3 min read

Quest 3+ Submission System is a consolidated system of Regulatory controls over the pharmaceutical sector in Malaysia, which helps product license holder, manufacturer, importer, re-packer, wholesaler, and other related users for safe online transactions. Few of the transactions can be listed as: registration, variations, re-registration along with limited changes in stored data; which include manufacturing site addresses etc, and other transactions like licensing, and surveillance activities. To conduct such transactions, a user must register his/her membership at utmost priority and buy a USB token consisting of User Digital Certificate. After the installation of the token, the user will be able to conduct transactions in QUEST 3+.

The Quest 3+ System Applicability

This QUEST 3+ submission system is applicable for the below categories

  1. Application / Registration Evaluation of New Products
  2. Application / Product Evaluation of Combos
  3. Application / Additional Rate Indications
  4. Appeal for Product Registration
  5. Application for Certificate of Pharmaceutical Product (CPP)
  6. Application for Change of Holder (COH)
  7. Application for Product Re-Registration
  8. For registration of the products, only the web-based online submissions via QUEST at http://www.bpfk.gov.my shall be accepted.

Pre-requisites for Quest 3+ System

The registration process is completed online inclusive of payments. Listed below are the requirements before performing a transaction with QUEST 3+.

  1. Broadband Internet connection
  2. Google Chrome latest version (recommended) or internet explorer
  3. Valid Digital Certificate (USB Token) – To be purchased online during Membership application
  4. Scanner
  5. PDF Reader/Writer Software
  6. Photo editor to edit (crop, resize or other editing functions) your attachments in jpg format
  7. Valid email account for correspondences and system notifications
  8. Online banking account (Personal or Business) or credit card to conduct payment transactions via FPX (Financial Process Exchange). FPX is a payment channel that allows you to make payment via online real-time through your current or savings account.

Methodology and Processing Time for Quest 3+

Quest 3+ includes online transactions/submission of the documents for product registration, variation, licensing, renewal, and other related transactions. The evaluation period normally takes 3 business days, and the USB token is generally issued within 7 business days.

Similar Programmes

The Quest 3+ is the updated version of Quest 2/3, which are not in use at present.

Common Problems Applicants May Face During Quest 3+ Submission

  1. How to write a company authorization letter?
  2. How to print a payment voucher?
  3. Can a company have more than one token?
  4. How to install a USB token into my computer?

Membership Registration - Process Flow

Whether supplementary user membership or new membership registration, one must follow below mentioned initial steps-

  1. Log on to National Pharmaceutical Control Bureau (NPCB) website.
  2. Click on "Proceed" button to register your membership. Please take note that the membership registration form requires you to attach scanned images/picture (in JPEG or PDF format, with size below 2MB) as follows:
  • Your Company Registration Form with the Malaysian R.O.C.
  • Company Authorization Letter (Official letter of authorization by your company for you to conduct the transaction on behalf of the company)
  • Your MyKad / Passport (front & back)

New Membership Registration in Quest3+.

  1. Register on https://quest3plus.bpfk.gov.my
  2. Click on the register (New User) to proceed with the membership registration form
  3. Fill the form and upload the attachments with-
  4. Copy of IC authorized person/passport if foreigner
  5. Letter of authorization
  6. Company registration certificate from SSM (Form 9 & MAA is required for Berhad/Sdn BHD only)
  7. Submit the application online
  8. You will receive an email notification with the link to check membership status online
  9. Evaluation by NPRA within 3 working days
  10. 7.Either rejection or approval will be granted, if rejected the process must restart as explained in the flow chart.
  11. If approved, fill the online form at www.msctrustgate.com and click on apply at Quest3plus menu box to proceed with payment
  12. Once the USB token is received, install it as per the user manual
  13. Login and proceed for product registration and cosmetic notification

Supplementary User Registration in Quest 3 +.

  1. Login to Quest 3+
  2. Click on membership utility menu and select “add supplementary user.”
  3. Fill the form and upload the attachments with-
  • Copy of IC authorized person/passport if foreigner
  • Letter of authorization
  1. Submit the application online
  2. You will receive an email notification with the link to check membership status online
  3. Evaluation by the NPRA within 3 working days
  4. Either rejection or approval will be granted. If rejected, the process must restart as explained in the flow chart.
  5. If approved, fill the online form at www.msctrustgate.com and click on apply at Quest 3+ menu box to proceed with payment
  6. Once the USB token is received, install it as per the user manual

Login and proceed for product registration and cosmetic notification