Vaccine Lot Release

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Vaccine Lot Release

Guidelines

Document Name	Updated
Guidance Document for Vaccine Lot Release in Malaysia 3rd edition 1 Dec 2016	Dec-2016
Slides Pembentangan Taklimat VLR 23 Disember 2014	Dec-2014
Slaid Pembentangan Taklimat Yuran 23 Nov 2015	Nov-2015
Panduan Bayaran Yuran Vaccine Lot Release	Nov-2015
Guidance Document for Biological Lot Release (effective 1st January 2020)	13-Nov 2019
Slide-1 Pembentangan Taklimat Extension of Lot Release Activities 12 Nov 2019	13-Nov 2019
Slide-2 Pembentangan Taklimat Extension of Lot Release Activities 12 Nov 2019	13-Nov 2019

Application Forms

Document Name	PDF	MS Word	Updated
Application Form Vaccine Lot Release version 3			Nov-2016
Lot Release Application form (New)			Nov-2019
Sampel Submission Application Form (New)			Nov-2019

LOT RELEASE CERTIFICATE

NOTIFICATION OF NON-COMPLIANCE

Recent Updates

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

Direktif Pelaksanaan Vaccine Lot Release ke atas Semua Produk Vaksin Berdaftar di Malaysia
published on 2015-01-14

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: Thursday 15 April 2021, 16:41:44.