European Pharmacopoeia 11th edition and supplements 11.3 to 11.5

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Author:

European Directorate for the Quality of Medicines & HealthCare

The 11th edition of the European Pharmacopoeia (EP), main volume and supplements 11.3-11.5 is legally binding and details the qualitative and quantitative composition of medicines, the tests to be carried out on medicines, the raw materials used in the production of medicines and on the intermediates of synthesis.

The EP is a single reference work for the quality control of medicines in Europe. All producers of medicines or substances for pharmaceutical use must apply the quality standards of the European Pharmacopoeia for the marketing and use of these products in Europe.

Key features:

• Applicable in 39 European countries and used in over 120 worldwide

• Delivers crucial information earlier than any other Pharmacopoeia

• Provides new and revised text

• vailable in print and electronic versions, with direct access to complementary information (EDQM Knowledge Database).

Publications and implementation dates

• Volume: 11.3 - Publication date: July 2023 - Implementation date: 01 January 2024

• Volume: 11.4 - Publication date: October 2023 - Implementation date: 01 April 2024

• Volume: 11.5 - Publication date: January 2024 - Implementation date: 01 July 2024

Alternative formats

• Electronic Provides access to the cumulative content of the updates (11.0 to 11.5) as well as to the Ph. Eur. online archives until 31 December 2023.

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