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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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Submitting an application

Send your application form and relevant attachments to the Medicines Shortages Section by:

  • email (preferred): medicine.shortages@tga.gov.au
  • post: Medicines Shortages Section, Pharmacovigilance and Special Access Branch, TGA, PO Box 100, Woden ACT 2606, Australia
  • courier: Medicines Shortages Section, Pharmacovigilance and Special Access Branch, TGA, 136 Narrabundah Lane, Symonston 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 usually 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:

  1. sponsor of the medicine that is unavailable or in short supply
  2. applicants with arrangements in place with the sponsor of the medicine that is unavailable or in short supply
  3. other applicants.

An effective application is one that:

Fees

No fees are payable for applications to import and supply medicines under section 19A in the interests of public health.

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