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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 31st 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 the 1st of 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) / Procedure of certification (general) | News | 10 January 2018 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
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).
Products and Services | News | 02 January 2018 | Strasbourg, France
Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment.
Products and Services | News | 15 December 2017 | Strasbourg, France
The 9.5 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 July 2018.
European Pharmacopoeia / Monograph | News | 14 December 2017 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission has achieved an important milestone in the field of biotherapeutic products at its 159th Session, held in Strasbourg on 21-22 November 2017, with the adoption of the monograph for Infliximab concentrated solution (2928).
European Pharmacopoeia / Animal testing | News | 08 December 2017 | Strasbourg, France
During its 159th plenary session, held in Strasbourg on 21-22 November 2017, the European Pharmacopoeia Commission endorsed the complete suppression of the test for abnormal toxicity from the European Pharmacopoeia (Ph. Eur.).
European Pharmacopoeia / Ph. Eur. Commission | News | 07 December 2017 | Strasbourg, France
The EDQM wishes to inform stakeholders that the monograph for Etanercept (2895) will be published in the Supplement 9.5 of the European Pharmacopoeia and will become effective on 1 July 2018.
European Pharmacopoeia / Ph. Eur. Commission | News | 28 November 2017 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission adopted 11 new monographs at its 159th Session, which took place in Strasbourg on 21-22 November 2017.
European Pharmacopoeia / General text/chapter | News | 24 November 2017 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on the new version of this major general method which has undergone extensive revision.
Transplantation / Organ trafficking | News | 07 November 2017 | Strasbourg, France
The Council of Europe Convention against Trafficking in Human Organs will come into force after ratification by Malta on 07 November 2017. This is the fifth ratification, following those of Albania, Norway, the Republic of Moldova and the Czech Republic, and it triggers the Convention’s entry into force. These five ratifying member states will be bound by the Convention as of 01 March 2018.
Pharmaceutical care / Indicators for the quality | News | 03 November 2017 | Strasbourg, France
The EDQM has just published the final report of its Pharmaceutical Care Quality Indicators Project.