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Certification of suitability (CEP) | News | 03 September 2020 | Strasbourg, France
The EDQM has concluded its investigation following reports that paracetamol manufactured by a specific company holding a certificate of suitability could be contaminated with the impurity 4-chloroaniline (PCA).
Products and Services | News | 02 September 2020 | Strasbourg, France
The EDQM announces the availability of 5 new reference standards and 21 replacement batches for Ph. Eur. reference standards, released in August 2020
Certification of suitability (CEP) / Nitrosamines | News | 17 August 2020 | Strasbourg, France
In October 2019, the EDQM requested companies holding CEPs to perform a risk assessment of their chemically synthesised APIs with regard to potential nitrosamine formation, using quality risk management principles. It was highlighted that the factors to be taken into account were outlined in the dedicated Questions and Answers documents available on the EMA and CMDh websites.
EDQM / All activities | News | 17 August 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 / Biological reference preparation (BRP) | News | 14 August 2020 | Strasbourg, France
The Ph. Eur. Commission adopted the replacement batch (batch 2) of the Pertussis Toxin Biological Reference Preparation by correspondence in May 2020.  
Transfusion / Blood Quality Management system (B-QM) | News | 11 August 2020 | Strasbourg, France
In light of the ongoing COVID-19 pandemic, the EDQM/Council of Europe and the European Commission (EC) have decided to modify the conference “Keeping up with Reality and Quality: A Challenge for European Blood Establishments” to a fully online format that will take place from Tuesday 27 to Thursday 29 October 2020.
Products and Services | News | 05 August 2020 | Strasbourg, France
6 new reference standards and 20 replacement batches released in July 2020 The EDQM announces the availability of: 6 new European Pharmacopoeia (Ph. Eur.) reference standards and 20 replacement batches for Ph. Eur. reference standards.
Certification of suitability (CEP) / Procedure of certification (general) | News | 23 July 2020 | Strasbourg, France
Supplement 10.3 of the Ph. Eur is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of January 2021, and to follow the instructions given in the document.
Certification of suitability (CEP) / CEP revision | News | 21 July 2020 | Strasbourg, France
Following experience gained since the introduction of the revised EDQM Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2, 7R corr) in January 2019, this announcement is intended to clarify a couple of items.
Patient & Consumer Protection / Cosmetics | News | 20 July 2020 | Strasbourg, France
The experts of the European Committee for Cosmetics and Consumer Health (CD-P-COS) held a virtual meeting on 22 and 23 June to define steps for advancing consumer protection in Europe and for reinforcing cross-border co-operation and independent cosmetics testing. The meeting also marked the 10th anniversary of the Network of Official Cosmetics Control Laboratories (OCCLs), which supports...
Certification of suitability (CEP) / Procedure of certification (general) | Certificate of suitability (CEP) | 16 July 2020 | Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 32.3 before 30 September 2020.
European Pharmacopoeia / Public enquiry | News | 15 July 2020 | Strasbourg, France
All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 32.3 is 30 September 2020.
European Pharmacopoeia / Nitrosamines | News | 10 July 2020 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) published its new general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36) for a 3-month public consultation in Pharmeuropa 32.2. The closing date for public comments was 30 June 2020.
Certification of suitability (CEP) / API | News | 10 July 2020 | Strasbourg, France
Following the publication of an article in the Dutch newspaper Nieuwe Rotterdamsche Courant Handelsblad (NRC) concerning an impurity (4-chloroaniline) in the active substance paracetamol manufactured by a specific company which holds a certificate of suitability, the EDQM is actively working with the company and other stakeholders to better understand the potential impact of this impurity and the...
European Pharmacopoeia / Ph. Eur. Commission | News | 07 July 2020 | Strasbourg, France
The 167th session of the European Pharmacopoeia (Ph. Eur.) Commission on 23 June 2020 was the first ever to be held online, due to the COVID-19 pandemic. This unprecedented meeting successfully brought together over 130 members of the Ph. Eur. Commission, its 60 groups of experts and working parties and the scientific Secretariat, to ensure the continuity of the work of the Ph. Eur. was not...