VARIATION

1. What is the procedure of Variation?

Variation shall be submitted online via Quest 3+. The requirements can be viewed in Malaysian Variation Guideline ( MVG).

2. What is the fee for variation applications?
3. How to make payment for a variation application?
4. What is the timeline for variation approval?
5. How many types of variation can be applied in one variation application?
6. Can a new variation type be added to an on-going variation application?
7. Can the payment be refunded if the application is rejected or withdrawn?
8. How to withdraw a variation application?
9. Which Type of variation should be submitted when the particular change we are applying for is not mentioned in the Malaysian Variation Guideline or one or more of the conditions cannot be fulfilled?
10. Does minor change under category MiV-N require official application through Quest system Variation Module or can applicant just notify NPRA without going through the system?
11. Can incomplete/on-going stability data be accepted in order to change storage condition as per Zone IV B requirement?
12. Can subsequent variation application be submitted while there is pending/on-going variation for the same product?
13. Is there a specified timeframe for implementing grace period for implementation variations to a registered product following NPRA’s approval of a variation?

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: Wednesday 21 August 2019, 09:55:47.
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