and interested parties are welcome to comment on these drafts. It should be...

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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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20 replacement batches released in February 2022

EDQM 03/03/2022 STRASBOURG, FRANCE

Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Information on change of price Change of EDQM storage/shipping conditions See also: Content of the Ph. Eur. RS catalogue How to place an RS order   The European Directorate for the Quality of...

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Suspension of shipments

EDQM 02/03/2022 STRASBOURG, FRANCE

Due to the recent events in Ukraine, all carriers have suspended their activities in Belarus, Moldova, Russia and Ukraine until further notice. Therefore, the EDQM can no longer proceed with any shipments for Reference Standards, Publications or PTS to these countries.

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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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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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2 new reference standard and 19 replacement batches released in January 2022

EDQM 02/02/2022 Strasbourg, France

New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Information on change of price Change of EDQM storage/shipping conditions See also: Content of the Ph. Eur. RS catalogue How to place an RS order   The European...

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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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New-format order confirmation for reference standards and publications

EDQM 10/12/2021 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has updated its order confirmations to make them easier to read, including clearly identifying: the estimated shipping date for each product; any information the EDQM needs from you in order to ship your order; if your...

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