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With its Decree No. 98 dd. 09.02.2012 the Ministry of Healthcare
of Ukraine approved the procedure for cooperation between the
Department for Development of the Pharmaceutical Sector of the
Healthcare Industry of the Ministry of Healthcare of Ukraine and
the State Enterprise "State Expert Centre of the Ministry of
Healthcare of Ukraine" in the course of state registration of
medicinal products and conduct of clinical drug trials. This Decree
regulates the procedure of cooperation between the Department for
Development of the Pharmaceutical Sector of the Healthcare Industry
the Ministry of Healthcare of Ukraine (the Department), the State
Enterprise "State Expert Centre of the Ministry of Healthcare
of Ukraine" (the Centre), the Administrative Services Centre
of the Ministry of Health of Ukraine "One Stop Solution"
(Administrative Services Centre) and the Commission for state
registration and conduct of clinical trials of the Ministry of
Healthcare of Ukraine.
By Order of the Ministry of Healthcare of Ukraine No. 158 dd.
07.03.2012 the current version of the above Regulation was amended
based on the comments of market participants. According to the
above amendments the interaction process was simplified. Thus, the
requirement to obtain a decision of the Qualification Commission
and the State Registration Commission were excluded.
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