Scientific Online Resource System

Annual for Hospital Pharmacy

Role of the list of standard terms in the European Pharmacopoeia for the establishment of the different existing pharmaceutical forms

Rostislav Atanasov, Valentina Belcheva, Evgeni Grigorov


The type and content of pharmacopoeias have changed many times over the years, until in 1964 the first European Pharmacopoeia was introduced under the jurisdiction of the Council of Europe as part of the implementation of the Convention on the Development of a European Pharmacopoeia.

An important section of the European Pharmacopoeia is the list of standard terms. It is drawn up by the Commission of the European Pharmacopoeia, which is part of the European Directorate for the Quality of Medicines and Healthcare (EDQM), at the request of the European Commission, to be used in applications and marketing authorizations and packaging information, in the package leaflet, in the summary of product characteristics and in electronic communications.

The main purpose of the study is to make a detailed analysis of the List of Standard Terms available in Bulgarian, as well as the database of standard terms maintained by the European Directorate for the Quality of Medicines in order to make a comparison between them and to identify the most the common dosage forms in them as well as the most common routes of administration.

The results of the study show that the largest number are the standard terms referring to medicinal products intended for oral administration and injection. And the most common terms for dosage forms are those for solutions and powders. We also found that the most complete and up-to-date source of information on standard terms for medical devices is the database of standard terms maintained by the European Directorate for the Quality of Medicines, as it is constantly updated. Based on these facts, we can say that the European database is the gold standard for compiling lists of standard terms in each Member State of the Commission of the European Pharmacopoeia. The Bulgarian list of standard terms, on the other hand, is not updated often enough, it is recommended that this be done at shorter intervals, as new terms are constantly appearing. This is best done with each release of an updated version of the pharmacopoeia.


list, standard terms, European Pharmacopoeia, pharmaceutical forms

Full Text


Веков, Т., Социална фармация и фармацевтично законодателство, Учебник, МУ-Плевен 2014;

Димитрова, Зл., И. Гетов. Основи на аптечната практика и бизнес, УИ “Св. Кл. Охридски“, София 2008;

Димитрова, Зл., К. Андреевска, С. Георгиев, Д. Димитров. История на фармацията. УИ „Св. Климент Охридски“, 2010, 253 с.

Scarborough, J.; Nutton, V. The Preface of Dioscorides‘ Materia Medica: introduction, translation, and commentary“. Transactions & Studies of the College of Physicians of Philadelphia. 1982;4(3):187–227.

De Vos, P. European Materia medica in historical texts: Longevity of a tradition and implications for future use. Journal of Ethnopharmacology. 2010;132 (1):28-47.

Апостолов, М. История на медицината и социалното дело, С., БАН, 1994

Петрова, Г. и кол. Социална фармация и фармацевтично законодателство, Учебник, ЦМБ, МУ- София, 2017г.

Urdang, G. Pharmacopoeias as Witnesses of World History. Journal of the History of Medicine and Allied Sciences. 1946;1(1):46-70.

European Pharmacopoeia (Ph. Eur.). Background & Mission. European Directorate for the Quality of Medicines & HealthCare (EDQM).

Гетов, И., Е. Насева, Х. Лебанова, Е. Григоров. Фармако-епидемиология, Учебник, Екопринт, С.2013;

Bouin, A-S., M. Wierer. Quality standards of the European Pharmacopoeia. J Ethnopharmacol. 2014:158( Pt B):454-7.

Charton, E. The role of European Pharmacopoeia monographs in setting quality standards for biotherapeutic products. GaBI Journal. 2016;5(4):174-9.

Shorthose, S. Guide to EU Pharmaceutical Regulatory Law. Kluwer Law International B.V., 2017, 832 p.

Rägo, L., B. Santoso. Drug regulation: history, present and future. Drug benefits and risks: international textbook of clinical pharmacology (part 2) 2008:65-77.

Изпълнителна агенция полекарствата. Секция „Информация за фирмите“.

Сербезова, А., В. Маджаров, С. Георгиев. Регулаторни подходи за разрешаване на лекарства за употреба. Теа дизайн ООД, 255 с.



Article Tools
Email this article (Login required)