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Pengawasan - Farmasi - Pangan Olahan - Masyarakat
2025
Peraturan Badan Pengawas Obat dan Makanan NO. 16, BN 2025 (391); 12 hlm
Peraturan Badan Pengawas Obat dan Makanan TENTANG Pengawasan Sediaan Farmasi dan Pangan Olahan Melalui Peran Serta Masyarakat
ABSTRAK:	\n \n bahwa berdasarkan ketentuan Pasal 427 Peraturan\r\nPemerintah Nomor 28 Tahun 2024 tentang Peraturan\r\nPelaksanaan Undang-Undang Nomor 17 Tahun 2023\r\ntentang Kesehatan serta Pasal 76, Pasal 77, dan Pasal\r\n81 Peraturan Pemerintah Nomor 86 Tahun 2019\r\ntentang Keamanan Pangan, masyarakat dapat berperan\r\nserta dalam pengawasan sediaan farmasi dan pangan\r\nolahan guna mewujudkan pelindungan dari bahaya\r\nyang disebabkan oleh penggunaan sediaan farmasi dan\r\npangan olahan yang tidak tepat dan/atau tidak\r\nmemenuhi standar dan/atau persyaratan \n Dasar hukum peraturan ini adalah UU Nomor 18 Tahun 2012; UU Nomor 17 Tahun 2023; PP Nomor 86 Tahun 2019; PP Nomor 28 Tahun 2024; Perpres Nomor 80 Tahun 2017; Peraturan BPOM Nomor 21 Tahun 2020 sebagaimana telah diubah dengan Peraturan BPOM Nomor 13 Tahun 2022; Pereaturan BPOM Nomor 19 Tahun 2023 sebagaimana telah diubah dengan Peraturan Nomor 3 Tahun 2025 \n Peraturan ini mengatur mengenai peran masyarakat alam pengawasan Sediaan Farmasi dan Pangan Olahan terkait\r\npemenuhan standar dan/atau persyaratan keamanan,\r\nkhasiat/kemanfaatan, mutu, label, penandaan,\r\npromosi, dan/atau iklan. \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 04 Juni 2025. \n 12 hlm; hlm 1 sd 6 batang tubuh; hlm 7 sd 12 lampiran \n \n

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Latar Belakang dan Tujuan: Peraturan ini bertujuan untuk melindungi masyarakat dari sediaan farmasi dan pangan olahan yang tidak memenuhi standar keamanan, khasiat, mutu, label, penandaan, promosi, dan iklan. Pengawasan dilakukan secara terpadu melalui peran serta masyarakat secara partisipatif, kolaboratif, dan edukatif. Hal ini untuk mendukung perdagangan yang jujur dan bertanggung jawab serta meningkatkan daya saing produk.

Ketentuan Substansial: Masyarakat dapat berperan serta dalam pengawasan dengan memberikan informasi atau laporan kepada Kepala Badan Pengawas Obat dan Makanan. Peran serta ini harus dilakukan secara bertanggung jawab dan objektif, tanpa benturan kepentingan. Informasi dapat disampaikan melalui survei, penelitian, atau pengujian laboratorium. Verifikasi dan evaluasi dilakukan oleh Kepala Badan untuk memastikan keabsahan informasi sebelum tindakan lebih lanjut seperti pengumuman publik atau pemberdayaan masyarakat. Pedoman pengawasan disusun untuk memastikan peran serta masyarakat diterapkan secara efektif dan efisien.

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Masyarakat yang melanggar ketentuan Pasal 2 ayat (2) dikenai sanksi sesuai dengan ketentuan peraturan perundang-undangan.

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REGULATION OF THE FOOD AND DRUG CONTROL AGENCY
NUMBER 16 OF 2025
CONCERNING
SUPERVISION OF PHARMACEUTICAL PREPARATIONS AND PROCESSED FOODS THROUGH THE ROLE
OF THE COMMUNITY

BY THE GRACE OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG CONTROL AGENCY,

\n\n \n \n

Considering:

that to protect the public from pharmaceutical preparations and processed foods that do not meet the standards and/or safety, efficacy/benefit, quality, labeling, marking, promotion, and/or advertising requirements, it is necessary to strengthen the integrated pharmaceutical preparation and processed food supervision system through the participatory, collaborative, and educative role of the community;
that the community needs to support the creation of fair and responsible pharmaceutical preparation and processed food trade, as well as increasing the competitiveness of pharmaceutical preparations and processed foods;
tha

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