European Pharmacopoeia
The European Pharmacopoeia contains binding quality requirements for active substances, excipients, and medicinal products. It is a publication of the Council of Europe (CoE), published by the European Directorate for the Quality of Medicines & HealthCare (EDQM), in Strasbourg. The pharmacopoeia is used by, for example, the pharmaceutical industry, pharmaceutical wholesalers, pharmacies, and medicines control authorities.
In Finland, the Finnish Medicines Agency (Fimea) acts as the national pharmacopoeia authority.
The European Pharmacopoeia can be ordered from the EDQM Online Store.
Guidelines for using the Pharmacopoeia
Interpreting the European Pharmacopoeia often requires reading several texts in parallel. Guidance on correct interpretation of monographs and texts is provided in the chapter General Notices, which describes the general principles for using other pharmacopoeia texts.
When interpreting chapters and monographs, in addition to the substance/finished product monograph, general monographs must also be considered, even if they are not explicitly referenced in each text. A list of general monographs and their application guidelines is presented in the text General Monographs.
The edition and issue of the European Pharmacopoeia in which it was last updated (e.g., 01/2023: 2303) is mentioned at the beginning of each text. Changes compared to the previous version are marked in the texts. The online service of the European Pharmacopoeia also allows viewing previous and future versions of each text.
Additional instructions for both technical use and content interpretation can be found on the European Pharmacopoeia website.
We also recommend reviewing supplementary material available on Pharmeuropa Online.