Cabinet finally delegates key chemical registration functions to MOH

Deficiencies in regulatory framework state regulators Kyiv region

Subject of complaint: State Food Safety and Consumer Protection Service (SFSCP Service)
Complaint in brief: On March 22, 2017, the Ukrainian rep office of a worldwide chemicals producer turned to the BOC. The Complainant could not get certificates to extend the term of its disinfectants registration.
Until September 2014, the State Sanitary and Epidemiological Service dealt with the examination, registration and re-registration of such chemicals. After it stopped operations, most of its functions were taken over by the SFSCP Service, according to a Cabinet Resolution. As it turned out, not all of the duties were delegated: the registration and re-registration of disinfectants was left in limbo.
And so, the SFSCP Service refused to re-register, as this function was not within its legal scope The company tried unsuccessfully to draw the attention of the Cabinet of Ministers and the Ministry of Justice to this problem.
In fact, the problem was systemic, affecting not only the Complainant, but also several industries at the same time. The vast majority of disinfectants used in healthcare establishments, in the food industry and restaurant business, including the disinfection of potable water, are imported. Because this issue is not properly regulated, their use in Ukraine is effectively prohibited. 
Actions taken: The BOC investigator studied the legal framework governing the Complainant’s case. He described the company’s problem in letters to the SFSCP Service, to the Ministry of Health, the Ministry of Justice, the Ministry of Agrarian Policy and Food, and the State Regulatory Service. As a result, it turned out that there were several bills that would allow the matter to be resolved, but not one had actually been adopted. Then the investigator sent a letter to the Ministry of Healthcare proposing options so that the Complainant would not have to cease his commercial activity during transition period. For a few months, the investigator also kept in touch with the Cabinet and constantly monitored the status of this problem.
Result achieved: With the encouragement of the Council, the CMU finally assigned the function of the registration and re-registration of disinfectants to the Ministry of Health in March 2018. The entire procedure was simplified compared to the practices of the defunct sanitary and epidemiological service and a systemic problem was successfully resolved. The Complainant was able to extend the validity of permits for its products and resume normal business activities.

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