[{"_1":2,"_119":-5,"_120":-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","2f685a5c-3583-45a0-a5d7-58dbdd7e9487","regulationData",{"_36":33,"_37":38,"_115":116,"_117":118},"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,"_74":75,"_76":77,"_78":79,"_80":81,"_82":-5,"_83":84,"_85":86,"_87":88,"_89":90,"_91":92,"_93":94,"_95":96,"_103":-5,"_104":-5,"_105":-5,"_106":-5,"_107":-5,"_108":-5,"_109":-5,"_110":-5,"_111":-5,"_112":-5,"_113":114},"title","Peraturan Badan Pengawas Obat dan Makanan Nomor 14 Tahun 2022 tentang Penarikan dan Pemusnahan Obat yang Tidak Memenuhi Standar dan/atau Persyaratan Keamanan, Khasiat, Mutu, dan Label","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 14 Tahun 2022","number","14","year","2022","published_date","2022-06-29","effective_date","2022-07-04","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","6f5779f5-e2ea-448d-8bb0-b22517233239","type",{"_6":60,"_55":63,"_64":65},"Peraturan Badan Pengawas Obat dan Makanan","short_name","Peraturan BPOM","subjects",[68,71],{"_6":69,"_55":70,"_57":-5},"10e70ff8-158d-4e9e-849e-554938c706d9","Pelayanan Kesehatan",{"_6":72,"_55":73,"_57":-5},"ba8e8363-834f-45d3-85f2-9308c4bc5c62","Hak & Perlindungan Konsumen","tags",[],"location","Badan Pengawas Obat dan Makanan","place_of_enactment","Jakarta","theme","Penarikan dan Pemusnahan Obat yang Tidak Memenuhi Standar dan/atau Persyaratan Keamanan, Khasiat, Mutu, dan Label","subject_matter","abstract","\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n


2022
Peraturan Badan Pengawas Obat dan Makanan NO. 14, BN.2022/No.647, peraturan.go.id: 21 hlm.
Peraturan Badan Pengawas Obat dan Makanan TENTANG Penarikan dan Pemusnahan Obat yang Tidak Memenuhi Standar dan/atau Persyaratan Keamanan, Khasiat, Mutu, dan Label
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 04 Juli 2022. \n \n

","regulatory_relationship","Peraturan ini mencabut: 1. Peraturan Badan Pengawas Obat dan Makanan Nomor 14 Tahun 2019 tentang Penarikan dan Pemusnahan Obat yang Tidak Memenuhi Standar dan/atau Persyaratan Keamanan, Khasiat, Mutu, dan Label","scope_and_parties","","policy_content","

Latar Belakang dan Tujuan: Peraturan ini bertujuan untuk melindungi masyarakat dari risiko kesehatan akibat peredaran obat yang tidak memenuhi standar dan/atau persyaratan keamanan, khasiat, mutu, dan label. Badan Pengawas Obat dan Makanan (BPOM) memiliki fungsi pengawasan sebelum dan selama obat beredar. Peraturan ini menggantikan peraturan sebelumnya yang dianggap tidak sesuai dengan perkembangan hukum dan teknologi.

Ketentuan Substansial: Peraturan ini mengatur penarikan dan pemusnahan obat yang tidak memenuhi standar. Penarikan dapat berupa penarikan wajib yang diperintahkan oleh Kepala BPOM atau penarikan mandiri yang diprakarsai oleh pemilik izin. Obat yang ditarik diklasifikasikan dalam tiga kelas berdasarkan tingkat risiko kesehatan. Pemilik izin wajib melaporkan pelaksanaan penarikan dan pemusnahan obat kepada BPOM. Publikasi penarikan obat harus dilakukan untuk memberikan informasi kepada masyarakat dan tenaga kesehatan.

