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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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Change table: Other

Other changes to OTC medicines, including change codes, the change that can be made using this code, the status of the code, the assurance code, the application level for the change and the section of the therapeutic goods act that applies to the change
Change codes Other Status codes Assurance codes Application level Applicable section of the Act
CTA Correction of ARTG record in accordance with section 9D(1) of the Therapeutic Goods Act 1989. Evidence to support the change is included with the application SAR 5, 21 C1 9D(1)
CAO Correction of ARTG record in accordance with section 9D(1) of the Therapeutic Goods Act 1989. An application using this change code must include written advice from the TGA advising the use of this change code for the requested change to the product SAR (fee exempt) 5, 21, 31 C1 9D(1)
OT1 'Other' changes - application level C1. An 'other' code is used only when no other code applies. An application using OT1 must include written advice from the TGA advising the use of this change code for the requested change to the product ASK 31 C1 Specified in advice from TGA
OT2 'Other' changes - application level C2. An 'other' code is used only when no other code applies. An application using OT2 must include written advice from the TGA advising the use of this change code for the requested change to the product ASK 31 C2 Specified in advice from TGA
OT3 'Other' changes - application level C3. An 'other' code is used only when no other code applies. An application using OT3 must include written advice from the TGA advising the use of this change code for the requested change to the product ASK 31 C3 Specified in advice from TGA
OT4 'Other' changes - application level C4. An 'other' code is used only when no other code applies. An application using OT4 must include written advice from the TGA advising the use of this change code for the requested change to the product ASK 31 C4 Specified in advice from TGA
IHN Update of ingredient name/s on labelling/Product Information in accordance with the TGA's International Harmonisation of Ingredient Names (IHIN) project. SAR (Fee Exempt) 5 C1 9D(1)

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