[{"_1":2,"_124":-5,"_125":-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","eea68e03-5598-4cd0-855e-aafd7c62f851","regulationData",{"_36":33,"_37":38,"_120":121,"_122":123},"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":90,"_91":92,"_93":94,"_101":102,"_103":104,"_105":106,"_107":108,"_109":110,"_111":112,"_113":114,"_115":116,"_117":-5,"_118":119},"title","Peraturan Badan Pengawas Obat dan Makanan Nomor 32 Tahun 2019 tentang Persyaratan Keamanan dan Mutu Obat Tradisional","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 32 Tahun 2019","number","32","year","2019","published_date","2019-10-22","effective_date","2019-10-23","status_id","89192b77-602e-484c-89df-4fd3166b732a","status",{"_6":52,"_55":56,"_57":58},"name","Tidak Berlaku","description","Peraturan yang sudah tidak berlaku karena dicabut, diubah, atau habis masa berlakunya","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","Persyaratan Keamanan dan Mutu Obat Tradisional","subject_matter","abstract","\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n


2019
Peraturan Badan Pengawas Obat dan Makanan NO. 32, BN 2024 (1294); 38 hlm
Peraturan Badan Pengawas Obat dan Makanan TENTANG Persyaratan Keamanan dan Mutu Obat Tradisional
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 23 Oktober 2019. \n \n

","regulatory_relationship","Peraturan ini mencabut Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 12 Tahun 2014 tentang Persyaratan Mutu Obat Tradisional (Berita Negara Republik Indonesia Tahun 2014 Nomor 1200).","scope_and_parties","policy_content","

Peraturan Badan Pengawas Obat dan Makanan ini mengatur persyaratan keamanan dan mutu Obat Tradisional sebagai bagian dari kriteria untuk mendapatkan izin edar. Latar belakangnya adalah bahwa Peraturan Kepala Badan Obat dan Makanan Nomor 12 Tahun 2014 sudah tidak sesuai dengan kebutuhan hukum dan perkembangan ilmu pengetahuan dan teknologi.

Ketentuan substansial mencakup kewajiban Pelaku Usaha untuk menjamin keamanan dan mutu Obat Tradisional yang dibuat, diimpor, dan/atau diedarkan. Persyaratan keamanan dan mutu berlaku untuk Bahan Baku dan Produk Jadi. Persyaratan keamanan dan mutu Bahan Baku mengacu pada Farmakope Herbal Indonesia atau Materia Medika Indonesia, atau standar farmakope negara lain, referensi ilmiah yang diakui, dan/atau data ilmiah yang sahih.

Produk Jadi meliputi Jamu, Obat Tradisional Impor, Obat Tradisional Lisensi, Obat Herbal Terstandar, dan Fitofarmaka, yang dibedakan berdasarkan penggunaan (obat dalam dan obat luar) dan bentuk sediaan. Parameter uji meliputi organoleptik, kadar air, cemaran mikroba, aflatoksin total, cemaran logam berat, keseragaman bobot, waktu hancur, volume terpindahkan, penentuan kadar alkohol, dan/atau pH. Dalam hal Produk Jadi menggunakan bahan tambahan, harus memenuhi persyaratan tambahan yang ditetapkan.

Pendaftar yang persyaratan keamanan dan mutu Obat Tradisionalnya belum diatur dalam Peraturan ini, harus mengajukan permohonan pengkajian kepada Kepala Badan melalui Direktur Standardisasi Obat Tradisional, Suplemen Kesehatan dan Kosmetik.

","transitional_provisions","1. Permohonan registrasi Obat Tradisional yang telah diajukan sebelum berlakunya Peraturan Badan ini, tetap diproses berdasarkan Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 12 Tahun 2014 tentang Persyaratan Mutu Obat Tradisional (Berita Negara Republik Indonesia Tahun 2014 Nomor 1200).\n2. Izin edar Obat Tradisional yang telah ada sebelum berlakunya Peraturan Badan ini, tetap berlaku dan harus menyesuaikan dengan Peraturan Badan ini paling lambat 12 (dua belas) bulan sejak Peraturan Badan ini diundangkan.","sanctions","Pelanggaran terhadap ketentuan dalam Pasal 3 ayat (1), ayat (2) dan/atau Pasal 7 ayat (4) dikenai sanksi administratif berupa:\n1. peringatan tertulis;\n2. penarikan Obat Tradisional dari peredaran;\n3. penghentian sementara kegiatan produksi dan/atau distribusi; dan/atau\n4. pembatalan izin edar.","revokes",[],"revoked_by",[95],{"_96":97,"_98":99,"_36":100},"text","Peraturan BPOM No. 29 Tahun 2023 tentang Persyaratan Keamanan dan Mutu Obat Bahan Alam","link","https://peraturan.bpk.go.id/Details/285065/peraturan-bpom-no-29-tahun-2023","d7981c71-b59f-453e-9933-8d6d5c9730e0","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. Safety. Quality. Traditional medicine. Requirements.
No.1294, 2019

REGULATION OF THE FOOD AND DRUG CONTROL AGENCY
NUMBER 32 OF 2019
CONCERNING
SAFETY AND QUALITY REQUIREMENTS FOR TRADITIONAL MEDICINE

BY THE GRACE OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG CONTROL AGENCY,

\n\n \n \n

Considering:

that the Regulation of the Head of the Food and Drug Agency Number 12 of 2014 concerning Quality Requirements for Traditional Medicine as the implementation of the provisions of Article 6 paragraph (2) of the Minister of Health Regulation Number 7 of 2012 concerning Registration of Traditional Medicine is no longer in accordance with legal needs and the development of science and technology in the field of Traditional Medicine so it needs to be replaced;
that based on the considerations as referred to in letter a, it is necessary to stipulate a Regulation of

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