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BPOM Regulations and Responsibilities in The Case of Medicines Containing Ethylene Glycol And Diethylene Glycol Silvia, Devi; Pitta Allagan, Tiurma Mangihut
Eduvest - Journal of Universal Studies Vol. 4 No. 5 (2024): Journal Eduvest - Journal of Universal Studies
Publisher : Green Publisher Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.59188/eduvest.v4i5.1370

Abstract

This study aims to find out two problems, namely how is the regulation, role and responsibility of BPOM in the case of drugs containing EG and DEG?; and how is BPOM's responsibility for the legal protection of consumers who consume these drugs? To answer this, researchers apply normative legal studies with secondary data and use qualitative analysis with deductive thinking to draw conclusions. The results of the study stated that there is a legal vacuum in the regulation of BPOM where there is no regulation regarding sanctions if BPOM issues a distribution permit for dangerous products. The role of BPOM in the case of the circulation of drugs containing EG and DEG is in accordance with its function as a product supervisor either before or after circulation, imposing sanctions on business actors, namely revoking distribution permits for harmful products as its authority is regulated in PP 80 of 2017. Preventive legal protection is not implemented properly by BPOM while repressive protection is carried out by reporting and participating in investigations with the police, business actors who distribute drugs with these ingredients.
PENANAMAN MODAL ASING PENGANGKATAN BENDA MUATAN KAPAL TENGGELAM (BMKT) DI INDONESIA Riang Borot, Ursula Kristanti; Pitta Allagan, Tiurma Mangihut
UNES Law Review Vol. 5 No. 1 (2022)
Publisher : Universitas Ekasakti

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.31933/unesrev.v5i1.279

Abstract

In 2021, the government start discussing licensing for foreign investors to search for sunken ship cargo objects (BMKT) under Indonesian waters. This study focuses on normative juridical research by reviewing regulations regarding foreign investment in the lifting of sunken cargo objects (BMKT) in Indonesia and permits for trying to lift sunken cargo objects (BMKT) in the regions. The results obtained are that the regulations have not been specifically regulated, for foreign investment itself it is still running in accordance with the applicable general investment regulations, but specifically for foreign investment in the Lifting of Submerged Ships (BMKT) it is still not optimal and business licensing in The regional government for the Lifting of Sunken Ships (BMKT) for foreign investment is also still not optimally regulated, but Government Regulation No. 6 of 2021 shows that the role of local governments in providing business permits is quite significant through the regional apparatus of the Investment and Integrated Services Agency. One Gate, as well as local governments can provide business licensing matters in accordances with the needs of the region