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Guidance documents, forms, circulars and reports issued by the Authority.
Document Name Updated Direktif untuk Pelaksanaan Plasma Products Lot Release ke atas Semua Produk Plasma yang Berdaftar di Malaysia 29-Jun-16
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Document Name Download Updated Direktif Pelaksanaan Vaccine Lot Release ke atas Semua Produk Vaksin Berdaftar di Malaysia DOWNLOAD 14 Jan 2015 Direktif Pelaksanaan VLR.pdf
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Document Name Download Updated Keperluan Penetapan Had Lovastatin dari Sumber Asli dalam Produk Semulajadi DOWNLOAD 27 July 2011
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Document Name Download Updated Direktif Pelaksanaan Penukaran Had Ujian Keseragaman Berat Bagi Produk Semulajadi Dan Suplemen Kesihatan Daripada Had BPFK 1995 Kepada Had USP Terkini DOWNLOAD 27 July…
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Document Name Download Updated Penambahan Ujian Kadmium (Cd) Dalam Pengujian Logam Toksik Untuk Produk Tradisional DOWNLOAD 12 Agust 2004
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Document Name Download Updated Larangan Penggunaan Bahan 'Premix' dalam Formulasi Produk Semulajadi (Tradisional) DOWNLOAD 26 Mei 2009
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Document Name Download Updated KEPERLUAN PELABELAN PRODUK: Penambahan Nama dan Alamat Pemegang Pendaftaran Pada Label Produk Tradisional (Semuajadi) dan Suplemen Kesihatan DOWNLOAD 26 Mei 2009
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Document Name Download Updated Keperluan Pendaftaran Produk Foot Patch di bawah Unit Produk Semulajadi (Tradisional) DOWNLOAD 21 Feb 2013
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Document Name Download Updated Notis Pemberitahuan Kuantiti Sampel Tradisional Bagi Tujuan Pengujian Makmal DOWNLOAD 21 Feb 2013
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Document Name Download Updated Pelaksanaan Keperluan Sistem Air Terawat dan Pengudaraan Berpusat di Premis Pengilang Tradisional DOWNLOAD 21 Feb 2013
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Document Name Download Updated Tempoh Hayat Simpanan (Shelf-Life) Bagi Produk Tradisional Dan Supplemen Kesihatan. DOWNLOAD 27 Nov 2014 SHELF LIFE TMHS.pdf
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Document Name Download Updated Keperluan Pengasingan Premis Pengilangan Produk Tradisional dan Suplemen Kesihatan dengan Kosmetik terkini.pdf DOWNLOAD 10 Dec 2014 Keperluan Pengasingan Premis…
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Document Name Download Updated Pekeliling Pemansuhan Sistem Rayuan Pengujian Sampel (Appeal for Sample Retesting) bagi Sampel Pendaftaran Produk Tradisional yang Tidak Lulus Pengujian Makmal Kali…
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Regulatory Control of API for Registered Products This section is applicable for registered products containing Scheduled Poison with the expiration of the registration period starting 1 January…
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Document Name Download Updated Declaration Letter for an Approved API in New Product Registration Application DOWNLOAD Dec-19 Declaration on GMP of API Intermediate DOWNLOAD Aug-18 Declaration on…
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Latest Announcement 17 June 2020 A temporary notice on mode of DMF submission by DMF Holders are as below: NPRA understands the impact of COVID-19 pandemic on regulatory affairs, many countries are…
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Document Name Download Updated DRGD - Appendix 11 : Regulatory Control Of Active Pharmaceutical Ingredients (APIs) DOWNLOAD Jan-2024 Guidance Notes for API Information for Product Registration…
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Document Name Download Updated Application form for Private Laboratory Recognition by NPRA for Traditional Products Testing DOWNLOAD 19 Oktober 2020
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Document Name Download Updated Guideline for Application of Private Laboratories Complying to NPRA Requirements for Traditional Products Testing DOWNLOAD Sept-2021 Guideline for Application of…
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Document Name Download Updated List of GLP Compliant Test Facilities DOWNLOAD Mar. 2026
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Document Name Updated Malaysian Guideline for National Pharmaceutical Regulatory Agency (NPRA) Good Laboratory Practice (GLP) Compliance Programme 1st Edition 15 May 2026 OECD Series on Principles of…
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Document Name PDF MS Word Updated N3-PK-01 - Pengendalian Permohonan Pensijilan Amalan Makmal Baik (GLP) Download - Jan 2026 N3-FR-30/5 - Borang Permohonan Pemeriksaan untuk Program Komplians Amalan…
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Document Name Updated Direktif Untuk Penggunaan Malaysian Guideline for National Pharmaceutical Regulatory Agency (NPRA) Good Laboratory Practice (GLP) Compliance Programme 1st Edition 15 May 2026…
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Document PDF MS Word Updated Checklist for submission of section P9 (Quest 3+ system) Application For Biopharmaceutics Classification System (BCS) Biowaiver Download Download Aug-2024 Application For…
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Download Directive in PDF
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