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.
The initial release (11.0), published in July 2022, is then updated by eight periodic supplements (11.1 to 11.8) over the following three years. It is available in print
versions (a downloadable version is no longer available). The supplements are non-cumulative in the print versions, but cumulative in the online subscriptions.Print version
- three initial volumes (11.0), followed by eight non-cumulative supplements (11.1 to 11.8);
- now with QR codes for easier linking to the Knowledge database for each monograph and general chapter;
- contains a subscription key (EPID code) giving access to the Ph. Eur. online archives.
Note that the 11th Edition print version will no longer contain change marks in revised and corrected texts.
This print subscription includes the initial release and the first two subsequent supplements (11.0 to 11.2) and includes access to the Ph. Eur. online archives via an EPID subscription code.
|Publications and Implementation Dates|
|11.0||Jul 2022||1 Jan 2023|
|11.1||Oct 2022||1 Apr 2023|
|11.2||Jan 2023||1 Jul 2023|