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.Online version:
- fully cumulative versions, bilingual (English and French), with new features and direct access to complementary information (Knowledge database);
- tablet and smartphone friendly;
- compatible with recent versions of Windows, Linux and MacOS;
- direct access to Ph. Eur. online archives included for the duration of the subscription;
- featuring a new tool to toggle off change marks for improved readability and toggle on change marks for visibility of changes (for revised and corrected texts);
- other features: direct links to texts, search query management.
: with the 11th Edition it will no longer be possible to install the application on computers or USB sticks.
This online subscription provides access to the cumulative content of the initial release (11.0) and subsequent updates (11.1 to 11.2) until 31st December 2023, including access to the Ph. Eur. online archives.
|Publication and Implementation Dates|
|11.0||Jul 2022||1 Jan 2023|
|11.1||Oct 2022||1 Apr 2023|
|11.2||Jan 2023||1 Jul 2023|