Include a list of attachments so that we can verify that the full application has been received.
Emails should not exceed 20Mb; please provide attachments as a zip file or in multiple emails if needed.
We will send you an email to confirm that your application form and attachments have been received.
Send us an email or phone +61 2 6232 8850 if you are unable to supply all requested information, or if you have questions regarding your submission.
When the TGA receives multiple applications
We often only grant one approval if we receive more than one application in relation to the same medicine shortage or unavailability. We will only grant approval to subsequent applications if demand is likely to exceed what can be supplied under the initial approval.
Applicants who have the ability to manage the supply chain during a shortage are preferred. Therefore, preference will be given to effective applications in the following order:
sponsor of the medicine that is unavailable or in short supply
applicants with arrangements in place with the sponsor of the medicine that is unavailable or in short supply
If there are multiple applications to mitigate the same shortage, we may also consider other factors in deciding which 19A application(s) to progress. These include considerations such as: similarity of the proposed 19A product to the Australian product, whether medicine is approved in a specified country, labelling and packaging and presence of declarable substances.
No fees are payable for applications to import and supply medicines under section 19A in the interests of public health.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.