[{"_1":2,"_122":-5,"_123":-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","bb2c633a-40e6-4460-870b-7e3074213c47","regulationData",{"_36":33,"_37":38,"_118":119,"_120":121},"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,"_99":100,"_101":102,"_103":104,"_105":106,"_107":108,"_109":110,"_111":112,"_113":114,"_115":-5,"_116":117},"title","Peraturan Badan Pengawas Obat dan Makanan Nomor 6 Tahun 2025 tentang Pedoman Uji Stabilitas Suplemen Kesehatan","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 6 Tahun 2025","number","6","year","2025","published_date","2025-02-21","effective_date","2025-03-20","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",[69,72],{"_55":70,"_56":71,"_58":-5},"10e70ff8-158d-4e9e-849e-554938c706d9","Pelayanan Kesehatan",{"_55":73,"_56":74,"_58":-5},"d1f23a35-5540-4151-bb73-e4522722652d","Tata Naskah Kedinasan","tags",[],"location","Badan Pengawas Obat dan Makanan","place_of_enactment","Jakarta","theme","Pedoman Uji Stabilitas 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

Pedoman - Uji Stabilitas - Suplemen Kesehatan
2025
Peraturan Badan Pengawas Obat dan Makanan NO. 6, BN 2025 (207); 19 hlm
Peraturan Badan Pengawas Obat dan Makanan TENTANG Pedoman Uji Stabilitas Suplemen Kesehatan
ABSTRAK:	\n \n bahwa berdasarkan ketentuan Pasal 3 ayat (1) huruf d\r\nPeraturan Presiden Nomor 80 Tahun 2017 tentang\r\nBadan Pengawas Obat dan Makanan, Badan Pengawas\r\nObat dan Makanan menyelenggarakan fungsi\r\npelaksanaan pengawasan sebelum beredar dan\r\npengawasan selama beredar \n Dasar hukum peraturan ini adalah 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 sebagaimana telah diubah dengan Peraturan BPOM Nomor 3 Tahun 2025 \n Peraturan ini mengatur mengenai pedoman uji stabilitas suplemen kesehatan yang berlaku bagi a. Pelaku Usaha dalam memastikan pemenuhan mutu produk jadi Suplemen Kesehatan sebelum diedarkan di wilayah Indonesia; dan \r\nb. Badan Pengawas Obat dan Makanan dalam melakukan evaluasi terhadap pelaksanaan Uji Stabilitas Suplemen Kesehatan yang dilaksanakan oleh Pelaku Usaha dalam rangka registrasi \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 20 Maret 2025. \n 19 hlm; hlm 1 sd 4 batang tubuh, hlm 5 sd 19 lampiran \n \n

","regulatory_relationship","Peraturan ini mengubah:\n1. Ketentuan Pasal 8 Peraturan Badan Pengawas Obat dan Makanan Nomor 32 Tahun 2022 tentang Kriteria dan Tata Laksana Registrasi Suplemen Kesehatan sebagaimana telah diubah dengan Peraturan Badan Pengawas Obat dan Makanan Nomor 15 Tahun 2024.","scope_and_parties","policy_content","

Latar Belakang dan Tujuan: Peraturan ini ditetapkan untuk melindungi masyarakat dari suplemen kesehatan yang tidak memenuhi kriteria mutu dengan mengatur uji stabilitas suplemen kesehatan. Hal ini sejalan dengan fungsi Badan Pengawas Obat dan Makanan dalam pengawasan sebelum dan selama peredaran produk.

Ketentuan Substansial: Peraturan ini menetapkan pedoman uji stabilitas sebagai acuan bagi pelaku usaha dan Badan Pengawas Obat dan Makanan. Pelaku usaha harus memastikan mutu produk sebelum diedarkan, sementara Badan Pengawas melakukan evaluasi terhadap pelaksanaan uji stabilitas. Uji stabilitas harus dilakukan di laboratorium terakreditasi atau laboratorium internal industri yang bersertifikat. Pedoman ini mencakup desain uji stabilitas, evaluasi, dan pernyataan pada penandaan.

","transitional_provisions","1. Pelaku Usaha yang telah melakukan Uji Stabilitas Suplemen Kesehatan sebelum berlakunya Peraturan Badan ini, wajib menyesuaikan dengan ketentuan dalam Peraturan Badan ini paling lambat 1 (satu) tahun 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

REGULATION OF THE FOOD AND DRUG CONTROL AGENCY
NUMBER 6 OF 2025
CONCERNING
GUIDELINES FOR STABILITY TESTING OF HEALTH SUPPLEMENTS

BY THE GRACE OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG CONTROL AGENCY,

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

Considering:

that to protect the public from supplements
health that does not meet the quality criteria, it is necessary
regulate the stability testing of health supplements;
that based on the provisions of Article 3 paragraph (1) letter d
Presidential Regulation Number 80 of 2017 concerning
Food and Drug Supervisory Agency, the Food and Drug Supervisory
Agency carries out the function of
implementation of pre-market supervision and
post-market supervision;
that based on the considerations as
referred to in letters a and b, it is necessary
stipulate a Regulation of the Food and Drug Supervisory Agency
Food on Guidelines for Stability Testing of Supplements
Health;

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