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Section 19A: Guidance for industry

Supplying substitute medicines when registered medicines are unavailable or in short supply

4 January 2018

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Who can make a section 19A application

Any person can make an application to import and supply medicines that are not included in the ARTG in the interests of public health to:

  • address a medicine shortage or unavailability of a medicine included in the ARTG

    OR

  • allow early access to a medicine under evaluation for inclusion in the ARTG.

Note: You do not need to be the sponsor of the medicine that is unavailable or in short supply to make an application. However, you do need to be in a position to advise the TGA about the availability of the medicine included in the ARTG.

Once approval has been granted, the section 19A approval holder is the sponsor of that medicine and is required to adhere to the obligations of sponsors. Ensure that you are capable of adhering to these obligations before applying for approval to import and supply medicines under section 19A.

Generally, it will be sufficient for the Secretary to grant only one person a section 19A approval to address a specific medicine shortage.

For more information go to When we receive multiple applications.

 

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