The Drugs Market Regulation Chamber (CMED) opened yesterday, September 13, 2017, a public consultation regarding resolution proposed, which disposes over the administrative procedures for verification of infractions and application of penalties due to conducts that violates the regulatory norms of the drugs market.
The resolution proposed defines infractions and applicable penalties, also specifying the manner to determine the amount of the fines, applying predefined formulas. The intention is the enhancement of the management and analysis of the administrative procedures, outlining the steps of opening and instruction of sanctioning procedures, as well as the possibility of voluntary compensation prior to the commencement of administrative procedure, and also the subsequent compensation, both important innovations proposed by CMED. Moreover, the resolution also institutionalizes the Conduct Adjustment Agreements to be executed on CMED's own motion or upon requirement of the interested party.
The deadline to present contributions is October 13, 2017, and may be done through the formulary available in this link. The resolution proposal may be consulted in this link.
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