[{"_1":2,"_127":-5,"_128":-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","eb2b26a5-3d3a-47d3-a213-22fd08907d2e","regulationData",{"_36":33,"_37":38,"_123":124,"_125":126},"regulation_id","overview",{"_39":40,"_41":42,"_43":44,"_45":46,"_47":48,"_49":48,"_50":51,"_52":53,"_59":60,"_61":62,"_66":67,"_74":75,"_76":77,"_78":79,"_80":81,"_82":-5,"_83":84,"_85":86,"_87":-5,"_88":89,"_90":91,"_92":93,"_94":95,"_102":103,"_104":105,"_106":107,"_108":109,"_110":111,"_112":113,"_114":115,"_116":117,"_118":119,"_120":-5,"_121":122},"title","Peraturan Badan Pengawas Obat dan Makanan Nomor 2 Tahun 2022 tentang Pelaporan Kegiatan Industri Farmasi dan Pedagang Besar Farmasi","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 2 Tahun 2022","number","2","year","2022","published_date","2022-01-07","effective_date","status_id","3611a577-44a0-41ad-986d-7457e14f52ff","status",{"_54":51,"_55":56,"_57":58},"id","name","Berlaku","description","Peraturan yang masih berlaku dan memiliki kekuatan hukum yang mengikat","type_id","6f5779f5-e2ea-448d-8bb0-b22517233239","type",{"_54":60,"_55":63,"_64":65},"Peraturan Badan Pengawas Obat dan Makanan","short_name","Peraturan BPOM","subjects",[68,71],{"_54":69,"_55":70,"_57":-5},"10e70ff8-158d-4e9e-849e-554938c706d9","Pelayanan Kesehatan",{"_54":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","Pelaporan Kegiatan Industri Farmasi dan Pedagang Besar Farmasi","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. 2, BN.2022/No.7, peraturan.go.id: 11 hlm.
Peraturan Badan Pengawas Obat dan Makanan TENTANG Pelaporan Kegiatan Industri Farmasi dan Pedagang Besar Farmasi
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 07 Januari 2022. \n \n

","regulatory_relationship","Peraturan ini mencabut:\n\n1. Peraturan Badan Pengawas Obat dan Makanan Nomor 35 Tahun 2019 tentang Pelaporan Kegiatan Industri Farmasi (Berita Negara Republik Indonesia Tahun 2019 Nomor 1608).","scope_and_parties","policy_content","

Peraturan Badan Pengawas Obat dan Makanan ini mengatur tentang pelaporan kegiatan industri farmasi dan pedagang besar farmasi (PBF) dalam rangka pengawasan obat dan bahan obat yang beredar di Indonesia. Latar belakangnya adalah kebutuhan untuk memastikan keamanan, khasiat, dan mutu obat seiring dengan perkembangan ilmu pengetahuan dan teknologi di bidang pelaporan industri farmasi.

\n\n

Ketentuan substansial dalam peraturan ini mencakup kewajiban bagi industri farmasi dan PBF untuk melaporkan berbagai aspek kegiatan mereka kepada Kepala Badan Pengawas Obat dan Makanan (BPOM). Industri farmasi wajib melaporkan pemasukan dan penggunaan bahan aktif obat, produksi dan distribusi obat serta bahan aktif obat, realisasi ekspor dan impor obat dan bahan obat, serta data industri farmasi. PBF dan PBF Cabang wajib melaporkan pemasukan dan distribusi bahan aktif obat, pemasukan dan distribusi obat, serta realisasi ekspor dan impor obat dan bahan obat.

\n\n

Laporan-laporan ini harus disampaikan secara berkala dengan frekuensi yang bervariasi, mulai dari tiga bulanan, bulanan, mingguan, hingga harian, tergantung pada jenis obat atau bahan aktif obat yang dilaporkan (misalnya, narkotika, psikotropika, prekursor farmasi, obat dengan EUA). Pelaporan dilakukan secara daring melalui laman resmi yang disediakan oleh BPOM. Industri farmasi, PBF, dan PBF Cabang bertanggung jawab atas kebenaran dan keabsahan data yang dilaporkan.

","transitional_provisions","1. Pelaporan sebagaimana dimaksud dalam Pasal 5, untuk obat:\n\n a. golongan obat keras wajib dilaporkan paling lambat 25 Januari 2022; dan\n\n b. golongan obat bebas terbatas dan golongan obat bebas wajib dilaporkan paling lambat 25 Januari 2023.","sanctions","1. Industri Farmasi, PBF dan/atau PBF Cabang yang melanggar ketentuan sebagaimana dimaksud dalam Pasal 2, Pasal 4, Pasal 6, Pasal 7, dan/atau Pasal 9 dikenai sanksi administratif berupa:\n\n a. peringatan;\n\n b. peringatan keras; dan/atau\n\n c. pembekuan izin edar.","revokes",[96],{"_97":98,"_99":100,"_36":101},"text","Peraturan Badan Pengawas Obat dan Makanan Nomor 35 Tahun 2019 tentang Pelaporan Kegiatan Industri Farmasi","link","https://peraturan.go.id/id/peraturan-bpom-no-35-tahun-2019","550f1fe1-90b6-4e62-b8de-9730e3039b31","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.7, 2022

BPOM. Pharmaceutical Industry. Pharmaceutical Wholesaler
Pharmacy. Reporting. Revocation.

REGULATION OF THE FOOD AND DRUG CONTROL AGENCY
NUMBER 2 OF 2022
ON
REPORTING OF PHARMACEUTICAL INDUSTRY ACTIVITIES AND
PHARMACEUTICAL WHOLESALERS

WITH THE BLESSINGS OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG CONTROL AGENCY,

\n\n \n \n

Considering / Whereas:

that the provisions on the implementation of reporting
pharmaceutical industry as stipulated in
Regulation of the Food and Drug Supervisory Agency Number 35
of 2019 on Reporting of Pharmaceutical Industry Activities
is no longer in accordance with legal needs and
the development of science and technology in the field
pharmaceutical industry reporting so it needs to be replaced;
to ensure that circulating drugs meet the standards
and safety, efficacy, and quality requirements,
reporting from the pharmaceutical

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