FAQ Vet - Variation

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?

For Minor Variation- Notification: FOC
For Minor Variation- Prior Approval: RM150/ application
For Major Variations: RM300/ application

3. How to make payment for a variation application?

Payments for variation applications are done online.

Applicant is advised to refer to FAQ for Quest3+.

4. What is the timeline for variation approval?

For Minor Variation- Notification: Within 20 working days provided that the notification fulfils all the requirements as per guidelines
For Minor Variation- Prior Approval: Within 45 working days following receipt of an application, provided that the application fulfils all the requirements as per guidelines
For Major Variations: Within 60 working days following receipt of an application, provided that the application fulfils all the requirements as per guidelines

Applicants are advised to refer Malaysian Variation Guidelines for details.

5. How many types of variation can be applied in one variation application?

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

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 Can the payment be refunded if the application is rejected or withdrawn?

No.

8. How to withdraw a variation application?

Applicant may withdraw any variation application by clicking a withdraw button.

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?

No. Register as a new application.

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?

All Minor Variation Notification should be applied through the Quest3+.

11. Can incomplete/on-going stability data be accepted in order to change storage condition as per Zone IV B requirement?

Currently, Zone IVB is not enforced for Veterinary products.

12. Can subsequent variation application be submitted while there is pending/on-going variation for the same product?

No.

13. Is there a specified timeframe for implementing grace period for implementation variations to a registered product following NPRA’s approval of a variation?

Within 6 months after the product registration holder has been informed of the approved variations.

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