European Pharmacopoeia 11.0

The European Pharmacopoeia (Ph. Eur.) is a single reference work for the quality control of medicines. The official standards it contains provide a scientific basis for quality control during the entire life cycle of a product.

These standards are legally binding - as laid down in the Council of Europe Convention on the Elaboration of a European Pharmacopoeia and in EU and national pharmaceutical legislation. Ph. Eur. quality standards become mandatory on the same date in all States Parties to the convention.

The 11th Edition at a glance

• Legally binding in 39 European countries and applied in more than 120 countries worldwide.

• Provides new and revised texts.

• Delivers crucial information for European markets earlier than any other Pharmacopoeia.

• The 10th Edition (including Supplement 10.5) contains 2447 monographs (including dosage forms), 378 general texts (including general monographs and methods of analysis) and about 2800 descriptions of reagents.

Initial release and updates

The 11th version of the European Pharmacopoeia (Ph.Eur.) is now available. The latest edition comprises some updated monographs which will be implemented on 01 January 2023. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia - holders) are required to align their specifications and thus the respective CEPs with the new monographs. This may result in the associated dossier having to be updated and reported to the EDQM (European Directorate for the Quality of Medicines & HealthCare). For this purpose, the revisions of the monographs have been divided into two categories and presented in a list available on the EDQM website.

Case A

The specifications of the substances belonging to this classification have to be revised.

If the respective specification does not include the addition "current version of the monograph", notification of the new specification is required with the next CEP update request.

If this passage is included, the monograph can be implemented without updating the specification.

Case B

Monographs belonging to this category require notification to the EDQM in any case.

The updated dossier showing that the new data of the revised monographs have been adopted must be submitted within three months. CEP holders are encouraged to update Module 1 and 3 and provide explanatory information accordingly. After receipt of the new data, the EDQM will check it within three months and then inform the CEP holder of the results of this evaluation. Revision of CEPs is not excluded.

The 11th Edition of the Ph. Eur. was released in July 2022 and will be updated with eight periodic supplements over the following three years (11.1 to 11.8).

Supplement 11.0 published in July 2022,

Supplement 11.1 published in October 2022 and

Supplement 11.2 published in January 2023.

Print version

The 11th Edition consists of three initial volumes (11.0) complemented by eight non-cumulative supplements (11.1 to 11.8). For the convenience of users, direct access to complementary information (Knowledge Database) is included for each monograph and general chapter through a data matrix code. Available in either English or French, the print version contains a subscription key (EPID code) that allows access to online archives.

Electronic version:

• Completely cumulative versions, bilingual (English and French), with new features and direct access to complementary information (Knowledge Database);

• Access to the European Pharmacopoeia Online website from all recent common operating systems (tablet and smartphone friendly);

• An application fully compatible with recent Windows and Linux operating systems;

• Two installation options for each electronic licence: either individual or shared access (one option to be chosen):

• Individual use: install the application on one computer and on one USB stick, for online or offline use and easy access while on the move or in environments where using the book or the website is not possible or practical;

• Shared use: install the application on one computer or one USB stick, for online or offline use, for example for non-nominative access in university libraries or laboratories.

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