Step 1 of 4: Pre-submission of Application (Preparation)

1.1. Apply QUEST 3+ Token

To conduct transactions for product registration, variation, licensing, renewal and other related transactions, you must register your membership and purchase your digital certificate in the form of USB token. Once you have obtained and installed your digital certificate, you will be able to conduct your transactions in QUEST 3+.

i. Register USB Token

ii. User Manual for each module

1.2. Product Classification

Before submission of application for a product registration, applicants may submit for product classification if unsure of the product category.

i. Product Classification Guideline

ii. Product Classification Form  : Ms Word  |  PDF 

 

1.3. Payment Mode

Online payment option available for applicants:

i. Payment Using Personal/Current Account - B2C

ii. Payment Using Corporate Account - B2B

ii. Payment Using Credit Card

 

1.4. Product Category:  Natural Product

 

1.4.1 Ensure availability of the following key documents.

 

1.4.1.1 GMP certificate status.

For those companies interested to apply GMP certificate, company can download Borang Permohonan Sijil APB (BPFK-420).

i. Local Manufacturer - GMP certificate status issued by National Pharmaceutical Regulatory Agency (NPRA) as stated in Drug Regulation Guidance Document (DRGD).

ii. Guideline

Good Manufacturing Practice / Good Distribution Practice

Guidance Document Foreign GMP Inspection July 2018

Dokumen Panduan Keperluan Direktif Bilangan 2 Tahun 2014 dan Bilangan 2 Tahun 2015

iii. Note to follow for international manufacturer:

- PIC/S member countries (https://picscheme.org/en/members)

- Non-PIC/S member countries. GMP inspection by National Pharmaceutical Regulatory Agency (NPRA) GMP Inspectors is required.


1.4.1.2 CFS certificate status.

                 Applicable if CPP is not available, must be issued by the competent authority in the country of origin/ products owner country.



1.4.1.3 CPP Certificate in WHO format (For imported product only).

                 Applicable to imported products,  must be issued by the competent authority in the country of origin. CPP issued by reference country  may be   considered.

 

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 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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