[{"_1":2,"_128":-5,"_129":-5},"loaderData",{"_3":4,"_28":29,"_30":31},"root",{"_5":6,"_7":-5,"_8":9},"locale","en","session","ENV",{"_10":11,"_12":13,"_14":15,"_16":17,"_18":19,"_20":21,"_22":23,"_24":25,"_26":27},"APP_ENV","production","APP_URL","https://veritask.ai","GA_MEASUREMENT_ID","G-X1BV3QBZEM","META_PIXEL_ID","4698743733686194","TIKTOK_PIXEL_IDS","D8A3HTBC77U9J3L243V0","CLARITY_PROJECT_ID","wn9rn7xb4l","AMPLITUDE_API_KEY","74a0c7cc1509a379d3647ec140dd375","MIDTRANS_CLIENT_KEY","Mid-client-hwjEU5pmwAKVMbIA","MIDTRANS_SNAP_URL","https://app.midtrans.com/snap/snap.js","routes/$locale",{"_5":6},"routes/$locale.search-engine.regulation.$regulationId",{"_32":33,"_34":35},"regulationId","e6150db9-d566-474e-8af2-383a37f33edd","regulationData",{"_36":33,"_37":38,"_124":125,"_126":127},"regulation_id","overview",{"_39":40,"_41":42,"_43":44,"_45":46,"_47":48,"_49":50,"_51":52,"_53":54,"_60":61,"_62":63,"_67":68,"_75":76,"_77":78,"_79":80,"_81":82,"_83":-5,"_84":85,"_86":87,"_88":-5,"_89":90,"_91":92,"_93":94,"_95":96,"_97":98,"_105":106,"_107":108,"_109":110,"_111":112,"_113":114,"_115":116,"_117":118,"_119":120,"_121":-5,"_122":123},"title","Peraturan Badan Pengawas Obat dan Makanan Nomor 19 Tahun 2020 tentang Pedoman Tindak Lanjut Pengawasan Obat dan Bahan Obat","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 19 Tahun 2020","number","19","year","2020","published_date","2020-07-20","effective_date","2020-07-22","status_id","89192b77-602e-484c-89df-4fd3166b732a","status",{"_55":52,"_56":57,"_58":59},"id","name","Tidak Berlaku","description","Peraturan yang sudah tidak berlaku karena dicabut, diubah, atau habis masa berlakunya","type_id","6f5779f5-e2ea-448d-8bb0-b22517233239","type",{"_55":61,"_56":64,"_65":66},"Peraturan Badan Pengawas Obat dan Makanan","short_name","Peraturan BPOM","subjects",[69,72],{"_55":70,"_56":71,"_58":-5},"10e70ff8-158d-4e9e-849e-554938c706d9","Pelayanan Kesehatan",{"_55":73,"_56":74,"_58":-5},"52ab02bc-b4c7-47db-becc-c90c58185c43","Standar & Pedoman Teknis","tags",[],"location","Badan Pengawas Obat dan Makanan","place_of_enactment","Jakarta","theme","Pedoman Tindak Lanjut Pengawasan Obat dan Bahan Obat","subject_matter","abstract","\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n


2020
Peraturan Badan Pengawas Obat dan Makanan NO. 19, BN.2020/No. 813, peraturan.go.id : 9 hlm.
Peraturan Badan Pengawas Obat dan Makanan TENTANG Pedoman Tindak Lanjut Pengawasan Obat dan Bahan Obat
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 22 Juli 2020. \n \n

","regulatory_relationship","Peraturan ini mencabut: 1. Keputusan Kepala Badan Pengawas Obat dan Makanan Nomor HK.04.1.23.09.10.9269 Tahun 2010 tentang Pedoman Tindak Lanjut Hasil Pengawasan Penerapan Cara Pembuatan Obat Yang Baik di Industri Farmasi; 2. Keputusan Kepala Badan Pengawas Obat dan Makanan Nomor HK.04.1.35.07.12.4394 Tahun 2012 tentang Pedoman Tindak Lanjut Hasil Pengawasan Narkotika, Psikotropika, dan Prekursor.","scope_and_parties","policy_content","

Latar Belakang dan Tujuan: Peraturan ini bertujuan untuk menjamin mutu, khasiat, dan keamanan obat serta bahan obat, dan mencegah penyimpangan dalam pengelolaan selama peredaran. BPOM diberi kewenangan untuk memberikan sanksi administratif sesuai peraturan perundang-undangan.

Ketentuan Substansial: Peraturan ini mengatur pembinaan teknis dan sanksi administratif sebagai tindak lanjut pengawasan. Pengawasan dilakukan terhadap fasilitas produksi, distribusi, pelayanan kefarmasian, dan sistem elektronik farmasi. Sanksi administratif dapat berupa peringatan, penghentian sementara, pembekuan, atau pencabutan izin. Pembinaan teknis dilakukan jika ditemukan pelanggaran minor atau mayor yang tidak signifikan. Peraturan ini juga mengatur koordinasi antara BPOM dengan kementerian/lembaga terkait dan pemerintah daerah.

","transitional_provisions","1. Pengenaan tindak lanjut hasil pengawasan terhadap pelanggaran yang sedang berproses sebelum berlakunya Peraturan Badan ini tetap diproses berdasarkan ketentuan: a. Keputusan Kepala Badan Pengawas Obat dan Makanan Nomor HK.04.1.23.09.10.9269 Tahun 2010 tentang Pedoman Tindak Lanjut Hasil Pengawasan Penerapan Cara Pembuatan Obat Yang Baik di Industri Farmasi; dan b. Keputusan Kepala Badan Pengawas Obat dan Makanan Nomor HK.04.1.35.07.12.4394 Tahun 2012 tentang Pedoman Tindak Lanjut Hasil Pengawasan Narkotika, Psikotropika, dan Prekursor.","sanctions","1. Pelanggaran terhadap peraturan ini dapat dikenai sanksi administratif berupa peringatan, peringatan keras, penghentian sementara kegiatan, pembekuan atau pencabutan izin, dan larangan mengedarkan obat. 2. Sanksi administratif tidak menghapuskan pengenaan sanksi keperdataan dan/atau pidana.","revokes",[],"revoked_by",[99],{"_100":101,"_102":103,"_36":104},"text","Peraturan BPOM No. 9 Tahun 2024 tentang Pedoman Tindak Lanjut Hasil Pengawasan Obat, Bahan Obat, Narkotika, Psikotropika, Prekursor, dan Zat Adiktif","link","https://peraturan.bpk.go.id/Details/291497/peraturan-bpom-no-9-tahun-2024","0ff7e363-0e70-4e2a-a703-0719ff4c9935","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. Follow-up. Supervision. Medicine. Material
Medicine. Guidelines.
No.813, 2020

REGULATION OF THE FOOD AND DRUG CONTROL AGENCY
NUMBER 19 OF 2020
CONCERNING
GUIDELINES FOR FOLLOW-UP ON SUPERVISION OF MEDICINE AND MEDICINAL INGREDIENTS

BY THE GRACE OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG CONTROL AGENCY,

\n\n \n \n

Considering:

that to ensure the quality, efficacy, and safety of medicines and medicinal ingredients, and to prevent irregularities in the management of medicines and medicinal ingredients, during distribution, comprehensive supervision is necessary;
that in accordance with the provisions of Article 4 letter C of Presidential Regulation Number 80 of 2017 concerning the Food and Drug Control Agency, one of the authorities of the Food and Drug Control Agency is to impose administrative sanctions in accordance with the provisions of laws and

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