18 replacement batches of Ph. Eur. reference standards released in March 2020

EDQM 03/04/2020 Strasbourg, France

New releases: Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Change of price Change of EDQM storage/shipping conditions Removal of unit quantity in RS leaflets Change in the policy for withdrawing reference standards from sale Current...

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Coming soon: new EDQM Reference Standards webstore

EDQM 02/04/2020 Strasbourg, France

The EDQM will soon be launching a new and improved WebStore for Reference Standards, following up on its most recent user satisfaction survey. With this improved platform, ordering Reference Standards from the EDQM will be faster and easier than before. Among other improvements, users will be...

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Update on the European Pharmacopoeia policy on elemental impurities – Excipients of natural origin

EDQM 31/03/2020 Strasbourg, France

In January 2017, the EDQM published an update on the European Pharmacopoeia (Ph. Eur.) policy on elemental impurities in which the special case of excipients of natural origin was highlighted. At the time, and based on feedback gathered from stakeholders during workshops and conferences, the Ph....

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Deadline extension to all CEP holders to complete step 1 Risk Assessments regarding presence of nitrosamines (now 31 July 2020)

EDQM 27/03/2020 Strasbourg, France

The EDQM recognises that due to the impact of the global outbreak of COVID-19, many CEP holders are encountering significant challenges in completing the work within the timelines previously announced in the EDQM request to CEP holders to perform a risk evaluation of their chemically synthesised...

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European Pharmacopoeia on tetanus vaccines – Rationalising toxicity testing requirements

EDQM 24/03/2020 Strasbourg, France

At its 165th session (November 2019), the European Pharmacopoeia (Ph. Eur.) Commission adopted 16 revised monographs on tetanus vaccines, following a re-assessment of toxicity testing requirements. The revisions include the suppression of three tests and the harmonisation, as far as possible, of...

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COVID-19 – How to contact the EDQM

EDQM 19/03/2020 Strasbourg, France

Due to the measures implemented by the French government in its fight against the COVID-19 pandemic, the EDQM will, until further notice, only be able to answer queries through its Online HelpDesk. We will continue to do our utmost to provide you with the best possible service, but please note...

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New Council of Europe resolution to promote pharmaceutical care in Europe

EDQM 18/03/2020 Strasbourg

A new Council of Europe resolution on the implementation of pharmaceutical care for the benefit of patients and health services has been adopted by the Committee of Ministers of the Council of Europe to improve medication use and the quality of care across Europe. The resolution defines a...

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COVID-19 - Processing and shipment of orders

EDQM 18/03/2020 Strasbourg, France

Due to the global impact of COVID-19, there have been disruptions to flights as well as restrictions on the fulfilment of services by designated courier companies. Limitations on deliveries and extra precautions, such as quarantine and restricted capacity of customs are also causing some delays. ...

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EDQM laboratory obtains ISO 17025:2017 accreditation

EDQM 13/03/2020 Strasbourg, France

The EDQM Laboratory successfully obtained accreditation for the 2017 version of the ISO 17025 standard from the Belgian accreditation organisation BELAC in February 2020, confirming the validity of the results generated for its Ph. Eur. Reference Standards. The certificate can be downloaded here....

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Impact of COVID-19 outbreak on the EDQM Certificate of Suitability (CEP) procedure

EDQM 13/03/2020 Strasbourg, France

The EDQM would like to inform CEP holders of the impact of the COVID-19 outbreak on activities related to the CEP procedure. With regards to sending CEPs, due to issues experienced in shipping/delivering CEPs in some zones considered at risk, the EDQM is contacting the relevant CEP holders in...

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New European Pharmacopoeia general chapter on Balances – Last opportunity to comment

EDQM 09/03/2020 Strasbourg, France

In January 2020, the European Pharmacopoeia (Ph. Eur.) launched a public consultation on a new general chapter on Balances (2.1.7). This important general chapter is limited to balances used for analytical purposes and as such is the basis of every analytical procedure described in the European...

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Shutdown of European Pharmacopoeia 9th Edition

EDQM 06/03/2020 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) 9th Edition has been obsolete since 1 January 2020. Consequently, the 9th Edition online and all previous versions, including the Ph. Eur. archives for 9th Edition clients, have no longer been accessible since 1 March 2020. The Ph. Eur. 10th Edition and its...

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“Meet the World Pharmacopoeias” Symposium

EDQM 05/03/2020 Strasbourg, France

The EDQM organised the one-day “Meet the World Pharmacopoeias” Symposium on 20 February 2020 at the EDQM premises in Strasbourg, after the 11th International Meeting of World Pharmacopoeias (IMWP), which was also hosted at its premises. This symposium gave representatives of world pharmacopoeias...

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4 new reference standards and 19 replacement batches released in February 2020

EDQM 04/03/2020 Strasbourg, France

New releases: New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Change of EDQM storage/shipping conditions Change in the policy for withdrawing reference standards from sale Information for Indian users Shipments to...

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EDQM events scheduled in April: decision expected in the coming days

EDQM 04/03/2020

As every year, the EDQM is organising a number of events to connect people and share knowledge and expertise. Given the growing public health concerns around the COVID-19 outbreak, the EDQM may have to postpone some of its events or offer remote participation, as a measure to protect the health...

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EDQM website search engine deactivated

EDQM 02/03/2020 Strasbourg, France

The EDQM regrets to inform its users that the search engine on its website has been deactivated and is currently unavailable for technical reasons. We are aware of this recurring issue and are working on a long-term solution. We therefore request that our users refrain from contacting the EDQM...

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World Pharmacopoeias move towards increased global co-operation

EDQM 21/02/2020 Strasbourg, France

At the 11th International Meeting of the World Pharmacopoeias (IMWP) co-hosted by the WHO and the EDQM in Strasbourg (France), national and regional pharmacopoeias brought forward initiatives to strengthen their co-operation as a way to improve public health outcomes for patients. Following up on...

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Pharmeuropa Volume 32 No 1, January 2020

EDQM 12/02/2020 Strasbourg, France

Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 32.1 before 31 March 2020. More information in document PA/PH/CEP (20) 10

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Recommendations to stakeholders on plasma supply management

EDQM 11/02/2020 Strasbourg, France

The EDQM has published the recommendations resulting from the International Symposium on Plasma Supply Management organised in co-operation with the European Commission on 29 and 30 January 2019. In recent years, the global use of and demand for plasma for fractionation have grown and this trend...

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European Pharmacopoeia welcomes its 39th member state, Albania

EDQM 10/02/2020 Strasbourg, France

On 9 February 2020, the Convention on the Elaboration of a European Pharmacopoeia entered into force in Albania, making the quality standards for medicines published in the European Pharmacopoeia (Ph. Eur.) legally binding throughout the country. The accession of a new member to the convention...

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