Compile an electronic Common Technical Document (eCTD) baseline sequence

Provide as much content as possible in your baseline sequence.

When preparing the sequence:

• use the sequence type 'Baseline' (seq-type-46)
• use the sequence description 'Reformat' (seq-desc-25)
• relate the baseline to itself
• use the therapeutic area prefix as the submission number
• add documents in the appropriate part of the dossier with the operator 'new'
• do not provide any other information within this sequence.

Submit a complete baseline with modules 1, 2, 3, 4, and 5. If this is not possible, at a bare minimum, include:

Cover letter

• identify the sequence as an eCTD baseline
• list products and ARTG numbers
• confirm there are no content amendments
• submission date of the previous dossier(s)
• assurance that all information in the baseline was in the previous dossier(s)
• assurance that any omissions do not mislead.

Tracking table

• Include NeeS tracking table history if applicable.

Approved details

• product information
• consumer medicine information
• labelling
• pharmacovigilance information (e.g., risk management plan)
• and module data for future references.

We do not evaluate the baseline, and you don't need to include hyperlinks between documents.

There are 3 types of baseline sequences:

Initial baseline sequence

A baseline submitted as the initial eCTD sequence is known as an initial baseline sequence.

Initial baseline sequences should be sequence number [0000].

Submit the first new regulatory activity (e.g., next variation) as sequence 0001.

Mid-baseline sequence

If an initial baseline sequence is not possible, you can submit a mid-baseline sequence later in the eCTD lifecycle.

Only provide baseline documents where no current content exists in the eCTD lifecycle. Do not replace current content with baseline content.

Multiple baseline sequence

You can submit a baseline in multiple sequences. For example, one sequence for Modules 4 and 5, and another sequence for Module 3.

• Use the sequence type 'Baseline' in each sequence
• Ensure the related sequence references itself in the envelope metadata.

You may transition to eCTD without a baseline sequence.

Submit your first sequence as [0001] to indicate no baseline has been provided.

In the cover letter state that the dossier has been transitioned with no baseline.

When referencing documents from the NeeS dossier, provide a table in Module 1.0.1 with the following information:

• submission number
• sequence number
• file name and node
• page number.

Include the NeeS sequence history in the tracking table.

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

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