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Regulasi Ijin Edar Bpom

Regulasi Ijin Edar Bpom

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Published by Dewa Dewanto
ijin
ijin

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Categories:Types, School Work
Published by: Dewa Dewanto on May 27, 2013
Copyright:Attribution Non-commercial

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02/07/2014

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1
Oleh :
Dra Isna’ Assaratun MSc, Apt
 
REGULASI IZIN EDAROBAT TRADISIONAL
Disampaikan padaAcara Pertemuan DinkesPropinsi Jawa Timur2006
 
2
1.
OT hanya dapat diedarkansetelah mendapat izin edar 
2.
Melindungi masyarakat terhadapOT yang dapat mengganggu danmerugikan kesehatan (aman,bermutu dan bermanfaat )
3.
Memberikan iklim yang baikbagi pengembangan usaha OT
 
LATAR BELAKANG
DASAR HUKUM ?
 
3
IZIN USAHA IKOT KE KANWILPERSETUJUAN PENDAFTARANKE DIRJEN
PELIMPAHAN WEWENANGPERMENKES No 2461990 ( psl 5 )
DASAR HUKUM
UU RI No 23 TH 1992 ttgKESEHATAN ( psl 41 ay 1 )
PP RI No 72 TH 1998 ttgPENGAMANAN SEDIAANFARMASI DAN ALKES ( psl 9 ay 1)
PP 17 / 2001 tentang Tarif AtasPenerapan Penerimaan NegaraBukan Pajak yang berlaku diBadan POM
Kep Ka Badan POMNo.HK.00.05.4.1384 th.2005tentang Kriteria dan Tata LaksanaPendaftaran OT
 
Pengganti UU Pokok-pokokKesehatan No 9 1960

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