Vaccine Lot Release

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Vaccine Lot Release

Guidelines

Document Name	Updated
Guidance Document for Biological Lot Release (effective 1st January 2020)	13-Nov 2019
Guidance Document for Lot Release of Biological Products Manufactured in Malaysia	Apr-2021

Application Forms

Document Name	PDF	MS Word	Updated
Lot Release Application form for Imported Products			Dec-2019
Sampel Submission Application Form for Imported Products			Dec-2019
Vaccine/Plasma Product Arrival Report for Cold Chain Inspection			Apr-2021
Lot Release Application Form for Biological Products Manufactured in Malaysia			Apr-2021
Sample Submission Form for Biological Products Manufactured in Malaysia			Apr-2021

Directives

Document Name	Updated
Direktif berkenaan pelaksanaan aktiviti Lot Release ke atas produk vaksin dan produk plasma yang dikilangkan di Malaysia	Apr-2021
Direktif Keperluan Ujian Fizikal untuk Lot Release - Tahun 2020	May -2021
Direktif Pelaksanaan Plasma Products Lot Release - Tahun 2016	May-2021
Direktif Pelaksanaan Vaccine Lot Release - Tahun 2015	May-2021

LOT RELEASE CERTIFICATE

NOTIFICATION OF NON-COMPLIANCE

Recent Updates

Direktif berkenaan pelaksanaan aktiviti Lot Release ke atas produk vaksin dan produk plasma yang dikilangkan di Malaysia
published on 2021-04-28

Keputusan Pihak Berkuasa Kawalan Dadah (PBKD) Berkenaan Pengecualian Daripada Keperluan Menjalankan Ujian Fizikal Untuk Aktiviti Lot Release Bagi Semua Produk Vaksin COVID-19 Berdaftar Yang Diimport dan Digunakan Semasa Situasi Pandemik
published on 2021-02-19

Direktif keperluan menjalankan ujian fizikal untuk aktiviti Lot Release bagi semua vaksin dan produk plasma berdaftar
published on 2020-05-15

Cold Chain Inspection
published on 2018-09-25

Guideline on Good Distribution Practice (Third Edition, 2018)
published on 2018-01-01

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

Email: npra@npra.gov.my
Phone: +603-7883 5400
Fax: +603-7956 2924, +603-7956 7075

More Links

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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Site Last Modified

Last Modified: Friday 15 October 2021, 15:58:04.