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Changing an OTC medicine: using the Changes Tables
Version 2.4, 4 December 2017
|Code||Prior TGA approval required?||Description|
|A||Yes||A change made under section 9D or section 23 of the Act.|
|SRR||Yes||Safety Related Request: a change made under section 9D(2) of the Act.|
|SAR||Yes||Self Assessable Request: a change made under section 9D(1) or section 9D(3) of the Act.|
|N||Yes||Notifications: a change made under section 9D(2C) of the Act. TGA approval is made automatically upon lodgement and payment of the application.|
|NEW||Yes||New application for registration required.|
The TGA does not need to be informed of changes subject to status code 'O' - no application is submitted.
Nb. 1. Change codes for 'O' status changes are not included in the application portal.
Nb. 2. Changes with status 'O' have been included for clarity and completeness and do not imply that this information is required for evaluation of an equivalent new product.
|ASK||Yes||This applies only where one of the 'other' change codes (OT1, OT2, OT3 or OT4) is used. Refer to the Changes not included in the Changes Table for guidance.|