RENEWAL

1. When should I submit the application for product registration renewal?

The renewal of product registration shall be submitted within six (6) months prior to the expiry of the validity period of a product registration.

2. How can I submit the application for product registration renewal?
3. What will happen if I did not submit the application for product registration renewal before product registration expiry date?
4. What is the fee for product registration renewal application?
5. Is the processing fee refundable if I would like to withdraw my product registration renewal application or if the product registration renewal application is rejected?
6. What are the requirements for product registration renewal?
7. How do I know if there is any comment(s) regarding my product registration renewal application?
8. Can I submit the applications for product registration renewal and variation concurrently?
9. After product registration renewal, how long is the product registration validity?
10. What will happen if I submit the product registration renewal application without fulfilling the requirements?
11. How do I know whether the product registration renewal application is approved or rejected by Drug Control Authority (DCA)?

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: Jumaat 19 Julai 2019, 16:49:18.
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