The European Pharmacopoeia (Ph. Eur.) is the primary source of official quality standards for medicines and their ingredients in Europe. Ph. Eur. standards provide a scienti?c basis for the quality control of a product throughout its life cycle, supporting the pharmaceutical industry and healthcare systems.
As laid down in the Council of Europe Convention on the Elaboration of a European Pharmacopoeia and in European Union and national pharmaceutical legislation, these standards are legally binding. They become mandatory on the same date in all states parties to the convention.
Key facts about the 11th Edition
- New edition, legally binding in 39 European countries as of 1 January 2023 and applied in more than 130 countries worldwide.
- Continuously updated and modernised to meet users’ needs.
- The 11th Edition of the Ph. Eur. contains:
- 2 469 monographs (including dosage forms);
- 386 general texts (including general monographs and methods of analysis);
- and more than 2 800 descriptions of reagents.
- Note that the 11th Edition print version will no longer contain change marks in revised and corrected texts
- ISBN 9789287191052 – Hardback – Three volume