Announcement Of Online Appeal Application For Product Rejected By DCA

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  1. We are pleased to announce the implementation of online APPEAL application procedure via QUEST3+ system starting 1st May 2019.
  2. This new procedure is applicable for product registration application originally submitted via QUEST3+ system ONLY.  
  3. For product registration applications submitted via QUEST2/ QUEST3 or manually submitted, kindly send the appeal application manually to the address stated below:

Y.B. Menteri Kesihatan Malaysia
d/a Bahagian Regulatori Farmasi Negara
Kementerian Kesihatan Malaysia
Lot 36, Jalan Universiti
46200 Petaling Jaya, Selangor.
(U.P. Setiausaha PBKD)

4. NPRA will no longer issue formal rejection letter to Product Registration Holder (PRH) for all products (Q3+/Q3/Q2/manual) beginning with the implementation of this online APPEAL application. PRH will receive Notification of the product rejection through email as in the Quest3+ system.

 

* PRH is given 14 days from the date of Notification of the product rejection received through email to submit APPEAL application online.

 

Online APPEAL application instructions

  • Log into QUEST3+, under the ‘submission utilities’ tab on the left panel, select the ‘rejected products’ tab.
  • Then, print out the appeal notice on your company letterhead and send it to the address as stated in point number 3 above.
  • Please submit additional document(s) required to support the appeal application within 60 days through the Quest3+ system.

NOTE:

It is the responsibility of the product registration holder(s) to ensure that company details including email address is accurate and up to date to avoid email delivery failure.

For any enquiries regarding the appeal application, kindly contacts the officer in charge i.e. Ms Wong Hui Ying (03-7883 5528, This email address is being protected from spambots. You need JavaScript enabled to view it.). 

 

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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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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  • Last Modified: Friday 06 December 2019, 11:24:27.
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