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
BPFK 420: Permohonan Sijil Amalan Perkilangan Baik (Sijil APB) Jul-18
BPFK 439: Borang Pertukaran Ahli Farmasi Lesen Pengilang / Mengimport / Pemborong Keluaran Berdaftar - Jan-19
BPFK 501: Foreign GMP Inspection Application Form Mar-21
BPFK 503: Borang Permohonan Penilaian Pelan Susun Atur Premis Pengilang Jul-21
BPFK 505: Borang Permohonan Verifikasi Terjemahan Dokumen Rasmi May-20
Pengumuman Pembayaran Caj Pemeriksaan Secara Pra Bayar - Apr-13
 
Document Name PDF MS Word Updated
NPRA-413: 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-413T: Permohonan Senarai Keluaran (Tambahan) Lesen Keluaran Berdaftar
Application for (Additional) Product List of Licence for Registered Product		 Jun-20
BPFK 503: Borang Permohonan Penilaian Pelan Susun Atur Premis Pengilang Mar-20
BPFK 504: Borang Permohonan Pemeriksaan APB Bukan Rutin - Jul-21
 

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

DISCLAIMER

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 29 July 2021, 11:40:58.
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