Posts Tagged ‘Ph.Eur’

European Pharmacopeia:

Thursday, February 4th, 2010

The Ph.Eur is recognised as the only official Pharmacopeia in Europe and is used for international trade. There are 19 observer countries and the World Health Organisation (WHO). It is presented in English and French. Directives 2001/83/EC, 2003/63/EC and 2001/82/EEC make mandatory the Ph.Eur monographs for quality specifications, Quality Control (QC) and terminology.  Raw material preparations, dosage forms, containers must comply with the Ph.Eur requirements where they exist. Certification is considered by regulators to be the preferred option. Harmonisation at an international level between the JP, EP and USP is progressing, though slowly. 45 monographs have been harmonised to date, though the basis for harmonisation can be cumbersome.