Send your application form and relevant attachments to the Medicines Shortages Section by:
Email (preferred):
Section19ASubmissions@Health.gov.au
Post:
Medicines Shortages Section
Pharmacovigilance Branch, TGA
PO Box 100
Woden ACT 2606
Australia
Courier:
Medicines Shortages Section
Pharmacovigilance Branch, TGA
27 Scherger Drive
Fairbairn ACT 2609
Australia
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
- other applicants.
An effective application is one that:
- has been completed in full
- provides all relevant attachments
AND
- meets the criteria for approval.
- 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.
Fees
No fees are payable for applications to import and supply medicines under section 19A in the interests of public health.