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Pharmaceutical care / Publications | News | 15 March 2018 | Strasbourg, France
The EDQM has issued its Guidelines on ‘Best Practice for the Automated Dose Dispensing (ADD) Process and Care and Safety of Patients’. ADD is an automated process, which allows one or more medicinal products to be dispensed into a container/pouch for a patient to take at a particular date and time.
Products and Services | News | 12 March 2018 | Strasbourg, France
9 new Ph. Eur. Reference Standards (RS) were released in February 2018
Certification of suitability (CEP) / Procedure of certification (general) | News | 05 March 2018 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
European Pharmacopoeia / Monograph | News | 01 March 2018 | Strasbourg, France
Due to the public health risk associated with histamine contamination, further requirements related to the quality of raw materials have been added to the Raw materials section of the monograph on Products of fermentation (1468).
Transfusion / Legal Framework | News | 22 February 2018 | Strasbourg, France
The Council of Europe’s decision-making body, the Committee of Ministers, adopted Resolution CM/Res(2017)43 on principles concerning haemophilia therapies at the end of 2017.
Reference Standard / Chemical reference standard (CRS) | News | 16 February 2018 | Strasbourg, France
The EDQM announces the availability of a new reference standard: Sodium aminosalicylate dihydrate for equipment qualification CRS 1 replacing the former Amoxicillin trihydrate for performance verification CRS, which will be discontinued as of 1 April 2018.
European Pharmacopoeia / General | News | 16 February 2018 | Mumbai, Inde
The Indian Pharmacopoeia Commission (IPC) and EDQM are pleased to announce their joint symposium on ‘Drug Standards and Regulatory Updates’ on 26 to 27 April in Mumbai, India.
Reference Standard / Chemical reference standard (CRS) | News | 01 February 2018 | Strasbourg, France
Four new elemental impurity chemical reference standards (CRS) are available in the European Pharmacopoeia catalogue: lead solution CRS, cadmium solution CRS, mercury solution CRS and arsenic solution CRS.
Transplantation / Organ trafficking | News | 31 January 2018 | Strasbourg, France
Armenia has signed the Council of Europe Convention against Trafficking in Human Organs on 24 January 2018. The Convention, which is now signed by 21 countries and ratified by 5, identifies various activities constituting human organ trafficking as criminal offences and will come into force on 1 March 2018.
Certification of suitability (CEP) / Certification content of dossier | News | 29 January 2018 | Strasbourg, France
The EDQM has revised the document « Guidance for electronic submissions for Certificates of Suitability (CEPs) applications ». The requirements with regards the format of CEP submissions have been updated
Certification of suitability (CEP) / Procedure of certification (general) | News | 19 January 2018 | Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 30.1 before 31 March 2018.
Certification of suitability (CEP) / Procedure of certification (general) | News | 19 January 2018 | Strasbourg, France
Supplement 9.5 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 1 July 2018, and to follow the instructions given in the document.
European Pharmacopoeia / General text/chapter | News | 18 January 2018 | Strasbourg, France
Revision of the Ph. Eur. general chapters on plasticised PVC materials, following the 159th Commission session (November 2017) of the Ph. Eur. Commission.
Certification of suitability (CEP) / Products with risk of TSE | News | 10 January 2018 | Strasbourg, France
EDQM has revised the guideline "Content of the dossier for a substance for TSE risk assessment". The revision takes into account all recent regulatory changes in the field and a new paragraph has been added with regard to the requirements for raw materials used for medical devices.
European Pharmacopoeia / General | News | 08 January 2018 | Zagreb, Croatia
The EDQM is pleased to announce that registration for the European Pharmacopoeia (Ph. Eur.) training session is now open. The event will take place on 24 to 25 May in Zagreb (Croatia).