Compliance and Licensing
Compliance and Licensing
According to the Controls of Drugs and Cosmetics Regulations 1984, any company that want to manufacture, import or wholesale any registered products need to have Manufacturer’s License, Import License or Wholesaler's License.
Recent Updates, Directives & Circulars
- Recent Updates for Guidelines, Circulars, Directives, FAQ & Announcements for Licensing and Inspection
- Directives & Circulars Related to Licensing and Inspection
Application Forms
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Document Name |
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MS Word |
Updated |
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NPRA/431/16-3: Senarai Semak Pra-pemeriksaan |
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May-24 |
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NPRA/431/10-2: Borang Permohonan Sijil Amalan Perkilangan Baik (Sijil APB) |
Aug-24 |
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NPRA/431/11-3: Foreign GMP Inspection Application Form |
Aug-24 |
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NPRA/431/12-4: Borang Permohonan Penilaian Pelan Susun Atur Premis Pengilang |
Aug-24 |
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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/431/12-4: Borang Permohonan Penilaian Pelan Susun Atur Premis Pengilang |
Aug-24 |
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NPRA/431/13-2: Borang Permohonan Pemeriksaan APB Bukan Rutin |
Aug-24 |
