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New Powers of State Inspectorate for Quality of Medicines of Ukraine

The Draft Decree of the Cabinet of Ministers of Ukraine ‘As regards to Implementing Changes into the Procedure for State Registration (reregistration) of Medicines' (‘the Draft Decree’- hereinafter) was brought forward on the agenda of the Public Council under the State Inspectorate for Quality of Medicines of Ukraine (‘the State Medicines Service of Ukraine’- hereinafter).

The document envisages incorporation of the powers for state registration/ reregistration of medicines to the competence of the State Medicines Service of Ukraine jointly with the State Enterprise ‘State Expert Centre of the Ministry of Healthcare of Ukraine’.Currently the present procedure is being executed by the Ministry of Healthcare of Ukraine (MoH).

Reportedly, at the meeting of the government the resolution on withdrawal of the State Medicines Service of Ukraine from subordination of MoH of Ukraine and direct coordination of its activities by the Cabinet of Ministers of Ukraine was adopted. At present the text of the corresponding decree has not yet been made public.

On May, 15, 2014, at the meeting of the Public Council of MoH of Ukraine the participants voiced their concerns with non-involvement of the general public to agitation of the changes proposed and stressed the necessity to analyze the Draft Decree and study the European practices of regulation of the present issue.

The prospects of strengthening the role of the State Medicines Service of Ukraine also received negative feedback from specialized associations that act against direct resubordination of the present state body to the Cabinet of Ministers of Ukraine and entrusting one of the bodies with the powers for registering medicines and their simultaneous quality control after their release.

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