State Enterprise “Ukrainian Scientific Pharmacopoeia Centre for Quality of Medicinal Products”

Опубліковано 22.05.2019 о 13:19

State Enterprise “Ukrainian Scientific Pharmacopoeia Centre for Quality of Medicinal Products” (hereinafter – SE “Pharmacopoeia Centre”)

The SE “Pharmacopoeia Centre” main tasks are:

– designing and updating the State Pharmacopoeia of Ukraine (SPU);

– creation, certification and distribution of pharmacopoeia reference standards of SPU.

The first edition of the State Pharmacopoeia of Ukraine was developed by SE “Pharmacopoeia Centre” and had been introduced in 2001. Today, the SE “Pharmacopoeia Centre” together with the State Service of Ukraine on Medicines and Drugs Control has developed a second edition of SPU, which was put into effect by the Order of the Ministry of Health of Ukraine January 1, 2016, and it’s fully harmonized with the European Pharmacopoeia (EF). March 14, 2018, by the Order of the Ministry of Health of Ukraine No.476 was put into effect Annex No.2 to SPU’s 2nd edition).

In 2012 Ukraine acquired membership status of the European Pharmacopoeia Commission with the right to vote.

Furthermore, Ukraine, represented by SE “Pharmacopoeia Centre”, is a formal member of the US Pharmacopoeia, with the right to vote. The SE “Pharmacopoeia Centre” has cooperation agreements with the US Pharmacopoeia (2015) and British Pharmacopoeia (March 2017).

About creation, certification and distribution of pharmacopoeia reference standards of SPU

The National System of Pharmaceutical reference standards (PRS), established by SE “Pharmacopoeia Centre”, is the basis for entire quality control system. It is constantly updated and enhanced based on research and certification of European reference standards of medicinal products, provided by European Pharmacopoeia Commission. Only Pharmacopoeia Authority has the right to certify and distribute PRS. The official status of PRS comes from the fact that the SE “Pharmacopoeia Centre” is a government facility.

Today, SE “Pharmacopoeia Centre” is a powerful research center with more than 100 employees, of whom 15 PhD (6 of them associate professors and senior research assistants), 7 doctors of sciences (3 of them professors and 1 corresponding member of the National Academy of Sciences of Ukraine).

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