Compliance and Licensing
Compliance and Licensing
Recent Updates, Directives & Circulars
- Recent Updates for Guidelines, Circulars, Directives, FAQ & Announcements for Licensing and Inspection
- Directives & Circulars Related to Licensing and Inspection
An Analysis of Deficiencies Observed During On-Site Good Manufacturing Practice (GMP) Inspections of Local and Foreign Manufacturing Premise of Medicinal Registered Products in the Year 2022 |
Change of Venue for the National Regulatory Conference (NRC) 2023 to M Resort & Hotel, Kuala Lumpur |
Publication of Revised PIC/S Annex 1 |
Perlaksanaan Pemeriksaan Regulatori Dalam dan Luar Negara Secara Lapangan ('On-Site') oleh Bahagian Regulatori Farmasi Negara (NPRA) |
Cold Chain Facilities List |
Application Forms
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Document Name |
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MS Word |
Updated |
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NPRA/431/10: Borang Permohonan Sijil Amalan Perkilangan Baik (Sijil APB) |
Jun-22 |
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NPRA/431/11-2: Foreign GMP Inspection Application Form |
Mar-23 |
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NPRA/431/12-3: Borang Permohonan Penilaian Pelan Susun Atur Premis Pengilang |
Mar-23 |
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NPRA/431/14-2: Borang Permohonan Verifikasi Terjemahan Dokumen Rasmi |
Mar-23 |
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Pengumuman Pembayaran Caj Pemeriksaan Secara Pra Bayar |
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Apr-13 |
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NPRA/431/15: GMP Desktop Assessment Form |
Jun-22 |
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Document Name |
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MS Word |
Updated |
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NPRA/414/01: Permohonan Lesen Keluaran Berdaftar (Lesen Pengilang, Lesen Pengimport, Lesen Pemborong) Application for Licence for Registered Products (Manufacturer's Licence, Import Licence, Wholesaler's Licence) |
Jun-20 |
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NPRA/414/02: Permohonan Senarai Keluaran (Tambahan) Lesen Keluaran Berdaftar |
Jun-20 |
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NPRA/431/12-3: Borang Permohonan Penilaian Pelan Susun Atur Premis Pengilang |
Mar-23 |
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NPRA/431/13: Borang Permohonan Pemeriksaan APB Bukan Rutin |
Jun-22 |
