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European Pharmacopoeia | News | 07 April 2020 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) seeks feedback on its new general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36).
Certification of suitability (CEP) / Procedure of certification (general) | Notification | 07 April 2020 | Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 32.2 before 30 June 2020. More information in document PA/PH/CEP (20) 17.
News | 07 April 2020 | Strasbourg, France
EDQM / All activities | News | 06 April 2020 | Strasbourg, France
The EDQM will be closed starting Friday 10 April 2020, and will reopen on Tuesday 14 April 2020.
EDQM / All activities | News | 06 April 2020 | Strasbourg, France
The EDQM’s core activities include the provision of documentary and physical (reference) standards to ensure the quality of medicines and their ingredients. Availability of and access for patients to quality medicines is more important than ever in the context of the current COVID-19 pandemic.
Reference Standard / Collection & Catalogue | News | 03 April 2020 | Strasbourg, France
The EDQM announces the availability of 18 replacement batches for European Pharmacopoeia (Ph. Eur.) reference standards.
Paediatric Formulary | News | 03 April 2020 | Strasbourg, France
The European Paediatric Formulary (PaedF) Working Party, in this exceptional situation, wishes to serve pharmacists by compiling existing knowledge on paediatric formulations for active substances under investigation as well as known authorised medicinal products. Information on paediatric formulations of active substances used in clinical trials but also experimentally in clinical practice...
Reference Standard / Collection & Catalogue | News | 02 April 2020 | Strasbourg, France
The EDQM will soon be launching a new and improved WebStore for Reference Standards, following up on its most recent customer satisfaction survey.
European Pharmacopoeia / Ph. Eur. Commission | News | 31 March 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. Eur. Commission decided to make an exception for these substances and keep the specific elemental...
Certification of suitability (CEP) / Nitrosamines | News | 27 March 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 APIs with regards nitrosamine formation, published on the EDQM Website (EDQM request October 2019).
European Pharmacopoeia / Announcements | News | 24 March 2020 | Strasbourg, France
Are you ready to comply with the new European Pharmacopoeia (Ph. Eur.) revised text on extraneous agent testing in immunological veterinary medicinal products (IVMPs)? The approach to extraneous agent testing in IVMPs has recently been updated and manufacturers of these products are required to comply with new standards from 1 July 2020. The EDQM is organising two free webinar sessions to help Ph...
European Pharmacopoeia / Animal testing | News | 24 March 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 the Ph. Eur.’s toxicity testing requirements for tetanus vaccines for human and veterinary use.
EDQM / All activities | News | 19 March 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 that there may still be delays in processing requests.
Pharmaceutical care / Policy support | News | 18 March 2020 | Strasbourg, France
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 framework for promoting and implementing the concept of pharmaceutical care in health systems at national...
Products and Services | News | 18 March 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