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Submit data in Non-eCTD electronic Submission (NeeS) format

Find out how to submit data in the NeeS format.

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You can use the NeeS format for:

  • biologicals
  • over-the-counter medicines
  • registered complementary medicines
  • assessed listed medicines
  • ingredients for listed medicines.

You cannot use NeeS for:

  • prescription medicine applications (including master files) where eCTD has been mandated
  • medical devices
  • Good Manufacturing Practice (GMP) applications.

Before you submit

You'll need a TGA Business Services client account. See TGA Business Services: getting started with the TGA.

Data requirements

Prepare your sequence using the technical requirements outlined in the TGA NeeS Module 1 v2.0.1 specification.

Content requirements for sequences vary by therapeutic good and application type. Refer to relevant therapeutic area guidance for details:

Submit your sequence

Follow the same process as eCTD to submit your NeeS sequence. For more information, read Submit data in electronic Common Technical Document (eCTD) format.

Get help

For help with submitting a sequence, email eSubmissions@health.gov.au.

For help with eCTD specifications, email EDR@health.gov.au.

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