Publication on the establishment study for PKA in Albumin BRP replacement batches now online

EDQM 07/10/2024 Strasbourg, France

The outcome of the successful study for the establishment of the European Pharmacopoeia (Ph. Eur.) Prekallikrein Activator (PKA) in Albumin Biological Reference Preparation (BRP) batches 8, 9 and 10 has been published in Pharmeuropa Bio & Scientific Notes, the online scientific journal of the...

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7 new Ph. Eur. reference standard and 19 replacement batches released in September 2024

EDQM 01/10/2024 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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4 new Ph. Eur. reference standard and 15 replacement batches released in August 2024

EDQM 03/09/2024 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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Article on joint WHO/EDQM establishment study for Prekallikrein activator in albumin reference standards now online

EDQM 05/08/2024 Strasbourg, France

The outcome of the successful study to establish the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Prekallikrein activator in albumin batch 7 has been published in the scientific journal Pharmeuropa Bio & Scientific Notes. The study (BSP153) was organised jointly by...

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4 new Ph. Eur. reference standard and 19 replacement batches released in July 2024

EDQM 01/08/2024 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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Publication of BSP study outcome on anti-D antibodies in IVIG reference standards available online

EDQM 29/07/2024 Strasbourg, France

A new article on the outcome of the study for the establishment of replacement batches of reference standards to control the level of anti-D antibodies in human immunoglobulin products for intravenous administration has been published in the online journal Pharmeuropa Bio & Scientific Notes. The...

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Making a significant difference – 2023 EDQM annual report published in new engaging digital format

EDQM 27/06/2024 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has published its 2023 annual report. For the first time, the report is completely digital, with a new, intuitive design and interactive features, facilitating your discovery journey and making it...

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8 new Ph. Eur. reference standard and 18 replacement batches released in June 2024

EDQM 02/07/2024 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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5 new Ph. Eur. reference standard and 13 replacement batches released in May 2024

EDQM 04/06/2024 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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5 new Ph. Eur. reference standard and 20 replacement batches released in April 2024

EDQM 02/05/2024 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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7 new Ph. Eur. reference standard and 17 replacement batches released in March 2024

EDQM 03/04/2024 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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Cannabidiol impurity J CRS now available

EDQM 02/04/2024 Strasbourg, France

The standard cannabidiol impurity J CRS that is described in the monograph on Cannabidiol (3151) is now available for users under catalogue code Y0002436. More information on how to order is available on the EDQM website.

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Revised Regulation for the Ozone-Depleting Substances

EDQM 28/03/2024 Strasbourg, France

Regulation (EU) 2024/590 on substances that deplete the ozone layer entered into force on 11 March 2024. The rules governing the placing on the market and use of ozone-depleting substances (ODSs) for essential laboratory and analytical uses have now changed. Under the new regulation, standards...

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1 new Ph. Eur. reference standard and 15 replacement batches released in February 2024

EDQM 01/03/2024 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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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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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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