European Pharmacopoeia / Monograph | News | 31 January 2019 | Strasbourg, France
At its 162nd session, the European Pharmacopoeia (Ph. Eur.) Commission approved a new edition of the Guide for the elaboration and use of monographs on vaccines and immunosera for human use. The Guide provides guidance to experts on the information to be included in Ph. Eur. monographs related to vaccines and sera for human use, and to harmonise the style of the different monographs.
European Pharmacopoeia / Monograph | News | 25 January 2019 | Strasbourg, France
A revised version of the monograph on Oxytetracycline hydrochloride (0198) has been adopted by the European Pharmacopoeia Commission and will be published in the upcoming 10th Edition. This revised version will include impurity F as a specified impurity and will introduce a limit of maximum 1.0% for the sum of impurities D, E and F, changes seen as a temporary solution that would alleviate the...
Products and Services | News | 24 January 2019 | Strasbourg, France
The 9.8 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 July 2019.
Certification of suitability (CEP) / Procedure of certification (general) | News | 23 January 2019 | Strasbourg, France
Supplement 9.8 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 2019, and to follow the instructions given in the document.