Page 7 - Pedoman Pelayanan Publik Izin Edar Alkes dan PKRT selama Pandemi Covid 19
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DAFTAR ISI
KATA PENGANTAR ........................................................................ i
DAFTAR ISI ................................................................................... vi
DAFTAR GAMBAR ...................................................................... viii
DAFTAR TABEL ............................................................................ ix
RINGKASAN EKSEKUTIF .............................................................. x
BAB I .............................................................................................. 1
PENDAHULUAN ............................................................................. 1
1.1 Latar Belakang ..................................................................... 1
1.2 Landasan Hukum ................................................................. 2
1.3 Tujuan ................................................................................... 4
1.4 Sasaran ................................................................................. 4
1.5 Ruang Lingkup ..................................................................... 4
BAB II
LAYANAN IZIN EDAR ALKES, ALKES DIV DAN PKRT UNTUK
PENANGANAN COVID-19 DALAM KONDISI PANDEMI ............. 6
2.1 Ketentuan Umum ................................................................. 6
2.2 Alur Pelayanan dan Janji Layanan ...................................10
2.2.1 Tata cara permohonan izin edar Alkes, Alkes DIV
serta PKRT secara umum ........................................11
2.2.2 Tahapan pendaftaran izin edar baru Alkes, Alkes DIV
dan PKRT ...................................................................12
2.3 Tarif PNBP ...........................................................................13
2.4 Persyaratan Izin Edar .........................................................14
2.3.1 Izin Edar Alkes dan Alkes DIV ...................................14
2.3.2 Persyaratan izin edar PKRT ......................................28
BAB III
PENGAJUAN REKOMENDASI UNTUK IMPOR ALKES (SAS)
DAN PKRT TANPA IZIN EDAR ....................................................42
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