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Withdraw information from your electronic Common Technical Document submission (eCTD)

How to withdraw information from your electronic Common Technical Document (eCTD) dossier.

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You can withdraw information from your eCTD by submitting an eCTD withdrawal sequence, including:

  1. removing some or all products from a dossier.
  2. withdrawing a submission under evaluation.
  3. withdrawing part of a regulatory activity.

An eCTD withdrawal sequence:

  • reverts the dossier to a previous state,
  • ensures the dossier matches the ARTG (Australian Register of Therapeutic Goods) or provisional ARTG records.

When submitting a withdrawal, do not provide any new information.

Remove all products from a dossier

When you have a dossier with multiple products and you intend to cancel all of them, submit an entire product lifecycle withdrawal sequence.

Submit this sequence after you request to cancel an ARTG entry.

When preparing the sequence:

  • provide the finalised TBS (TGA Business Services) cancellation in Module 1.0.1
  • use the sequence type 'Product Withdrawal' (seq-type-57)
  • use the sequence description 'Withdrawal' (seq-desc-23)
  • relate the sequence to itself
  • use the therapeutic area prefix as the submission number.

Remove some products from a dossier

When you have a dossier with multiple products and you intend to cancel some (but not all) of them, submit a partial product lifecycle withdrawal.

Submit this sequence after you request to cancel an ARTG entry.

When preparing the sequence:

  • list cancelled products, ARTG numbers, documents, and tradenames in the cover letter
  • remove documents related to the cancelled products (e.g. labels) from the dossier
  • update documents to remove references to the cancelled products and note these documents in the cover letter
  • provide the finalised TBS (TGA Business Services) cancellation in Module 1.0.1
  • use the sequence type 'Undefined regulatory activity*' (seq-type-52)
  • use the sequence description 'Withdrawal' (seq-desc-23) in v3.1 or 'Partial Withdrawal' (seq-desc-27) in v3.2 or later
  • relate the sequence to itself
  • use the therapeutic area prefix as the submission number.

Withdrawing a submission under evaluation

To remove all information about a submission under evaluation, submit a submission withdrawal.

Notify us at eSubmissions@health.gov.au first.

When preparing the sequence:

  • provide the withdrawal email notification in Module 1.0.1
  • do not remove withdrawn sequences from the tracking table
  • use the sequence type of the initial sequence used for the submission - for example, 'Extension of Indication' (seq-type-5)
  • use the sequence description 'Withdrawal' (seq-desc-23)
  • relate the sequence to the initial sequence
  • you don’t have to delete withdrawn documents from the dossier.

Withdrawing part of a regulatory activity

To remove some information about a regulatory activity under evaluation, submit a partial submission withdrawal.

This includes:

  • withdrawing some applications from a submission
  • withdrawing some submissions from a bundled minor variation

Notify us at eSubmissions@health.gov.au first.

When preparing the sequence:

  • provide the withdrawal email notification in Module 1.0.1
  • do not remove withdrawn sequences from the tracking table
  • use the sequence type 'Supplementary information' (seq-type-45)
  • use the sequence description 'Withdrawal' (seq-desc-23) in v3.1 or 'Partial Withdrawal' (seq-desc-27) in v3.2 or later
  • relate the sequence to the initial sequence
  • you don't have to delete withdrawn documents from the dossier.

Get help

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

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

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