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This application is a service of the Singapore Government.

Frequently Asked Questions

Health Products Regulation

Therapeutic Products > Therapeutic Product Registration > Making amendments to current TP Registration

1.
How do I apply for a variation to my existing product registration? How many can I submit at one time?

Please refer to the Guidelines on Therapeutic Product Registration in Singapore 2016. The maximum number of concurrent submissions is as follows:

MAV-1:  3

MAV-2: 1

MIV-1: 5

MIV-2: 1

2.
Is there a specified timeframe for implementing grace period for implementation variations to a registered product following HSA’s approval of a variation?

There is no specified timeframe for implementation of variations after they have been approved. However, the approved variations should be implemented by the next importation of the product.

FAQs