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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