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Submitting data in the eCTD format - Therapeutic Goods Administration - Australia

Updated: Aug 21, 2021

This information is for sponsors and manufacturers wanting to submit data in the electronic Common Technical Document (eCTD) format for a:

  • prescription medicine

  • biological

  • over-the-counter medicine

  • registered complementary medicine

  • assessed listed medicine

  • listed medicine ingredient

  • master file.

This guidance is:

  • a step-by-step guide on submitting an eCTD sequence to the TGA.

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