Council for europe portal
Language : en Search
Choose language

Search

9 results
  • Ph. Eur. 10th Edition: KEY FIGURES EUROPEAN PHARMACOPOEIA The new edition of the official Pharmacopoeia, valid 2020-2023 Applicable in 38 European countries NORTH AMERICA 2 observer states SOUTH AMERICA 2 observer states EUROPE 38 member states and the EU, as well as 6 observer states
  • Ph. Eur. 10th Edition: NEW MONOGRAPHS AND TEXTS (COMPARED TO 9.0) New substances and finished products New general chapters 7 finished products and 114 substances (active and excipients), including 17 patent-protected substances 12 texts adopted, including 8 methods of analysis
  • The basic purpose of a pharmacopoeia (from the Greek word φαρμακοποιΐα, which literally means “medicine-making”) is to ensure that medicines are safe and of good quality. Historically, medicines were produced in community pharmacies, but today almost all medicines in developed countries are produced industrially:
  • Held in a different country every year since 1996, the European Organ Donation Day (EODD) has been organised by the Council of Europe to help raise public awareness on the need for organ donation and to promote the principle of voluntary and non-remunerated donation.
  • Presentation of the European Network of Official Medicines Control Laboratories: history, main figures and list of activities.
  • The Certification of suitability to the monographs of the European Pharmacopoeia, or so-called CEP procedure, is one out of three alternative options that can be used by a manufacturer to demonstrate that the quality of their substance is suitably controlled by the respective monograph of the European Pharmacopoeia (Ph. Eur.), and is in compliance with the current regulatory requirements. Alternatively, for an active substance, the same data can be filed either in an Active Substance Master File (ASMF), to be submitted to each competent authority, or in the relevant part of the quality dossier of the marketing authorisation application (MAA).
  • The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a directorate of the Council of Europe. Its origins date back to 1964, when the international Convention on the Elaboration of a European Pharmacopoeia was adopted by the Council of Europe with the vision of creating a common European Pharmacopoeia.
  • The EDQM is responsible for establishing, monitoring and distributing the official Reference Standards (RS) of the European Pharmacopoeia (Ph. Eur.), which provide the legal and scientific basis for the control of the quality of medicines in Europe and worldwide.
  • PHARMACEUTICALS AND PHARMACEUTICAL CARE The Biological Standardisation, Network of Official Medicines Control Laboratories (OMCL) and HealthCare Department (DBO) is responsible for the Secretariat of the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and its three subordinate committees of experts