[{"_1":2,"_117":-5,"_118":-5},"loaderData",{"_3":4,"_28":29,"_30":31},"root",{"_5":6,"_7":-5,"_8":9},"locale","id","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","cf64cacc-0276-4d90-b639-31d825381a0b","regulationData",{"_36":33,"_37":38,"_113":114,"_115":116},"regulation_id","overview",{"_39":40,"_41":42,"_43":44,"_45":46,"_47":48,"_49":50,"_51":52,"_53":54,"_59":60,"_61":62,"_66":67,"_71":72,"_73":74,"_75":76,"_77":78,"_79":-5,"_80":81,"_82":83,"_84":-5,"_85":86,"_87":88,"_89":83,"_90":91,"_92":93,"_94":95,"_96":97,"_98":99,"_100":101,"_102":103,"_104":105,"_106":107,"_108":109,"_110":-5,"_111":112},"title","Peraturan Badan Pengawas Obat dan Makanan Nomor 30 Tahun 2023 tentang Pedoman Klaim Khasiat Obat Bahan Alam","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 30 Tahun 2023","number","30","year","2023","published_date","2023-11-03","effective_date","2023-11-10","status_id","3611a577-44a0-41ad-986d-7457e14f52ff","status",{"_6":52,"_55":56,"_57":58},"name","Berlaku","description","Peraturan yang masih berlaku dan memiliki kekuatan hukum yang mengikat","type_id","6f5779f5-e2ea-448d-8bb0-b22517233239","type",{"_6":60,"_55":63,"_64":65},"Peraturan Badan Pengawas Obat dan Makanan","short_name","Peraturan BPOM","subjects",[68],{"_6":69,"_55":70,"_57":-5},"10e70ff8-158d-4e9e-849e-554938c706d9","Pelayanan Kesehatan","tags",[],"location","Badan Pengawas Obat dan Makanan","place_of_enactment","Jakarta","theme","Pedoman Klaim Khasiat Obat Bahan Alam","subject_matter","abstract","\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n


2023
Peraturan Badan Pengawas Obat dan Makanan NO. 30, BN 2023 (892); 43 hlm
Peraturan Badan Pengawas Obat dan Makanan TENTANG Pedoman Klaim Khasiat Obat Bahan Alam
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 10 November 2023. \n \n

","regulatory_relationship","(-)","scope_and_parties","policy_content","

Latar Belakang dan Tujuan: Peraturan ini disusun untuk memastikan keamanan, khasiat, dan mutu obat bahan alam serta melindungi masyarakat dari klaim khasiat yang tidak objektif dan menyesatkan. Tujuannya adalah memberikan kepastian dan transparansi bagi pelaku usaha dalam mengajukan klaim khasiat produk saat registrasi, serta menjadi acuan evaluasi bagi Badan POM.

Ketentuan Substansial: Peraturan ini mengatur kewajiban pelaku usaha untuk mencantumkan klaim khasiat pada penandaan obat bahan alam saat registrasi. Klaim harus didukung oleh pembuktian empiris dan/atau ilmiah. Pedoman klaim khasiat meliputi prinsip, jenis, pembuktian, dokumen pendukung, dan contoh klaim. Pelaku usaha bertanggung jawab atas kelengkapan dan kebenaran dokumen pendukung klaim. Badan POM dapat melakukan evaluasi ulang klaim sesuai perkembangan ilmu pengetahuan.

","transitional_provisions","1. Klaim khasiat yang telah dicantumkan sebelum berlakunya Peraturan Badan ini, harus menyesuaikan dengan ketentuan dalam Peraturan Badan ini paling lama 24 (dua puluh empat) bulan terhitung sejak Peraturan Badan ini diundangkan.","sanctions","revokes",[],"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

No.892, 2023 BPOM. Drug Efficacy Claims. Guidelines.

REGULATION OF THE FOOD AND DRUG CONTROL AGENCY
NUMBER 30 OF 2023
CONCERNING
GUIDELINES FOR EFFICACY CLAIMS OF HERBAL MEDICINE

BY THE GRACE OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG CONTROL AGENCY,

\n\n \n \n

Considering:

that to ensure the safety, efficacy, and quality of herbal medicine and to protect the public from herbal medicine efficacy claims that are not objective, incomplete, and misleading, it is necessary to regulate guidelines for herbal medicine efficacy claims comprehensively;
that based on the considerations as referred to in letter a, and to implement Article 126 paragraph (4) of Government Regulation Number 5 of 2021 concerning the Implementation of Risk-Based Business Licensing, it is necessary to stipulate a Regulation of the Food and Drug Control Agency concerning Guidelines for

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