European Pharmacopoeia
The European Pharmacopoeia contains standardised specifications defining the quality of pharmaceutical preparations, their constituents and containers. Itis published by the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe in Strasbourg.
The Finnish Medicines Agency Fimea is the Finnish national authority in pharmacopoeia matters.
The European Pharmacopoeia can be ordered from EDQM Online Store.
Valid version of the European Pharmacopoeia
Pharmacopoeia decisions come into effect every year on the first day of January, April, and July (1.1., 1.4., and 1.7.), and they are published on Fimea's website (in Finnish) about a month before the entry into force date.
The eighth supplement of the eleventh edition of the European Pharmacopoeia (European Pharmacopoeia 11th Edition, supplement 11.8) has been implemented on July 1st, 2025.
The National pharmacopoeia documents have been updated according to the eleventh edition.
New texts in Supplement 11.8
General chapters
- 2.5.44. Capillary isoelectric focusing for recombinant therapeutic monoclonal antibodies
- 5.1.13. Pyrogenicity
Monographs
- Dapagliflozin propylene glycol monohydrate (3137)
- Dapagliflozin propylene glycol tablets (3175)
- Olodaterol hydrochloride (3174)
- Rosuvastatin zinc tetrahydrate (3135)
Dosage forms
- Orodispersible films (3195)
Herbal drugs and herbal drug preparations
- White mulberry leaf (3164)
Homoeopathic preparations
- Iberis amara for homoeopathic preparations (2838)