EDQM’s ISO 9001:2015 certification maintained

EDQM 08/02/2024 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare’s (EDQM) ISO 9001:2015 certificate has been maintained following the second surveillance audit of its quality management system on 28 and 29 November 2023 by the official French standardisation body Association française de...

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Save the date: EDQM conference celebrating 60 years of excellence in public health protection

EDQM 18/01/2024 Strasbourg, France

In 2024, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is celebrating 60 years of excellence in the protection and promotion of public health. We are delighted to announce the organisation of a conference to mark this occasion, on 11 and 12 June 2024, in Strasbourg...

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1 new Ph. Eur. reference standard and 29 replacement batches released in January 2024

EDQM 01/02/2024 Strasbourg, France

New Ph. Eur. reference standards and Replacement batches for Ph. Eur. reference standards Distribution quota Removal Future removal Change of sales units Information on change of amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International...

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BSP study outcome published in Pharmeuropa Bio & Scientific Notes – Human tetanus immunoglobulin BRP batch 2

EDQM 29/01/2024 Strasbourg, France

The outcome of the Biological Standardisation Programme study BSP140 to establish the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Human tetanus immunoglobulin batch 2 has been published in the online journal Pharmeuropa Bio & Scientific Notes of the European...

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8 replacement batches released in December 2023

EDQM 08/01/2024 Strasbourg, France

Replacement batches for Ph. Eur. reference standards Distribution quota Removal Future removal Change of sales units Information on change of amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International Chemical Reference Substances (ICRS)...

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Cannabis flower for system suitability HRS and cannabidiol for cannabis CRS now available

EDQM 03/01/2024 Strasbourg, France

The standards cannabis flower for system suitability HRS and cannabidiol for cannabis CRS that are described in the newly adopted monograph on Cannabis flower (3028) are now available for users under catalogue code Y0002440 and Y0002422 respectively. More information on how to order is available...

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BSP study outcome published online – Heparin Low-Molecular-Mass CRS batches 4 & 5

EDQM 18/12/2023 Strasbourg, France

The outcome of the BSP121 study to establish batches 4 and 5 of the European Pharmacopoeia Heparin Low-Molecular-Mass for Calibration Chemical Reference Substance (CRS) has been published in the online journal Pharmeuropa Bio & Scientific Notes and is referenced in Medline/PubMed® (Pharmeur Bio...

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1 new Ph. Eur. reference standard and 14 replacement batches released in November 2023

EDQM 04/12/2023 Strasbourg, France

New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Distribution quota Removal Future removal Change of sales units Information on change of amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International...

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Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (cat. # Y0001689)

EDQM 17/11/2023 Strasbourg, France

Due to premature depletion of stocks of the Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (cat. # Y0001689), we wish to inform users that a tight distribution quota has been established. This BRP will be distributed to plasma-derived therapeutic product manufacturers and...

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3 new Ph. Eur. reference standards and 21 replacement batches released in October 2023

EDQM 02/11/2023 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 amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International Chemical Reference...

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17 replacement batches released in September 2023

EDQM 02/10/2023 Strasbourg, France

Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Information on change of amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International Chemical Reference Substances (ICRS) and International...

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2 new Ph. Eur. reference standards and 16 replacement batches released in August 2023

EDQM 08/09/2023 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 amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International Chemical Reference...

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Elemental impurity chemical reference standards (CRS) available in the EDQM reference standards catalogue

EDQM 08/08/2023 Strasbourg, France

Lead solution CRS, Cadmium solution CRS, Mercury solution CRS, Arsenic solution CRS, Nickel solution CRS, Palladium solution CRS and, most recently, Platinum solution CRS are now available in the EDQM RS portfolio. For medicinal products, elemental impurities must be evaluated during risk...

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2 new Ph. Eur. reference standards and 18 replacement batches released in July 2023

EDQM 01/08/2023 Strasbourg, France

New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Information on reference standards removed from catalogue Information on reference standards with a future removal from catalogue Information on change of sales units Information on change of amount per unit...

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4 new Ph. Eur. reference standards and 10 replacement batches released in June 2023

EDQM 03/07/2023 Strasbourg, France

New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Information on reference standards removed from catalogue Information on reference standards with a future removal from catalogue Information on change of sales units Information on change of amount per unit...

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16 replacement batches released in May 2023

EDQM 01/06/2023 Strasbourg, France

Replacement batches for Ph. Eur. reference standards Information on reference standards removed from catalogue Information on reference standards with a future removal from catalogue Change of sales units / price Information on change of amount per unit Change of EDQM storage/shipping conditions...

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Current options for shipping to Ukraine

EDQM 22/05/2023 Strasbourg, France

The EDQM is able to offer several options for shipments to Ukraine. Please consult the linked table: “EDQM shipping options for Ukraine”.

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1 new Ph. Eur. reference standard and 18 replacement batches released in April 2023

EDQM 02/05/2023 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 amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International Chemical Reference...

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20 replacement batches released in March 2023

EDQM 04/04/2023 STRASBOURG, FRANCE

Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Information on change of amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International Chemical Reference Substances (ICRS) and International...

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1 new Ph. Eur. reference standards and 15 replacement batches released in February 2023

EDQM 03/03/2023 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 amount per unit Information on change of price Change of EDQM storage/shipping conditions See also: Content of the Ph. Eur. RS catalogue How...

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