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 seventh supplement of the eleventh edition of the European Pharmacopoeia (European Pharmacopoeia 11th Edition, supplement 11.7) has been implemented on April 1st, 2025.
The National pharmacopoeia documents have been updated according to the eleventh edition.
New and deleted texts in Supplement 11.7
New texts
General chapters
- 2.4.35. Extractable elements in plastic materials for pharmaceutical use
- 5.33. Design of experiments
- 5.34. Additional information on gene therapy medicinal products for human use
Monographs
- Enoxaparin sodium injection (3131)
- Etravirine tablets (3122)
- Pirfenidone tablets (3155)
General monographs
- Gene therapy medicinal products for human use (3186)
Herbal drugs and herbal drug preparations
- Australian dodder seed (3189)
- California poppy (3088)
- Cypress oil (3003)
- Grapevine leaf (2667)
- Phyllanthus emblica fruit (3160)
- Walnut leaf (2946)
Radiopharmaceutical preparations and starting materials for radiopharmaceutical preparations
- Lutetium (177Lu) zadavotide guraxetan injection (3170)
Deleted texts
General chapters
- 5.14. Gene transfer medicinal products for human use