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: Health Supplement

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:

Applicable if CPP is not available, must be issued by the competent authority in the manufacturing country


General/ Functional Claim

a) Malaysia Guidelines on Good Manufacturing Practice for Traditional Medicine and Health Supplement latest edition

OR

b) The accepted standards for GMP will be determined by the category the product is classified in the country of origin.
For example, if the product is classified as food in the country of origin, GMP certificate of food standard issued by relevant country authority will be accepted on condition that the standards are similar to those practices in Malaysia.

OR

c) If the product is not regulated in the country of origin and does not require GMP certification, the manufacturer will have to produce a GMP certificate issued by an independent body recognised by the Authority. Information including the standard/ regulations/ legislation to which the inspection was based upon must be mentioned. 


Disease Risk Reduction Claim

a) Malaysia Guidelines on Good Manufacturing Practice for Traditional Medicine and Health Supplement latest edition 

OR

b) The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) Standards.

OR

c) GMP certificates issued by relevant country authority will be accepted on condition that the standards are similar to PIC/S Standards 

1.4.1.2 Free Sale 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

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

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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