FAQ Vet - Renewal

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?

The application for product registration renewal shall be submitted and herein paid via National Pharmaceutical Regulatory Agency’s (NPRA) QUEST online registration system.

3. What will happen if I did not submit the application for product registration renewal before product registration expiry date?

After the product registration expiry date, the status of product registration shall be automatically changed to ‘expired’. Applicant will not be able to submit the application for product renewal.

4. What is the fee for product registration renewal application?

The renewal processing fee for poison/non-poison product is RM1000 per product

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?

All processing fees submitted to NPRA are non-refundable.

6. What are the requirements for product registration renewal?

For Veterinary product registration renewal application, please refer to Registration Guideline of Veterinary Products ( REGOVP).

7. How do I know if there is any comment(s) regarding my product registration renewal application?

Applicant can check on the comments from the ‘remarks’ column in product registration renewal module in QUEST online registration system.

8. Can I submit the applications for product registration renewal and variation concurrently?

Variation should be done before the renewal submission.

9. After product registration renewal, how long is the product registration validity?

Registration of a product shall be valid for five (5) years or such a period as specified by the Authority (unless suspended or cancelled by the Authority).

10. What will happen if I submit the product registration renewal application without fulfilling the requirements?

The application for product registration renewal shall only be submitted when all of the requirements for product registration renewal have been complied with. Failure to do so shall result in the product registration renewal application being rejected by the Authority.

11. How do I know whether the product registration renewal application is approved or rejected by Drug Control Authority (DCA)?

The product registration renewal status can be viewed from QUEST online registration system List of Renewal Approved Veterinary products.

For rejected applications, letter of rejection with reason(s) of rejection will be sent to the product registration holder after the rejection of product registration renewal.

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