Regulatory Information

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.

Guidelines Directives CircularsCompliance StatusGMP Inspection DataGDP Inspection Data FAQs (Licensing / GMP / GDP)

Recent Updates, Directives & Circulars

  • Recent Updates for Guidelines, Circulars, Directives, FAQ & Announcements for Licensing and Inspection
  • Directives & Circulars Related to Licensing and Inspection
  • Recent Updates
  • Directives
  • Circulars

Update Of 'Borang Permohonan Sijil Indikasi / Sijil Deklarasi Bagi Produk Berdaftar Dengan Pihak Berkuasa Kawalan Dadah'
published on 2026-04-20

MOPI: Quality Assurance and GMP Training Program 2026
published on 2025-12-19

Guidance Document Foreign GMP Inspection, 10th Edition
published on 2025-12-02

OBSOLETE_ Good Tissue Practice Guideline
published on 2025-10-10

Pekeliling Berkenaan Pengemaskinian Guidance Document And Guidelines For Registration Of Cell And Gene Therapy Products (CGTPs) In Malaysia (Second Edition)
published on 2025-09-22

04Mar

Arahan Pengarah Kanan Perhidmatan Farmasi Bilangan 1 Tahun 2012 - Larangan Aktiviti Pengilangan Produk Makanan Minuman Dalam Premis Pengilangan Tradisional Berlesen

14Nov

Pekeliling bagi Direktif Mengenai Syarat Pendaftaran Produk Farmaseutikal dari Luar Negara Berkaitan Keperluan APB

14Nov

Pekeliling untuk Memaklumkan Pengilang Kosmetik Tempatan Berkenaan Keperluan Pematuhan kepada Amalan Perkilangan Baik (APB) Sebelum Mengemukakan Notifikasi Kosmetik (23 Mac 2016)

14Nov

Caj Baru Pemeriksaan Amalan Perkilangan Baik (APB) bagi Premis Tempatan dan Luar Negara

See all directives14Nov

Pekeliling bagi Direktif Mengenai Syarat Pendaftaran Produk Farmaseutikal dari Luar Negara Berkaitan Keperluan APB

14Nov

Pekeliling untuk Memaklumkan Pengilang Kosmetik Tempatan Berkenaan Keperluan Pematuhan kepada Amalan Perkilangan Baik (APB) Sebelum Mengemukakan Notifikasi Kosmetik (23 Mac 2016)

14Nov

Caj Baru Pemeriksaan Amalan Perkilangan Baik (APB) bagi Premis Tempatan dan Luar Negara

14Nov

Pekeliling pemeriksaan Amalan Pengilangan Baik (APB) Bagi Pengilang di Luar Negara (Bil (35) dlm. BPFK/PPP/01/03)

See all circulars

Application Forms

  • Compliance and Licensing Forms
  • Application Forms for Government Agencies

Document Name

PDF

MS Word

Updated

N3-FR-16/2: Senarai Semak Pra-pemeriksaan

Download

Download

Nov-24

N3-FR-10/2: Borang Permohonan Sijil Amalan Perkilangan Baik Pengilang Luar Negara

Download

Download

Nov-24

N3-FR-11/3: Foreign GMP Inspection Application Form

Download

Download

Nov-24

N3-FR-12/4: Borang Permohonan Penilaian Pelan Susun Atur Premis Pengilang

Download

Download

Nov-24

N3-FR-14/2: Borang Permohonan Verifikasi Terjemahan Dokumen Rasmi

Download

Download

Nov-24

Pengumuman Pembayaran Caj Pemeriksaan Secara Pra Bayar

Download

-

Apr-13

N3-FR-15: GMP Desktop Assessment Application Form

Download

Download

Nov-24

N3-FR-81: Foreign GMP Inspection Corrective Action and Preventive Action (CAPA) Report and Evaluation

Download

Download

May-25

Document Name

PDF

MS Word

Updated

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)

Download

Download

Dec-24

N1-FR-05/2: Permohonan Senarai Keluaran (Tambahan) Lesen Keluaran Berdaftar |
Application for (Additional) Product List of Licence for Registered Product

Download

Download

Dec-24

N3-FR-12/4: Borang Permohonan Penilaian Pelan Susun Atur Premis Pengilang

Download

Download

Nov-24

N3-FR-13/2: Borang Permohonan Pemeriksaan Amalan Perkilangan Baik (APB)

Download

Download

Nov-24