Penerapan Hukum Terhadap Tindak Pidana dalam Memproduksi/ Mengedarkan Obat-Obatan Kesehatan yang Tidak Memiliki Izin Edar (Studi Putusan No.1169/Pid.Sus/2015/PN.Mdn)

Abstract

Supervision of the specific permits for the distribution of pharmaceutical preparations and pharmaceuticals has a wide and complex aspect of the problem. Therefore a comprehensive supervision system is needed, from the beginning of the process of a product into the territory of a country until the product is circulating in the community. This is intended so that pharmaceutical preparation products and medical devices that enter Indonesia do not cause consequences that can harm consumers. The problem in this study is how the regulations concerning criminal acts of producing, distributing health drugs that do not have marketing permits, how criminal sanctions are against the perpetrators who produce and distribute health drugs that do not have marketing permits, and how to deal with the perpetrators who circulate health medicines that do not have marketing permits. Data collection methods in this study are: Library Research (Library Research). This method is carried out by conducting research on various written reading sources from scholars, namely theoretical books on law, legal magazines, legal journals and also lecture materials and regulations concerning criminal acts. Field Research (Field Research), namely by doing spaciousness in this case the author immediately conducted a study in the Medan District Court by taking a decision relating to the title of the thesis, namely Decision No. 1169 / Pid.Sus / 2015 / PN.Mdn. Legal regulations concerning criminal acts of producing / distributing drugs without marketing authorization are regulated in Article 8 to Article 13 of Law No. 8 of 1999 concerning Consumer Protection, Article 98, Article 108, Article 197 and Article 198 of Law No. 36 of 2009 concerning Health and Government Regulation of the Republic of Indonesia Number 72 of 1998 concerning Safeguarding Pharmaceutical Preparations and Medical Devices. Criminal sanctions against perpetrators who distribute pharmaceutical preparations and medical drugs without permission from BPOM on Decision No. 1169 / Piid.Sus / 2015 / PN.Mdn is imprisonment for 1 (one) year and a fine of Rp.5,000,000, - (Five Million Rupiah), a subsidy of 3 (three) months imprisonment. Efforts to overcome the perpetrators who circulate pharmaceutical preparations and health drugs are: There is cooperation between the government (MOH, POM, police, court, and prosecutor's office) with industry, importers, distributors, hospitals, professional organizations, medical personnel, pharmacies, drug stores, consumers, and also the community. The government must provide guarantees to every citizen to be able to live healthy and facilities that facilitate access to health, including guarantees of quality and quality. Controlling prices of drugs on the market by the government. Providing correct information to the community so as to expand knowledge about drug selection.