[{"_1":2,"_123":-5,"_124":-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","0ff7e363-0e70-4e2a-a703-0719ff4c9935","regulationData",{"_36":33,"_37":38,"_119":120,"_121":122},"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,"_72":73,"_74":75,"_76":77,"_78":79,"_80":81,"_82":83,"_84":85,"_86":87,"_88":89,"_90":91,"_92":93,"_94":95,"_102":-5,"_103":-5,"_104":-5,"_105":-5,"_106":107,"_112":-5,"_113":-5,"_114":-5,"_115":-5,"_116":-5,"_117":118},"title","Peraturan Badan Pengawas Obat dan Makanan Nomor 9 Tahun 2024 tentang Pedoman Tindak Lanjut Hasil\r\nPengawasan Obat, Bahan Obat, Narkotika, Psikotropika,\r\nPrekursor, dan Zat Adiktif","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 9 Tahun 2024","number","9","year","2024","published_date","2024-05-27","effective_date","2024-06-07","status_id","3611a577-44a0-41ad-986d-7457e14f52ff","status",{"_55":52,"_56":57,"_58":59},"id","name","Berlaku","description","Peraturan yang masih berlaku dan memiliki kekuatan hukum yang mengikat","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],{"_55":70,"_56":71,"_58":-5},"23186465-8acf-4b27-a795-2d4eddc93459","Standar & Pedoman Teknis","tags",[],"location","Badan Pengawas Obat dan Makanan","place_of_enactment","Jakarta","theme","Pedoman Tindak Lanjut Hasil\r\nPengawasan Obat, Bahan Obat, Narkotika, Psikotropika,\r\nPrekursor, dan Zat Adiktif","subject_matter","Peraturan ini mengatur Pedoman tindak lanjut pengawasan Obat, Bahan Obat\r\nNarkotika, Psikotropika, Prekursor, dan Zat Adiktif wajib\r\nmenjadi acuan bagi Petugas dalam melaksanakan tugas\r\npengawasan.","abstract","\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n

PEDOMAN - TINDAK LANJUT - HASIL PENGAWASAN - OBAT - BAHAN OBAT - NARKOTIKA - PSIKOTROPIKA - PREKURSOR - ZAT ADIKTIF
2024
Peraturan Badan Pengawas Obat dan Makanan NO. 9, BN 2024 (308); 43 hlm
Peraturan Badan Pengawas Obat dan Makanan TENTANG Pedoman Tindak Lanjut Hasil\r\nPengawasan Obat, Bahan Obat, Narkotika, Psikotropika,\r\nPrekursor, dan Zat Adiktif
ABSTRAK:	\n \n bahwa pengawasan secara komprehensif terhadap obat,\r\nbahan obat, narkotika, psikotropika, dan prekursor\r\ndilaksanakan untuk mencegah terjadinya penyimpangan\r\npada saat pemasukan, pembuatan, dan peredaran\r\nsehingga dapat dipastikan telah memenuhi standar\r\ndan/atau persyaratan keamanan, khasiat, dan mutu \n PP Nomor 5 Tahun 2021; Perpres Nomor 80 Tahun 2017; Peraturan BPOM Nomor 21 Tahun 2020 sebagaimana telah diubah dengan Peraturan BPOM Nomor 13 Tahun 2022; Peraturan BPOM Nomor 19 Tahun 2023 \n Peraturan ini mengatur Pedoman tindak lanjut pengawasan Obat, Bahan Obat\r\nNarkotika, Psikotropika, Prekursor, dan Zat Adiktif wajib\r\nmenjadi acuan bagi Petugas dalam melaksanakan tugas\r\npengawasan. \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 07 Juni 2024. \n Pada saat Peraturan Badan ini mulai berlaku, Peraturan Badan\r\nPengawas Obat dan Makanan Nomor 19 Tahun 2020 tentang\r\nPedoman Tindak Lanjut Pengawasan Obat dan Bahan Obat\r\n(Berita Negara Republik Indonesia Tahun 2020 Nomor 813),\r\ndicabut dan dinyatakan tidak berlaku. \n 43 hlm; hlm 1 sd 10 batang tubuh, hlm 11 sd 43 lampiran \n \n

","regulatory_relationship","Peraturan ini mencabut: 1. Peraturan Badan Pengawas Obat dan Makanan Nomor 19 Tahun 2020 tentang Pedoman Tindak Lanjut Pengawasan Obat dan Bahan Obat (Berita Negara Republik Indonesia Tahun 2020 Nomor 813).","scope_and_parties","","policy_content","

Peraturan ini bertujuan untuk memperbarui pedoman tindak lanjut hasil pengawasan terhadap obat, bahan obat, narkotika, psikotropika, prekursor, dan zat adiktif. Pengawasan dilakukan untuk memastikan keamanan, khasiat, dan mutu produk serta mencegah penyimpangan dalam pemasukan, pembuatan, dan peredaran. Peraturan ini menggantikan peraturan sebelumnya yang dianggap tidak sesuai dengan perkembangan hukum dan teknologi. Badan Pengawas Obat dan Makanan memiliki fungsi pengawasan sebelum dan selama produk beredar. Kebijakan ini mengatur kewajiban petugas dalam melaksanakan pengawasan, termasuk pembinaan, sanksi administratif, dan rekomendasi hasil pengawasan. Pengawasan meliputi pemasukan, pembuatan, peredaran, iklan, uji klinik, dan penerapan farmakovigilans.

