Step 3 : Screening

Star InactiveStar InactiveStar InactiveStar InactiveStar Inactive
 

1.  Screening evaluation will be performed at evaluator’s end. Timeline: 30 working days

After an online submission of the product registration application has been done, the application shall be undergone an initial evaluation (or known as screening process) which shall ensure the required data/ information of the submitted application are complete. Further evaluation shall be done after payment for the application has been made. Screening is performed by 3 departments: Generic, API, Lab.

 

2. Outcome of screening evaluation: -

  • SATISFACTORY    -  Only a complete application shall be accepted and approved for payment. Upon screening approval, the applicant is requested to proceed for payment and submission of hard copy documents (if applicable). The applicant is advised to keep a copy of the payment voucher as reference. A product reference number shall be given to the application upon payment confirmation. Payment has to be made within thirty (30) days from the date of approval for screening. The application form will be deleted from the system if payment has not been made within this stipulated time.
  • NON-SATISFACTORY - If the application is found incomplete during the screening process, the application shall be rejected and the applicant shall be notified via the system.

 

Note:

If there is any decision made by the applicant/ required by the Authority in certain cases to withdraw a submitted application for registration of a product, at any stage of evaluation prior to its approval, the applicant shall notify the Authority and shall state the reasons for the decision.

 

 

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.

Mobile Web :

Newsletter Subsription

Site Last Modified

  • Last Modified: Monday 17 December 2018, 11:54:20.
© Copyright 2018 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA

Main Menu English

Choose Your Language