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Process to change a registered OTC medicine
Step 13 - Finalising your application
Decision to vary the entry on the ARTG
If the decision is to change the entry in the ARTG for your OTC medicine, under section 9D of the Therapeutic Goods Act 1989, you will receive the decision letter. For changes processed as notifications, this decision letter will be automatically generated once payment has been processed.
Decision not to vary the entry on the ARTG
If the decision is not to vary the entry in the ARTG, the decision letter will include both:
- a statement of the reasons for the decision
- information on your rights to appeal the decision. See TGA internal review guideline.
Applications made under section 23 of the Act
If your application included a change code corresponding to section 23 of the Act, go to Step 12 of the OTC medicine registration process for information on finalising your application.
Related information and guidance
Uploading PI/CMI documentation
Only some OTC medicines have approved PI/CMI documents. Sponsors may choose to publish these on the PI/CMI search facility on the TGA website.