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OTC new medicines registration process
Step 12 - Finalising your OTC registration
This step involves finalising the registration once a decision has been made on whether to register an OTC medicine.
Decision to register the medicine
If the decision is to register the medicine, we will send you the decision letter.
This letter will include decisions made by the delegate of the Secretary to impose standard and specific conditions on the registration of your medicine in the register, under Section 28 of the Therapeutic Goods Act 1989.
It is important that you read, understand and comply with these conditions.
If you do not comply with any one of these conditions of registration, your medicine may be cancelled from the ARTG under section 30(1)(da) of the Act.
Related information and guidance
Patent certification under the Australia/USA free trade agreement
If you have not already provided the patent certificate or notification form with your application, complete either the:
- Approved form for notification that 26B(1) certificate is not required
- The relevant approved subsection 26B(1)(a) or (b) certificate.
Send us the completed and signed notification form or certificate by email, quoting the application submission number.
Once we receive the completed and signed notification form or patent certificate:
- We will register the medicine on the ARTG
- You can download your certificate of registration from Business Services. To do this, follow the guidance on printing your ARTG certificate.
Date of effect of the registration
The registration of your medicine will commence on the day specified in the certificate of registration. The medicine cannot be lawfully imported, exported or supplied by the applicant prior to this date.
Decision not to register the medicine
If the decision is not to register the medicine, the decision letter will include both:
- A statement of the reasons for the decision
- Information on your rights to seek a review of the decision
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.