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2023
Peraturan Badan Pengawas Obat dan Makanan NO. 29, BN 2023 (888); 42 hlm
Peraturan Badan Pengawas Obat dan Makanan TENTANG Persyaratan Keamanan dan Mutu Obat Bahan Alam
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 09 November 2023. \n \n

","regulatory_relationship","Peraturan ini mencabut:\n1. Peraturan Badan Pengawas Obat dan Makanan Nomor 32 Tahun 2019 tentang Persyaratan Keamanan dan Mutu Obat Tradisional\n2. Ketentuan mengenai uji keamanan dan mutu lovastatin atau monakolin K dan citrinin dalam Peraturan Badan Pengawas Obat dan Makanan Nomor 26 Tahun 2018","scope_and_parties","policy_content","Peraturan ini bertujuan untuk melindungi masyarakat dari peredaran obat bahan alam yang tidak memenuhi persyaratan keamanan dan mutu. Peraturan ini menggantikan peraturan sebelumnya yang dianggap tidak sesuai dengan perkembangan ilmu pengetahuan dan teknologi. Kebijakan ini mengatur persyaratan keamanan dan mutu untuk bahan obat bahan alam dan produk jadi, termasuk kewajiban pelaku usaha untuk menjamin keamanan dan mutu produk sebelum dan selama beredar. Persyaratan ini mencakup bahan obat bahan alam yang tercantum dalam farmakope herbal Indonesia atau standar internasional lainnya. Produk jadi meliputi berbagai bentuk sediaan seperti jamu, obat herbal terstandar, dan fitofarmaka, yang harus memenuhi parameter uji tertentu.","transitional_provisions","1. Permohonan registrasi Obat Bahan Alam yang telah diajukan sebelum berlakunya Peraturan Badan ini, tetap diproses berdasarkan Peraturan Badan Pengawas Obat dan Makanan Nomor 32 Tahun 2019.\n2. Izin edar Obat Bahan Alam yang telah ada sebelum berlakunya Peraturan Badan ini, tetap berlaku dan harus menyesuaikan dengan Peraturan Badan ini paling lambat 24 bulan sejak diundangkan.\n3. Ketentuan batas maksimum cemaran etilen glikol dan dietilen glikol pada Obat Bahan Alam dikecualikan dari penyesuaian ini.","sanctions","1. Pelaku Usaha yang melanggar ketentuan dikenai sanksi administratif berupa peringatan tertulis, penarikan, pemusnahan, penghentian sementara kegiatan, pencabutan sertifikat, pembatalan nomor izin edar, pengumuman kepada publik, dan/atau rekomendasi kepada instansi terkait.","revokes",[94,100],{"_95":96,"_97":98,"_36":99},"text","Peraturan BPOM No. 32 Tahun 2019 tentang Persyaratan Keamanan dan Mutu Obat Tradisional","link","https://peraturan.bpk.go.id/Details/285067/peraturan-bpom-no-32-tahun-2019","eea68e03-5598-4cd0-855e-aafd7c62f851",{"_95":101,"_97":102,"_36":103},"Peraturan BPOM No. 26 Tahun 2018 tentang Pelayanan Perizinan Berusaha Terintegrasi secara Elektronik Sektor Obat dan Makanan","https://peraturan.bpk.go.id/Details/219843/peraturan-bpom-no-26-tahun-2018","00e1d49c-4a9e-403c-8a46-2653e6767786","revoked_by",[],"partially_revokes",[],"partially_revoked_by",[],"amends",[],"amended_by",[],"partially_amends",[],"partially_amended_by",[],"establishes",[],"established_by",[],"constitutional_review","is_verified",false,"english_excerpt","\n

STATE GAZETTE
REPUBLIC OF INDONESIA
BPOM. Drug Safety and Quality. Requirements. Revocation.
No.888, 2023

REGULATION OF THE FOOD AND DRUG CONTROL AGENCY
NUMBER 29 OF 2023
CONCERNING
SAFETY AND QUALITY REQUIREMENTS FOR TRADITIONAL MEDICINE

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 the circulation of traditional medicine that does not meet safety and quality requirements and poses a risk to health, it is necessary to comprehensively regulate the safety and quality requirements for traditional medicine;
that Regulation of the Food and Drug Supervisory Agency Number 32 of 2019 concerning Safety and Quality Requirements for Traditional Medicines and provisions regarding safety and quality testing of lovastatin or monacolin K and citrinin in Regulation of the Food and Drug Supervisory Agency Number 26 of 2018

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