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Revised Application Forms [effective 2 January 2025]

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Dear Applicants,

The BEEC Section has updated the following application forms and manual, effective 2nd January 2025. All applicants are required to use the updated forms for any application processes with the BEEC Section. Please note that applications submitted using previous versions of the forms will be rejected starting 7th February 2025.

  • N3-FR-42 Borang Permohonan Pemeriksaan Pusat Kajian Bioekuivalens Dalam Negara
  • N3-FR-43 Borang Permohonan Pemeriksaan untuk Program Komplians NPRA bagi Pusat Kajian Bioekuivalens (Luar Negara) 
  • N3-FR-46 Borang Permohonan Pendaftaran dan Pemeriksaan Jawatankuasa Etika
  • N3-FR-80 Borang Permohonan Penilaian Penentuan Keperluan Pemeriksaan Kajian Bioekuivalens (BE)
  • N3-FR-51 Borang L1 Maklumat Penilaian Penentuan Keperluan Pemeriksaan Kajian BE
  • N3-FR-52 Manual Permohonan Penilaian Penentuan Keperluan Pemeriksaan Kajian Bioekuivalens
  • N3-FR-56 BEDE Submission Checklist
  • N3-FR-76 Laporan Tahunan Jawatankuasa Etika (new form)

The updated forms can be accessed via the link below:

https://www.npra.gov.my/index.php/en/index.php/application-forms-and-checklist

Your cooperation in adhering to this requirement is greatly appreciated.

Thank you.

 

 

 

National Pharmaceutical Regulatory Agency (NPRA)

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

  • Phone: +603-7883 5400

 

 

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.

Site Last Modified

  • Last Modified: Friday 10 January 2025, 08:50:26.

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