[{"_1":2,"_125":-5,"_126":-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","f78f6553-974e-4fff-86d5-8f44967b9def","regulationData",{"_36":33,"_37":38,"_121":122,"_123":124},"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,"_69":70,"_71":72,"_73":74,"_75":76,"_77":-5,"_78":79,"_80":81,"_82":-5,"_83":84,"_85":86,"_87":86,"_88":89,"_90":91,"_92":93,"_94":95,"_96":97,"_104":105,"_110":111,"_112":113,"_114":115,"_116":117,"_118":-5,"_119":120},"title","Peraturan Badan Pengawas Obat dan Makanan Nomor 13 Tahun 2021 tentang Perubahan Ketiga atas Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 24 Tahun 2017 tentang Kriteria dan Tata Laksana Registrasi Obat","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 13 Tahun 2021","number","13","year","2021","published_date","2021-04-28","effective_date","2021-04-29","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",[],"tags",[],"location","Badan Pengawas Obat dan Makanan","place_of_enactment","Jakarta","theme","Perubahan Ketiga atas Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 24 Tahun 2017 tentang Kriteria dan Tata Laksana Registrasi Obat","subject_matter","abstract","\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n


2021
Peraturan Badan Pengawas Obat dan Makanan NO. 13, BN.2021/No. 461, peraturan.go.id : 11 hlm.
Peraturan Badan Pengawas Obat dan Makanan TENTANG Perubahan Ketiga atas Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 24 Tahun 2017 tentang Kriteria dan Tata Laksana Registrasi Obat
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 29 April 2021. \n \n

","regulatory_relationship","Peraturan ini mengubah:\n1. Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 24 Tahun 2017 tentang Kriteria dan Tata Laksana Registrasi Obat, sebagaimana telah diubah terakhir dengan Peraturan Badan Pengawas Obat dan Makanan Nomor 27 Tahun 2020.","scope_and_parties","policy_content","

Latar Belakang dan Tujuan: Peraturan ini bertujuan untuk menyesuaikan ketentuan mengenai persetujuan penggunaan darurat (EUA) dengan kriteria dan persyaratan keamanan, khasiat, dan mutu. Hal ini dilakukan untuk memastikan bahwa obat yang digunakan dalam kondisi darurat kesehatan masyarakat memenuhi standar yang diperlukan.

Ketentuan Substansial: Peraturan ini mengatur prosedur registrasi obat, termasuk definisi dan kriteria untuk berbagai jenis obat seperti obat generik, obat biologi, dan obat impor. Perubahan utama mencakup penyesuaian ketentuan mengenai EUA, yang memungkinkan izin edar sementara selama kondisi darurat kesehatan. Pendaftar harus melakukan registrasi untuk mendapatkan EUA, dan obat harus memenuhi kriteria tertentu seperti bukti ilmiah yang cukup dan analisis manfaat-risiko. Industri farmasi yang memiliki EUA bertanggung jawab atas mutu obat dan harus melakukan studi lanjutan serta pelaporan efek samping.

","transitional_provisions","(-)","sanctions","revokes",[],"revoked_by",[],"partially_revokes",[],"partially_revoked_by",[],"amends",[98],{"_99":100,"_101":102,"_36":103},"text","Perka BPOM No. 24 Tahun 2017 tentang Kriteria dan Tata Laksana Registrasi Obat","link","https://peraturan.bpk.go.id/Details/220387/perka-bpom-no-24-tahun-2017","28c5213f-981b-4796-b92d-469e55048fa5","amended_by",[106],{"_99":107,"_101":108,"_36":109},"Peraturan BPOM No. 15 Tahun 2023 tentang Perubahan Keempat Atas Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 24 Tahun 2017 tentang Kriteria dan Tata Laksana Registrasi Obat","https://peraturan.bpk.go.id/Details/263266/peraturan-bpom-no-15-tahun-2023","bf877323-c92b-47da-99df-38681843a13b","partially_amends",[],"partially_amended_by",[],"establishes",[],"established_by",[],"constitutional_review","is_verified",false,"english_excerpt","\n

STATE GAZETTE
REPUBLIC OF INDONESIA

No. 461, 2021

BPOM. Drug Registration. Criteria. Procedures. Changes.

REGULATION OF THE FOOD AND DRUG CONTROL AGENCY
NUMBER 13 OF 2021

ABOUT

THIRD AMENDMENT TO THE REGULATION OF THE HEAD OF THE FOOD AND DRUG CONTROL AGENCY
NUMBER 24 OF 2017 CONCERNING CRITERIA AND PROCEDURES
FOR DRUG REGISTRATION

BY THE GRACE OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG CONTROL AGENCY,

\n","pdf_url","/proxy/pdf?id=f78f6553-974e-4fff-86d5-8f44967b9def","actionData","errors"]