YULIA, RAHAWATI (2023) PENEGAKAN HUKUM TERHADAP PEREDARAN OBAT TRADISIONAL YANG TIDAK MEMILIKI IZIN EDAR OLEH PENYIDIK PEGAWAI NEGERI SIPIL BADAN POM DI PROPINSI LAMPUNG. Masters thesis, UNIVERSITAS LAMPUNG.
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Abstrak (Berisi Bastraknya saja, Judul dan Nama Tidak Boleh di Masukan)
Undang-Undang Kesehatan Nomor 36 tahun 2009 mengamanahkan bahwa obat tradisional harus aman, berkhasiat/ bermanfaat, bermutu, dan terjangkau. setiap produk yang akan diedarkan harus memiliki izin edar untuk menjamin keamanan dan khasiat sediaan obat tradisional. Akan tetapi masih banyak ditemukan kasus obat tradisional tanpa izin edar. oleh karena itu perlu dilakukan analisa proses penegakan hukum terhadap pelanggaran obat tradisional tanpa izin edar oleh penyidik pegawai negeri sipil Badan POM di Propinsi Lampung. Penelitian ini dilakukan dengan metode normatif empiris dan pendekatan teori Lawren M Friedman yaitu penegakan hukum dipengaruhi faktor struktur, substansi dan budaya hukum. Badan POM yang secara struktur berdasarkan Peraturan Pemerintah Nomor 80 Tahun 2017 diberi keweangan melakukan pengawasan peredaran obat tradisional dan penegakan hukum terhadap pelanggaran yang dilakukan, terus melakukan sinkronisasi secara struktur maupun substansi. Hasil penelitian menunjukan dari proses pengawasan yang dilakukan Badan POM tahun 2019-2022 terdapat 160 sarana distribusi yang tidak memenuhi ketentuan (dari total 396 sarana yang diperiksa) yaitu menjual produk obat tradisional tanpa izin edar. Sanksi administratif diberikan kepada sarana yang melakukan pelanggaran selama proses pengawasan. Sedangkan proses penegakan hukum merupakan ultimum remedium atau pilihan terakhir yang dilakukan setelah pelaku usaha mengulangi kesalahan mengedarkan obat tradisional tanpa izin edar setelah dilakukan pembinaan. Data penindakan pada tahun 2021 menunjukkan 3 kasus dilanjutkan ke proses projustisia (dari 9 kasus obat tradisional tanpa izin edar). Masih beredarnya obat tradisonal tanpa izin edar tentu tidak lepas dari budaya aparat penegak hukum, pelaku usaha maupun masyarakat. Badan POM terus berupaya melakukan advokasi kepada stake holder, bimbingan teknis kepada pelaku usaha dan penyuluhan kepada masyarakat agar peredaran obat tradisional tanpa izin edar bisa diatasi dengan optimal. Kata kunci: Faktor Penegak Hukum, Badan POM, PPNS, Tindak Pidana Obat Tradisional Tanpa Izin Edar Health Law No. 36 of 2009 mandates that traditional medicines must be safe, efficacious/beneficial, of high quality, and affordable. every product to be distributed must have a distribution permit to guarantee the safety and efficacy of traditional medicinal preparations. However, there are still many cases of traditional medicines without distribution permits. Therefore it is necessary to analyze the law enforcement process against violations of traditional medicines without distribution permits by investigators from National Agency of Drug and Food Control civil servants in Lampung Province. This research was conducted using empirical normative methods and the theoretical approach of Lawrence M Friedman, namely law enforcement is influenced by structural, substance and legal culture factors. National Agency of Drug and Food Control, which is structurally based on Government Regulation Number 80 of 2017 is given the authority to supervise the circulation of traditional medicines and enforce the law against violations committed, continues to synchronize both structurally and substance. The results showed that from the supervision process carried out by the National Agency of Drug and Food Controlin 2019-2022, there were 160 distribution facilities that did not meet the requirements (out of a total of 396 facilities examined), namely selling traditional medicinal products without distribution permits. Administrative sanctions are given to facilities that commit violations during the supervision process. Meanwhile, the law enforcement process is an ultimum remedium or last resort that is carried out after business actors repeat the mistake of distributing traditional medicines without a distribution permit after coaching. Enforcement data for 2021, 3 cases will proceed to the pro-justisia process (out of 9 cases of traditional medicines without distribution permits). The circulation of traditional medicines without a distribution permit cannot be separated from the culture of law enforcement officials, business people and society. National Agency of Drug and Food Control continues to make efforts to advocate for stake holders, provide technical guidance to business actors and educate the public so that the distribution of traditional medicines without a distribution permit can be handled optimally. Key Word: Law Enforcement Factors, National Agency of Drug and Food Control, Civil Servant Investigator, Traditional Medicine Crime Without Distribution Permit
| Jenis Karya Akhir: | Tesis (Masters) |
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| Subyek: | 300 Ilmu sosial > 340 Ilmu hukum |
| Program Studi: | Fakultas Hukum > Magister Hukum S2 |
| Pengguna Deposit: | 2301943099 . Digilib |
| Date Deposited: | 13 Apr 2023 07:35 |
| Terakhir diubah: | 13 Apr 2023 07:35 |
| URI: | http://digilib.unila.ac.id/id/eprint/70760 |
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