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 Wholesale 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

Document Name PDF MS Word Updated
NPRA/431/10: Borang Permohonan Sijil Amalan Perkilangan Baik (Sijil APB) Jun-22
BPFK 439: Borang Pertukaran Ahli Farmasi Lesen Pengilang / Mengimport / Pemborong Keluaran Berdaftar - Jan-19
NPRA/431/11: Foreign GMP Inspection Application Form Jun-22
NPRA431/12: Borang Permohonan Penilaian Pelan Susun Atur Premis Pengilang Jun-22
NPRA/431/14: Borang Permohonan Verifikasi Terjemahan Dokumen Rasmi Jun-22
Pengumuman Pembayaran Caj Pemeriksaan Secara Pra Bayar - Apr-13
NPRA/431/15: GMP Desktop Assessment Form Jun-22
 
Document Name PDF MS Word Updated
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
NPRA/414/02: Permohonan Senarai Keluaran (Tambahan) Lesen Keluaran Berdaftar
Application for (Additional) Product List of Licence for Registered Product
Jun-20
NPRA/431/12: Borang Permohonan Penilaian Pelan Susun Atur Premis Pengilang Jun-22
NPRA/431/13: Borang Permohonan Pemeriksaan APB Bukan Rutin Jun-22
 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Thursday 30 June 2022, 13:07:58.
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