European Pharmacopoeia (EP) is the sole guiding document for the quality control of medicines in Europe. It is applicable in 38 European countries and is used in over 100 countries worldwide, covering a broad range of substances including chemical substances, antibiotics, biological products; human and veterinary vaccines; immunologicals; radiopharmaceuticals; herbal drugs; homeopathic preparations and raw materials. The EP includes general chapters, monographs for starting materials, containers, and sutures; it features 268 general methods, each with illustrations or chromatograms, and descriptions of 2210 reagents.
The EP is developed under the terms of the Convention on the Elaboration of a European Pharmacopoeia (European Treaty Series No. 50), signed by the governments of the member states and the European Union. The European Pharmacopoeia Commission, appointed under Article 5 of the Convention, is responsible for the preparation of the EP. The pharmacopoeia plays a significant role in setting standards within Europe and provides expert advice to the World Health Organization, maintaining strong links with leading world pharmacopoeias to ensure the quality of medicines is at the forefront of international discussion.