[{"_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","e30dbef1-f1dc-4477-925e-d2341f646362","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,"_72":73,"_74":75,"_76":77,"_78":79,"_80":-5,"_81":82,"_83":84,"_85":-5,"_86":87,"_88":89,"_90":91,"_92":93,"_99":100,"_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 11 Tahun 2020 tentang Kriteria dan Tata Laksana Registrasi Suplemen Kesehatan","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 11 Tahun 2020","number","11","year","2020","published_date","2020-06-11","effective_date","2020-06-12","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],{"_55":70,"_56":71,"_58":-5},"10e70ff8-158d-4e9e-849e-554938c706d9","Pelayanan Kesehatan","tags",[],"location","Badan Pengawas Obat dan Makanan","place_of_enactment","Jakarta","theme","Kriteria dan Tata Laksana Registrasi Suplemen Kesehatan","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. 11, BN.2020/No. 610, peraturan.go.id : 44 hlm.
Peraturan Badan Pengawas Obat dan Makanan TENTANG Kriteria dan Tata Laksana Registrasi Suplemen Kesehatan
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 12 Juni 2020. \n \n

","regulatory_relationship","Peraturan ini mencabut: 1. Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor ΗΚ.00.05.41.1381 Tahun 2005 tentang Tata Laksana Pendaftaran Suplemen Makanan. Peraturan ini mengubah: (-)","scope_and_parties","policy_content","

Peraturan ini bertujuan untuk melindungi masyarakat dari suplemen kesehatan yang tidak memenuhi persyaratan keamanan, manfaat, dan mutu. Badan Pengawas Obat dan Makanan (BPOM) berwenang menerbitkan izin edar produk suplemen kesehatan sesuai dengan persyaratan tersebut. Peraturan ini menggantikan ketentuan sebelumnya yang dianggap tidak sesuai dengan perkembangan ilmu pengetahuan dan teknologi. Kebijakan ini mengatur prosedur registrasi suplemen kesehatan, termasuk registrasi baru, variasi, dan ulang. Pelaku usaha yang terlibat meliputi industri farmasi, industri obat tradisional, usaha kecil obat tradisional, industri pangan, dan importir. Mereka diwajibkan memenuhi persyaratan perizinan dan menerapkan cara pembuatan yang baik. Selain itu, penandaan produk harus mencantumkan informasi lengkap dan tidak menyesatkan. Peraturan ini juga mengatur tentang penggunaan bahan aktif dan tambahan, serta uji stabilitas produk.

","transitional_provisions","1. Pelaku Usaha yang mengajukan permohonan Registrasi sebelum berlakunya Peraturan Badan ini tetap diproses berdasarkan Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor HK.00.05.41.1381 Tahun 2005 tentang Tata Laksana Pendaftaran Suplemen Makanan. 2. Izin Edar Suplemen Kesehatan yang telah diterbitkan sebelum berlakunya Peraturan Badan ini, tetap berlaku sampai dengan berakhirnya masa berlaku Izin Edar dan paling lama 2 (dua) tahun wajib menyesuaikan dengan Peraturan Badan ini.","sanctions","1. Pelaku Usaha yang melanggar Pasal 18 dikenai sanksi administratif berupa: a. peringatan tertulis; b. penarikan produk Suplemen Kesehatan dari peredaran; c. pembatalan proses Registrasi; d. penundaan pelayanan Registrasi produk Suplemen Kesehatan; e. larangan mengajukan permohonan Registrasi Suplemen Kesehatan; dan/atau f. pembatalan Izin Edar.","revokes",[94],{"_95":96,"_97":98},"text","Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor HK.00.05.41.1381 Tahun 2005 tentang Tata Laksana Pendaftaran Suplemen Makanan","link","","revoked_by",[101],{"_95":102,"_97":103,"_36":104},"Peraturan BPOM No. 32 Tahun 2022 tentang Kriteria dan Tata Laksana Registrasi Suplemen Kesehatan","https://peraturan.bpk.go.id/Details/303290/peraturan-bpom-no-32-tahun-2022","3a3a8b4d-49fd-46e5-bcb0-b09c9c5b465a","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

REGULATION OF THE FOOD AND DRUG CONTROL AGENCY
NUMBER 11 OF 2020
ON
CRITERIA AND PROCEDURES FOR REGISTRATION OF HEALTH SUPPLEMENTS

BY THE GRACE OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG CONTROL AGENCY,

Considering:

that to protect the public from health supplements
that do not meet the requirements for safety,
benefits, and quality, it is necessary to regulate the
registration of health supplements;
that in accordance with the provisions of Article 4 of the
Presidential Regulation Number 80 of 2017 concerning the Food and Drug
Control Agency, the Food and Drug Control Agency
is authorized to issue marketing authorizations for
health supplement products in accordance with the requirements
of safety, benefits, and quality;
that the provisions regarding the registration of supplements
health as regulated in the Regulation of the
Head of the Food and Drug Control Agency Number
ΗΚ.00.05.41.1381 of

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