","transitional_provisions","1. Penarikan dan Pemusnahan Obat yang tidak memenuhi standar dan/atau persyaratan keamanan, khasiat, mutu, dan label yang sedang dalam proses penarikan dan Pemusnahan sebelum berlakunya Peraturan Badan ini, tetap dilaksanakan berdasarkan Peraturan Badan Pengawas Obat dan Makanan Nomor 14 Tahun 2019 tentang Penarikan dan Pemusnahan Obat yang Tidak Memenuhi Standar dan/atau Persyaratan Keamanan, Khasiat, Mutu, dan Label (Berita Negara Republik Indonesia Tahun 2019 Nomor 778).","sanctions","1. Pemilik Izin yang melanggar ketentuan dikenai sanksi administratif berupa peringatan, peringatan keras, penghentian sementara kegiatan pembuatan Obat, pembekuan atau pencabutan sertifikat CPOB, dan pembekuan atau pencabutan Izin Edar termasuk EUA.","revokes",[97],{"_98":99,"_100":101,"_36":102},"text","Perka BPOM No. 14 Tahun 2019tentangPenarikan dan Pemusnahan Obat Yang Tidak Memenuhi Standar dan/atau Persyaratan Keamanan, Khasiat, Mutu, dan Label","link","https://peraturan.bpk.go.id/Details/224861/perka-bpom-no-14-tahun-2019","1e559d82-6692-4ca4-ac24-32bc96412d76","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.647, 2022

BPOM. Safety Requirements. Efficacy. Quality. Label. Withdrawal and Destruction of Drugs. Does Not Meet Standards. Revocation.

REGULATION OF THE FOOD AND DRUG SUPERVISORY AGENCY
NUMBER 14 OF 2022
CONCERNING
WITHDRAWAL AND DESTRUCTION OF DRUGS THAT DO NOT MEET STANDARDS
AND/OR SAFETY, EFFICACY, QUALITY, AND LABEL REQUIREMENTS

BY THE GRACE OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG SUPERVISORY AGENCY,

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

Considering:

that the public needs to be protected from health risks from the circulation of drugs that do not meet standards and/or safety, efficacy, quality, and labeling requirements;
that based on the provisions of Article 3 paragraph (1) letter d of Presidential Regulation Number 80 of 2017 concerning the Food and Drug Supervisory Agency, the Food and Drug Supervisory Agency has the function of carrying out pre-market supervision and post-market supervision;
that the provisions regarding the withdrawal and destruction of drugs that do not meet standards and/or requirements as regulated in the Regulation of the Food and Drug Supervisory Agency Number 14 of 2019 concerning Withdrawal and Destruction of Drugs that Do Not Meet Standards and/or Safety, Efficacy, Quality, and Label Requirements, are no longer in accordance with the development of legal needs and the development of science and technology in the field of drugs so it needs to be replaced;
that based on the considerations as referred to in letters a, b, and c, it is necessary to stipulate a Regulation of the Food and Drug Supervisory Agency concerning Withdrawal and Destruction of Drugs that Do Not Meet Standards and/or Safety, Efficacy, Quality, and Label Requirements;

In view of:

Presidential Regulation Number 80 of 2017 concerning the Food and Drug Supervisory Agency (State Gazette of the Republic of Indonesia of 2017 Number 180);
Regulation of the Food and Drug Supervisory Agency Number 21 of 2020 concerning the Organization and Working Procedures of the Food and Drug Supervisory Agency (State Gazette of the Republic of Indonesia of 2020 Number 1002);
Regulation of the Food and Drug Supervisory Agency Number 22 of 2020 concerning the Organization and Working Procedures of Technical Implementation Units within the Food and Drug Supervisory Agency (State Gazette of the Republic of Indonesia of 2020 Number 1003) as amended by Regulation of the Food and Drug Supervisory Agency Number 23 of 2021 concerning Amendments to Regulation of the Food and Drug Supervisory Agency Number 22 of 2020 concerning the Organization and Working Procedures of Technical Implementation Units within the Food and Drug Supervisory Agency (State Gazette of the Republic of Indonesia of 2021 Number 1151);

DECIDES:

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