Medicinal Products

European Pharmacopoeia

The European Pharmacopoeia was established in 1964 with the Convention on the Elaboration of the European Pharmacopoeia under the auspices of the Council of Europe. It is published by the Council of Europe's European Directorate for the Quality of Medicines and HealthCare (EDQM), located in Strasbourg.

The Republic of Croatia has been the signatory of the Convention and Protocol of the Convention on the Elaboration of the European Pharmacopoeia since 1994, committing itself to its application in practice. It participates in the elaboration of the European Pharmacopoeia through the work of its delegation in the European Pharmacopoeia Commission (Ph. Eur. Commission), as well as through the work of its experts in the Commission's working bodies.

The intensive work of European experts results in the publication of a new complete edition of the European Pharmacopoeia every three years, whereas every year three supplements with new, corrected and revised texts.

Many interesting information about the European pharmacopoeia may be found at www.edqm.eu.

The National Pharmaocopoeia Authority (NPA) is one of the groups in the network of interested parties the work of which is coordinated by the European Pharmacopoeia Commission. The role of the National Pharmacopoeia Authority in the Republic of Croatia is performed by the Agency for Medicinal Products and Medical Devices of Croatia (HALMED).

The European Pharmacopoiea with supplements is published according to the following publishing plan:

Edition, supplement Month of publishing Coming into effect
11.0 July 2022 1. 1. 2023
11.1 October 2022 1. 4. 2023
11.2 January 2023 1. 7. 2023
11.3 July 2023 1. 1. 2024
11.4* October 2023 1. 4. 2024
11.5 January 2024 1. 7. 2024
11.6 July 2024 1. 1. 2025
11.7* October 2024 1. 4. 2025
11.8 January 2025 1. 7. 2025
12.0* July 2025 1. 1.2026

*The printed version includes a cumulative list of reagents

The European Pharmacopoeia is available in two forms; as a book or the online version. The book is published in the official languages ​​of the European Pharmacopoeia - English and French. The online version is bilingual and cumulative (each Supplements is combined with the basic edition into a complete version).

The European Pharmacopoeia and its Supplements may be ordered from:

EDQM & HealthCare Publications (European Pharmacopoeia)
7 allée Kastner
CS 30026
F-67081 Strasbourg Cedex 1
France
Phone: +33 (0)3 88 41 30 30
Fax: +33 (0)3 88 41 27 71
e-mail: via EDQM HelpDesk
http://www.edqm.eu (choose Visit the EDQM Store: https://store.edqm.eu/index.html)

Reference material and reference spectra of the European pharmacopoeia may be ordered from:

EDQM & HealthCare
7 allée Kastner
CS 30026
F-67081 Strasbourg Cedex 1
France
Phone: +33 (0)3 88 41 30 30
Fax: +33 (0)3 88 41 27 71
e-mail: via EDQM HelpDesk
https://rsform.edqm.eu/edqm-wizard/order/

On the EDQM website, Certificates of Suitability of active substances to the monographs of the European Pharmacopoeia (CEPs) can also be accessed.

After registration on the EDQM website, the Standard Terms database can be accessed. For additional questions related to Standard Terms, please contact Goran Benković (goran.benkovic@halmed.hr).

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