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Changing an OTC medicine: using the Changes Tables

Version 2.4, 4 December 2017

4 December 2017

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Status codes

Status codes relating to the type of application needed to make a change to a registered OTC medicine, including the status code, whether TGA approval is needed before the change can be made and the type of application needed either an application for an new ARTG entry or to change the existing entry
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.
O No

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.

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