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EDQM / All activities | News | 15 June 2021 | Strasbourg, France
On 26 May 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the Eurasian Economic Commission (EEC) signed a memorandum of understanding.
Certification of suitability (CEP) / Procedure of certification (general) | News | 08 June 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
European Pharmacopoeia / Announcements | News | 07 June 2021 | Strasbourg, France
This virtual training will focus on chemically defined substances and cover all the fundamentals related to the use of the European Pharmacopoeia (Ph. Eur.) and its reference standards, as well as the procedure for Certification of suitability to the monographs of the European Pharmacopoeia (CEP).
Certification of suitability (CEP) / CEP revision | News | 19 May 2021 | Strasbourg, France
The EDQM document “Implementation of policy on elemental impurities in the Certification Procedure” has been revised to reflect that risk assessments have to be performed and suitable controls for elemental impurities should be implemented using the principles of risk management for substances for veterinary use.
Certification of suitability (CEP) / Procedure of certification (general) | News | 06 May 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
News | 29 April 2021 | Strasbourg, France
Following recent investigations demonstrating the mutagenicity of an azido impurity in sartan active substances (APIs) with a tetrazole ring, the EDQM confirms that the CEP holders concerned have already been contacted and have addressed the issue as requested.
News | 21 April 2021 | Strasbourg, France
CEP holders are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.2. The table below lists the substances affected by these revisions and for which a certificate of suitability to the Ph. Eur. monographs (CEP) has been granted.
News | 08 April 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
News | 12 March 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
News | 11 March 2021 | Strasbourg, France
In order to facilitate the acceptance of proposed changes in a timely manner, CEP holders are reminded that the European Directorate for the Quality of Medicines & HealthCare (EDQM) Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2, 7R corr) lists different notifications and associated conditions, and that...
News | 01 March 2021 | Strasbourg, France
The European Pharmacopoeia Commission has revised via a rapid implementation procedure the five “sartan” monographs (Valsartan, Losartan potassium, Candesartan cilexetil, Olmesartan medoximil and Irbesartan); they will enter into force on 1 April 2021 to align them with the CHMP decision on the detection, management and prevention of the presence of N-nitrosamines in “sartan medicinal products” (...
News | 09 February 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
News | 26 January 2021 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) general monograph Pharmaceutical preparations (2619) requires manufacturers of products outside the scope of general chapter 5.20 to control the levels of elemental impurities in products using the principles of risk management.
News | 20 January 2021 | Strasbourg, France
CEP holders are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.1. The table below lists the substances affected by these revisions and for which CEPs have been granted.
News | 18 January 2021 | Strasbourg, France
Supplement 10.5 of the European Pharmacopoeia (Ph. Eur) is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on 1 July 2021, and to follow the instructions given below.