In terms of the Act No.362/2011 Coll. on the medicinal products and medical devices the Pharmacopoeia Department at the State Institute for Drug Control ensures the cooperation at the elaboration of European Pharmacopoeia and compilation of the Slovak Pharmaceutical Codex.
European Pharmacopoeia 9th edition
The European Pharmacopoeia (Ph. Eur.) defines requirements for the qualitative and quantitative composition of medicines, the tests to be carried out on medicines and on substances and materials used in their production. The monographs of the Pharmacopoeia are applicable throughout the 37 member states of the Council of Europe and the European Union.
It covers active substances, excipients and preparations of chemical, animal, human or herbal origin, homoeopathic preparations and homoeopathic stocks, antibiotics, as well as dosage forms and containers. It also includes texts on biologicals, blood and plasma derivatives, vaccines and radiopharmaceutical preparations. According to the Act No. 663/2006 Coll. (Convention on the Elaboration of a European Pharmacopoeia) the Ph. Eur. and its requirements became the official standards applicable within the Slovak Republic. These quality standards therefore have an impact on the quality of medicinal products and substances also in the Slovak Republic.
The legal framework and the mission of the European Pharmacopoeia are available at the website of the European Directorate for the Quality of Medicines and HealthCare ( https://www.edqm.eu/en/news/european-pharmacopoeia ).
Since January 1st 2017 the European Pharmacopoeia 9th edition is valid. The European Pharmacopoeia is being published in a 3-year cycle with thrice-yearly supplements. Users are recommended to consult the index of the most recent supplement to ensure they use the latest versions of the monographs and general chapters.
Slovak Pharmaceutical Codex
defines technical requirements for preparation, quality assessment, labeling, storage, prescription and dispensation of extemporaneous preparations and stock preparations and intermediate products. The first edition was issued in 2006, with supplement in 2007. After revision in October 2015, the second edition has been issued. The second edition consists of two parts:
Annex 1
60 monographs of galenic products and 19 monographs of active substances, excipients and intermediate products. In addition in contains updated list of Reagents and eight tables with useful information for pharmacists (relationship between relative density and ethanol content, isotonisation of aqueous solutions, degree of coloration of liquids, recommended doses of active substances for adults and for children, etc.). The last table represents the list of Ph. Eur. monographs – Latin, English and Slovak names)
Annex 2
Methods and reagents for second identification testing of active substances and excipients used in pharmacies for preparation of extemporaneous preparations and stock preparations.
