[{"_1":2,"_131":-5,"_132":-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","b3f874b5-3a57-4009-9b78-4eddd1bc8352","regulationData",{"_36":33,"_37":38,"_127":128,"_129":130},"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,"_75":76,"_77":78,"_79":80,"_81":82,"_83":-5,"_84":85,"_86":87,"_88":-5,"_89":90,"_91":92,"_93":92,"_94":95,"_96":97,"_98":99,"_100":101,"_102":103,"_110":111,"_116":117,"_118":119,"_120":121,"_122":123,"_124":-5,"_125":126},"title","Peraturan Menteri Kesehatan Nomor 16 Tahun 2013 tentang Perubahan atas Peraturan Menteri Kesehatan Nomor 1799/MENKES/PER/XII/2010 tentang Industri Farmasi","short_title","Peraturan Menteri Kesehatan Nomor 16 Tahun 2013","number","16","year","2013","published_date","2013-02-22","effective_date","2013-01-01","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","f56450e8-0878-4624-b859-3ca52b69d8e6","type",{"_55":61,"_56":64,"_65":66},"Peraturan Menteri Kesehatan","short_name","Permenkes","subjects",[69,72],{"_55":70,"_56":71,"_58":-5},"10e70ff8-158d-4e9e-849e-554938c706d9","Pelayanan Kesehatan",{"_55":73,"_56":74,"_58":-5},"54d08c24-6ebe-45ac-aceb-ef774a10c175","Badan Usaha & Perdagangan","tags",[],"location","Kementerian Kesehatan","place_of_enactment","Jakarta","theme","Perubahan atas Peraturan Menteri Kesehatan Nomor 1799/MENKES/PER/XII/2010 tentang Industri 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


2013
Peraturan Menteri Kesehatan NO. 16, BN.2013/NO.442/ peraturan.go.id : 6 Hlm.
Peraturan Menteri Kesehatan TENTANG Perubahan atas Peraturan Menteri Kesehatan Nomor 1799/MENKES/PER/XII/2010 tentang Industri Farmasi
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Menteri Kesehatan ini mulai berlaku pada tanggal 01 Januari 2013. \n \n

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Latar Belakang dan Tujuan

Peraturan ini dibuat untuk menjamin keamanan, khasiat, dan mutu obat serta ketersediaannya bagi masyarakat. Tujuannya adalah memberikan landasan hukum yang memacu percepatan pembaharuan izin industri farmasi sesuai ketentuan yang berlaku, mengingat masih banyak industri farmasi yang belum melakukan pembaharuan izin sesuai peraturan sebelumnya.

Ketentuan Substansial

Peraturan ini mengatur pembaharuan izin industri farmasi dengan persyaratan yang meliputi dokumen administratif seperti surat permohonan, sertifikat CPOB, daftar kapasitas produksi, dan lain-lain. Proses pembaharuan izin harus diselesaikan dalam waktu 14 hari kerja setelah dokumen dinyatakan lengkap. Kewajiban ini berlaku bagi semua industri farmasi yang ingin memperbarui izin operasionalnya.

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STATE GAZETTE
REPUBLIC OF INDONESIA

No.442, 2013

MINISTRY OF HEALTH. Pharmaceutical Industry.
Licensing. Implementation. Changes.

REGULATION OF THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA
NUMBER 16 OF 2013
ABOUT
AMENDMENT TO THE REGULATION OF THE MINISTER OF HEALTH
NUMBER 1799/MENKES/PER/XII/2010 CONCERNING THE PHARMACEUTICAL INDUSTRY

BY THE GRACE OF GOD ALMIGHTY

MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA

\n\n \n \n

Considering:

that in order to ensure the safety, efficacy/benefits, and quality of drugs and/or medicinal ingredients and their availability to the public, it is necessary to provide a legal basis that encourages the acceleration of pharmaceutical industry license renewals in accordance with applicable regulations;
that many pharmaceutical industries have not yet renewed their licenses in accordance with Regulation of the Minister of Health Number

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