","transitional_provisions","1. Tindak lanjut hasil pengawasan terhadap pelanggaran di bidang Obat, Bahan Obat, Narkotika, Psikotropika, Prekursor, dan Zat Adiktif yang sedang berproses sebelum berlakunya Peraturan Badan ini, tetap diproses berdasarkan Peraturan Badan Pengawas Obat dan Makanan Nomor 19 Tahun 2020 tentang Pedoman Tindak Lanjut Pengawasan Obat dan Bahan Obat.","sanctions","1. Pelanggaran terhadap peraturan ini dapat dijatuhi sanksi administratif maupun pidana. 2. Sanksi administratif dapat berupa teguran tertulis, penangguhan usaha, pencabutan izin, atau pembatalan izin. 3. Sanksi pidana dapat berupa pidana kurungan atau penjara.","revokes",[96],{"_97":98,"_99":100,"_36":101},"text","Peraturan BPOM No. 19 Tahun 2020tentangPedoman Tindak Lanjut Pengawasan Obat dan Bahan Obat","link","https://peraturan.bpk.go.id/Details/181783/peraturan-bpom-no-19-tahun-2020","e6150db9-d566-474e-8af2-383a37f33edd","revoked_by","partially_revokes","partially_revoked_by","amends","amended_by",[108],{"_97":109,"_99":110,"_36":111},"Peraturan BPOM No. 19 Tahun 2025tentangPerubahan atas Peraturan Badan Pengawas Obat dan Makanan Nomor 9 Tahun 2024 tentang Pedoman Tindak Lanjut Hasil Pengawasan Obat, Bahan Obat, Narkotika, Psikotropika, Prekursor, dan Zat Adiktif","https://peraturan.bpk.go.id/Details/326087/peraturan-bpom-no-19-tahun-2025","89c57d29-14a7-4d74-bb9c-f8cb50eb8fb2","partially_amends","partially_amended_by","establishes","established_by","constitutional_review","is_verified",false,"english_excerpt","\n

REGULATION OF THE FOOD AND DRUG CONTROL AGENCY
NUMBER 9 OF 2024
CONCERNING
GUIDELINES FOR FOLLOW-UP ON SUPERVISION OF DRUGS, DRUG INGREDIENTS,
NARCOTICS, PSYCHOTROPICS, PRECURSORS, AND ADDICTIVE SUBSTANCES

BY THE GRACE OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG CONTROL AGENCY,

\n\n \n \n \n \n \n \n \n \n

Considering:

that comprehensive supervision of drugs, drug ingredients, narcotics, psychotropics, and precursors is carried out to prevent irregularities during import, manufacture, and distribution so that it can be ensured that they meet safety, efficacy, and quality standards and/or requirements;
that supervision of addictive substances is carried out to prevent labeling and advertising irregularities so that the public is protected from health risks related to the use of addictive substances;
that the regulation regarding follow-up on drug and drug ingredient supervision as stipulated in the Regulation of the Food and Drug Control Agency Number 19 of 2020 concerning Guidelines for Follow-Up on Drug and Drug Ingredient Supervision is no longer in accordance with legal needs and the development of science and technology, so it needs to be replaced;
that based on the provisions of Article 3 paragraph (1) letter d of Presidential Regulation Number 80 of 2017 concerning the Food and Drug Control Agency, the Food and Drug Control Agency has the function of carrying out pre-market and post-market supervision duties;
that based on the considerations as referred to in letters a, b, c, and d, it is necessary to stipulate a Regulation of the Food and Drug Control Agency concerning Guidelines for Follow-Up on Supervision of Drugs, Drug Ingredients, Narcotics, Psychotropics, Precursors, and Addictive Substances;

In view of:

Government Regulation Number 5 of 2021 concerning the Implementation of Risk-Based Business Licensing (State Gazette of the Republic of Indonesia Year 2021 Number 15, Supplement to the State Gazette of the Republic of Indonesia Number 6617);
Presidential Regulation Number 80 of 2017 concerning the Food and Drug Control Agency (State Gazette of the Republic of Indonesia Year 2017 Number 180);
Regulation of the Food and Drug Control Agency Number 21 of 2020 concerning the Organization and Working Procedures of the Food and Drug Control Agency (State Gazette of the Republic of Indonesia Year 2020 Number 1002) as amended by Regulation of the Food and Drug Control Agency Number 13 of 2022 concerning Amendments to Regulation of the Food and Drug Control Agency Number 21 of 2020 concerning the Organization and Working Procedures of the Food and Drug Control Agency (State Gazette of the Republic of Indonesia Year 2022 Number 629);
Regulation of the Food and Drug Control Agency Number 19 of 2023 concerning the Organization and Working Procedures of Technical Implementation Units at the Food and Drug Control Agency (State Gazette of the Republic of Indonesia Year 2023 Number 611);

DECIDES:

\n\n \n \n \n \n \n \n

To stipulate:

REGULATION OF THE FOOD AND DRUG CONTROL\nMAKANAN CONCERNING GUIDELINES FOR FOLLOW-UP ON SUPERVISION OF DRUGS, DRUG SUBSTANCES, NARCOTICS, PSYCHOTROPICS, PRECURSORS, AND ADDICTIVE SUBSTANCES.

Article 1

In this Agency Regulation, the following shall mean:

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