[{"_1":2,"_123":-5,"_124":-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","f6ccbefe-09e3-4e3b-8d21-912bba93a95d","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,"_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,"_98":99,"_100":101,"_102":103,"_104":105,"_106":107,"_108":109,"_110":111,"_112":113,"_114":115,"_116":-5,"_117":118},"title","Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 5 Tahun 2016 tentang Penarikan dan Pemusnahan Obat Tradisional yang Tidak Memenuhi Persyaratan","short_title","Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 5 Tahun 2016","number","5","year","2016","published_date","2016-03-28","effective_date","2016-04-04","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","c654dbe5-5577-430d-bdbb-99b7df3d9a31","type",{"_6":60,"_55":63,"_64":65},"Peraturan Kepala Badan Pengawas Obat dan Makanan","short_name","Perka 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","Penarikan dan Pemusnahan Obat Tradisional yang Tidak Memenuhi Persyaratan","subject_matter","abstract","\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n


2016
Peraturan Kepala Badan Pengawas Obat dan Makanan NO. 5, BN.2016/No.498, jdih.pom.go.id: 10 hlm.
Peraturan Kepala Badan Pengawas Obat dan Makanan TENTANG Penarikan dan Pemusnahan Obat Tradisional yang Tidak Memenuhi Persyaratan
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Kepala Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 04 April 2016. \n \n

","regulatory_relationship","Peraturan ini mencabut:\n1. Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor HK.03.1.23.02.12.1248 Tahun 2012 tentang Kriteria dan Tata Cara Penarikan Obat Tradisional yang Tidak Memenuhi Persyaratan","scope_and_parties","policy_content","

Latar Belakang dan Tujuan: Peraturan ini ditetapkan untuk melindungi masyarakat dari risiko peredaran obat tradisional yang tidak memenuhi persyaratan keamanan, khasiat/manfaat, mutu, dan penandaan. Peraturan sebelumnya dianggap tidak sesuai dengan situasi dan kondisi terkini, sehingga diperlukan pembaruan.

Ketentuan Substansial: Peraturan ini mengatur kewajiban penarikan dan pemusnahan obat tradisional yang tidak memenuhi persyaratan. Penarikan dilakukan oleh Pemegang Izin Edar berdasarkan hasil pengawasan, termasuk inspeksi dan pengujian. Obat tradisional yang tidak memenuhi persyaratan harus ditarik dari peredaran dan dimusnahkan dengan cara yang tidak mencemari lingkungan. Pemegang Izin Edar juga harus melaporkan penarikan dan pemusnahan kepada Kepala Badan. Selain itu, peraturan ini mengklasifikasikan penarikan menjadi dua kelas berdasarkan jenis pelanggaran yang ditemukan.

","transitional_provisions","(-)","sanctions","1. Pelanggaran terhadap ketentuan dalam Peraturan ini dapat dikenai sanksi administratif berupa peringatan keras, penghentian sementara kegiatan produksi, penghentian sementara kegiatan impor produk yang tidak memenuhi syarat, penghentian pelayanan registrasi produk selama 6 bulan, dan/atau pembatalan izin edar.","revokes",[93],{"_94":95,"_96":97},"text","Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor HK.03.1.23.02.12.1248 Tahun 2012 tentang Kriteria dan Tata Cara Penarikan Obat Tradisional yang Tidak Memenuhi Persyaratan","link","","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

FOOD AND DRUG MONITORING AGENCY
REPUBLIC OF INDONESIA

REGULATION OF THE HEAD OF FOOD AND DRUG MONITORING AGENCY
REPUBLIC OF INDONESIA

NUMBER 5 OF 2016

CONCERNING

WITHDRAWAL AND DESTRUCTION OF TRADITIONAL MEDICINE THAT DOES NOT
MEET THE REQUIREMENTS

BY THE GRACE OF GOD ALMIGHTY

HEAD OF FOOD AND DRUG MONITORING AGENCY
REPUBLIC OF INDONESIA,

\n\n \n \n

Considering:

that the public needs to be protected from the risks of the circulation of traditional medicines that do not meet the requirements of safety, efficacy/benefit, quality, and labeling;
that the Regulation of the Head of the Food and Drug Monitoring Agency Number HK.03.1.23.02.12.1248 of 2012 concerning Criteria and Procedures for Withdrawal of Traditional Medicines that do not meet the requirements is no longer in accordance with the latest situation and conditions;
that based on the considerations as referred to in letters a

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