Tinjauan Yuridis Tindak Pidana Pengedaran Sediaan Farmasi Tanpa Memiliki Izin Edar (Studi Putusan No.46/pid.sus/2023/Pn.Wng)

Abstrak

This research aims to determine the application of criminal sanctions for the distribution of pharmaceutical drug preparations without a distribution permit in accordance with Health Law Number 36 of 2009. Then to find out how to prevent the distribution of medicines without a distribution permit.  This research is normative in nature. The data used in this research is secondary data, obtained by reading literature on laws and regulations and other literature related to the subject. The research results show that distribution and misuse of pharmaceutical preparations without a distribution permit, as regulated in Law No. 36, is a criminal offense. In this case, the Minister of Health has the r|ight to grant d|istr|ibut|ion perm|its. The cond|it|ion for a pharmaceut|ical preparat|ion to be granted a d|istr|ibut|ion perm|it |is that the pharmaceut|ical preparat|ion has passed tests |in terms of qual|ity, safety and eff|icacy of the drug. |In |implement|ing sanct|ions for cr|im|inal acts of d|istr|ibut|ion and m|isuse of pharmaceut|ical preparat|ions w|ithout a distribution permit as regulated in article 106 of Law No. 36 of 2009 concerning Health, it is stated that pharmaceutical preparations and medical devices can only be distributed after obtaining a distribution permit. Marking and information on pharmaceutical preparations and medical devices must meet the requirements for objectivity and completeness.