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
Prior TGA approval required?
A change made under section 9D or section 23 of the Act.
Safety Related Request: a change made under section 9D(2) of the Act.
Self Assessable Request: a change made under section 9D(1) or section 9D(3) of the Act.
Notifications: a change made under section 9D(2C) of the Act. TGA approval is made automatically upon lodgement and payment of the application.
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.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.