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Announcements, product safety communications and regulatory updates.
2018 Education Seminar Series: Analysis of Findings from GMP Inspections of Pharmaceutical Manufacturers & Introduction to ‘Guidance Document of Pre-Approval GMP Inspection 17 October 2018…
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NRC 2018 – Post Conference Seminar 2018 : WHO Good Practices for Desk Assessment for Compliance with GMP/GCP/GLP Date: 4 October 2018 (2.00 pm – 5.15 pm) Venue: Suria on 12, Hotel Royale Chulan…
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Latihan TMHS – Product Quality Review (PQR) Dan Verifikasi Date: 21 - 22 November 2018 (Rabu dan Khamis) Venue: Royale Chulan Damansara, Petaling Jaya MASA: 8.30 pagi – 5.00 petang OBJEKTIF LATIHAN…
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Document Name PDF MS Word Updated Template for Declaration of Worldwide Registration Status (WWRS) E15 - Download 3/2023 Borang Permohonan Sijil Indikasi / Sijil Deklarasi Download Download 4/2026…
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Kindly take note that BE study reports for re-registration purposes should ONLY be submitted to NPRA within six (6) to twelve (12) months prior to the expiry of the validity period of the product…
Direktif BPFK/PPP/01/03/J3(11) bertarikh 27 Jun 2014 adalah dirujuk. Garispanduan untuk prosedur kawalan regulatori API boleh didapati di Guidance Notes Required Documents for API Information Version…
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Overview Acetazolamide is a sulfonamide derivative, which functions as a carbonic anhydrase inhibitor1. It acts on the renal tubules to increase excretion of bicarbonate, sodium, and potassium…
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Sejak kebelakangan ini, Bahagian Regulatori Farmasi Negara (NPRA) telah menerima laporan berkaitan kes penipuan atau scam menggunakan panggilan telefon. Didapati bahawa terdapat pelanggan NPRA yang…
Dear product registration holder (PRH) / QUEST3+ user, NPRA seeks your kind cooperation to check addresses registered under your company in order to ensure there is no duplicated address or inactive…
It is important for the applicant to prepare and submit application with good quality dossier in order to obtain early approval in the registration process. The Good Submission Practice shall enhance…
Sila maklum bahawa Yuran Pemprosesan Permohonan Variasi Produk akan mula dikenakan pada 1 April 2017. Sila rujuk pekeliling dengan nombor rujukan (40)dlm.BPFK/PPP/01/03Jld.3 bertarikh 31 Disember…
Assalamualaikum & Selamat Sejahtera, Kepada Pengguna Sistem QUEST3, Sistem QUEST3 akan ditutup bermula 15 September 2017. Untuk pengguna yang masih menjalankan proses correspondense dinasihatkan…
1. Applicant to submit dossier/application and payment of new FEO products manually to finance department. 2. Finance department will issue receipt & submit documents to PPP. 3. Evaluation and…
Export button use Adobe Flash plugin. If you do not have adobe plugin installed or the plugin outdated, please install or update first 1. Log In into QUEST3+ system using token. Enter the page that…
Dear QUEST3+ User, Variation will be opened for Section E13 & Section S beginning 22 November 2017. In order to apply for variations regarding to Field E13 and Section S in QUEST3+, the products must…
Dear QUEST3+ User, For products that Registration process done Manually and migrated into QUEST3+, Data cleaning will be opened for submission from 13 - 24 November 2017. Submission can be made via…
Seperti yang Tuan/Puan sedia maklum, permohonan pendaftaran semula produk perlu dikemukakan dalam tempoh 6 bulan sebelum tamat tempoh pendaftaran. Pada kebiasaannya, surat peringatan akan dikeluarkan…
Modul FEO secara atas talian akan dibuka pada 8 Jan 2018 (Isnin) melalui sistem Q3+. Sebarang permohonan FEO secara offline tidak akan diterima lagi selepas tarikh ini.
Quest 3 + (E.13 Submission for Data Cleaning) For the purpose of data cleaning and E.13 update on approved product Applicant should submit the documents by separating the documents based on test…
PERINGATAN: Tarikh perlaksanaan kawalan regulatori API untuk permohonan baru produk generik yang mengandungi Racun Berjadual bagi produk dalam SEMUA bentuk dos berkuatkuasa 1 JULAI 2018. Download…
Salam sejahtera & 1 Malaysia, Y.Bhg.Datuk/Dato'/Datin/Dr./Tuan/Puan, Kepada syarikat pemegang produk yang berminat dan bersedia untuk melakukan data cleaning bagi Section S dan field E13 (bagi semua…
Dear QUEST3+ Users, We have upgraded our security facilities to protect QUEST3+ system against zero-day exploits, impersonation and known vulnerabilities and attackers. Some features might not…
