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OTC new medicines registration process

27 August 2020

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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.

Patent certification under the Australia/USA free trade agreement

You need to provide a patent certificate under subsection 26B(1) of the Therapeutic Goods Act 1989 or notification that this is not required before the medicine can be registered on the ARTG.

If you have not already provided the patent certificate or notification form with your application, complete either the:

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:

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:

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.

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