State Enterprise “Central Laboratory for Drugs Quality Analysis and Medical Products”

The SE “Central Laboratory” was established in 1998 as an official laboratory for state quality control of medicinal products and successfully passed an international inspection in 2009. The SE “Central Laboratory” is considered as a facility that meets the requirements of good pharmaceutical practices for National Pharmaceutical Control Laboratories and has been added to the list of re-qualified quality control laboratories. In 2013, the SE “Central Laboratory” had been reassessed by WHO inspectors who confirmed its status.

The SE “Central Laboratory” is the only laboratory in the system of the State Service of Ukraine on Medicines and Drugs Control and the only one in Ukraine whose full compliance with the European requirements has been confirmed by the group of auditors of the European Directorate for the Quality of Medicines and Healthcare (EDQM). Hence, the SE “Central Laboratory” in 2012 became a full member of the Pan-European Network of Official Medicines Control Laboratories (GEON) and have been granted the status of an OMCL (European Network of Official Medicines Control Laboratories). After Ukraine joining, in March 2013, the European Pharmacopoeia Convention, the SE “Central Laboratory” has automatically become a full member of the OMCL network. Today, the SE “Central Laboratory” is the main laboratory in the system of state control of medicines and analysis, and playing the role of arbitration in evaluating the results, produced by different laboratories.