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
MOPI: Quality Assurance and GMP Training Program 2026 |
Guidance Document Foreign GMP Inspection, 10th Edition |
OBSOLETE_ Good Tissue Practice Guideline |
Pekeliling Berkenaan Pengemaskinian Guidance Document And Guidelines For Registration Of Cell And Gene Therapy Products (CGTPs) In Malaysia (Second Edition) |
Guidance Document: Verification for Traditional Medicines (TM) & Health Supplements (HS) Manufacturers, Second Edition, May 2025 |
Application Forms
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Document Name |
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MS Word |
Updated |
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N3-FR-16/2: Senarai Semak Pra-pemeriksaan |
Nov-24 |
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N3-FR-10/2: Borang Permohonan Sijil Amalan Perkilangan Baik Pengilang Luar Negara |
Nov-24 |
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N3-FR-11/3: Foreign GMP Inspection Application Form |
Nov-24 |
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N3-FR-12/4: Borang Permohonan Penilaian Pelan Susun Atur Premis Pengilang |
Nov-24 |
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N3-FR-14/2: Borang Permohonan Verifikasi Terjemahan Dokumen Rasmi |
Nov-24 |
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Pengumuman Pembayaran Caj Pemeriksaan Secara Pra Bayar |
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Apr-13 |
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N3-FR-15: GMP Desktop Assessment Application Form |
Nov-24 |
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N3-FR-81: Foreign GMP Inspection Corrective Action and Preventive Action (CAPA) Report and Evaluation |
May-25 |
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Document Name |
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MS Word |
Updated |
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N1-FR-04/2: Permohonan Lesen Keluaran Berdaftar (Lesen Pengilang, Lesen Pengimport, Lesen Pemborong) | Application for Licence for Registered Products (Manufacturer's Licence, Import Licence, Wholesaler's Licence) |
Dec-24 |
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N1-FR-05/2: Permohonan Senarai Keluaran (Tambahan) Lesen Keluaran Berdaftar | |
Dec-24 |
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N3-FR-12/4: Borang Permohonan Penilaian Pelan Susun Atur Premis Pengilang |
Nov-24 |
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N3-FR-13/2: Borang Permohonan Pemeriksaan Amalan Perkilangan Baik (APB) |
Nov-24 |