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

Document Name

PDF

MS Word

Updated

NPRA/431/10: Borang Permohonan Sijil Amalan Perkilangan Baik (Sijil APB)

Download

Download

Jun-22

NPRA/431/11-2: Foreign GMP Inspection Application Form

Download

Download

Mar-23

NPRA/431/12-3: Borang Permohonan Penilaian Pelan Susun Atur Premis Pengilang

Download

Download

Mar-23

NPRA/431/14-2: Borang Permohonan Verifikasi Terjemahan Dokumen Rasmi

Download

Download

Mar-23

Pengumuman Pembayaran Caj Pemeriksaan Secara Pra Bayar

Download

-

Apr-13

NPRA/431/15: GMP Desktop Assessment Form

Download

Download

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)

Download

Download

Jun-20

NPRA/414/02: Permohonan Senarai Keluaran (Tambahan) Lesen Keluaran Berdaftar
Application for (Additional) Product List of Licence for Registered Product

Download

Download

Jun-20

NPRA/431/12-3: Borang Permohonan Penilaian Pelan Susun Atur Premis Pengilang

Download

Download

Mar-23

NPRA/431/13: Borang Permohonan Pemeriksaan APB Bukan Rutin

Download

Download

Jun-22

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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