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General dossier requirements

27 July 2018

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Part B: Electronic dossiers

This guidance is for dossiers you intend to send to us electronically and needs to be used in conjunction with the Part A: Requirements for all dossiers.

If you cannot send the information to us electronically, please see guidance on Part E: Hard copy (paper) dossiers.

Text-searchable content

Your electronic dossier should be text-searchable.

Generate PDF documents from electronically-sourced documents. The following diagrams demonstrate the difference between searchable and non-searchable text in a PDF.

Figure 1 - This image demonstrates how we can use the search function to find content in a PDF that is text searchable

Figure 1 - the search function takes you through all of the instances of a string of characters within a text searchable PDF document

Figure 2 - This image shows the message received when trying to search for content when the text is not searchable in PDF documents. If you are not sure whether your text is searchable, try using this search function as a test.

Figure 2 - If the text of a PDF document is not searchable the following message appears when using the search function: 'Scanned Page Alert - this page contains only an image of a scanned page. There are no text characters...'

Routine exceptions include:

  • original certificates of analysis or certificates of suitability
  • signed letters of authorisation
  • labels and diagrams
  • original GMP certificate or licence
  • downloaded component documents of a literature search.

Folder and file names

Electronic folder and file names should indicate the content and allow documents to be easily identified within the structure of the electronic dossier.

Bookmarks and hyperlinks

Use specific settings when you create your PDF from a word document to ensure the hyperlinks will work in the PDF version.

This will greatly enhance our ability to find the relevant information and provide efficiencies with the evaluation process.

Use bookmarks to assist us to navigate around the document.

Organise the book marks like a table of contents and use them for sections, subsections figures, and appendices.

For example; use bookmarks for a summary document that has internal headings and subheadings.

For more information on creating bookmarks go to:

  • Electronic submissions
    • eCTD AU Module 1 and regional information
    • AU NeeS specification: Module 1 and regional information.

'Not applicable' content

Do not create any of the following if a folder or document is not applicable to your dossier:

  • place holder(s)
  • 'empty' folder(s) or document(s)
  • blank 'not applicable' pages, within a document.

Security on electronic files

Security on electronic files inhibits our ability to access information. For this reason do not use:

  • application- or file-level security
  • one-time security settings
  • password protection on any files
  • security settings to lock files or folders, including passwords, certificate security, or adobe settings.

If there is pre-existing security on literature references, do not apply any further security.

Submitting your electronic dossier

You can submit your electronic dossier by one of the following two ways:

Figure 3 - Online submission: The preferred method of delivery where available.

Figure 3

Figure 4 - Electronic media delivery: Dossier copied to media; mediatransported; and delivered to the TGA. (NB: Media supplied to the TGA will not be returned.)

Figure 4

Online submission

Currently our online submissions are limited to OTC medicines, but will become our preferred option as our online services develop.

If you have not used our online services previously, follow our guidance - online services getting started with TGA - and complete an access request form

Electronic media delivery

You can send one electronic copy of your dossier using one set of the following media:

  • single-sided CD-R or DVD-R (single or dual layer)
  • USB flash drive
  • USB external hard drive.

Figure 5 - If more than one unit of media is required, ensure you use a single type of media.

Figure 5 - ensure you use only a single type of media when submitting your electronic dossier

Use the least number of media units possible - Figure 5 demonstrates the use of one USB external hard drive, making it unnecessary to use more than one unit of media.

Your electronic dossier forms part of our official record and we cannot return the media to you.

Do not use:

  • double-sided discs
  • more than one type of media - see Figure 5
  • zip files (unless requested)
  • email (unless requested).
If more than one unit of media is needed

Avoid spanning the content of a part, or a section, of the dossier over two units.

Labelling the media

Create and attach a label for each unit of media with the following information:

  • TGA reference/application number(s) - if we have already provided one
  • eSubmission Identifier (for NEES and eCTD format dossiers)
  • applicant's name
  • product name(s) (where relevant)
  • proposed ingredient name (for listed medicine ingredient applications)
  • approved name of the active substance(s) (AAN, ABN, etc. as applicable) (all medicines)
  • total number of CDs or DVDs or USB flash drives or USB hard drives
  • an indication of its place within the set - for example, 1/3, 2/3, 3/3. Choose electronic media that results in the minimum number of media units possible.
USB flash drives

Make sure the label is packaged with the USB flash drive to reduce the risk of separation.

Package all media to protect it during transport.

Email

For some prescription medicine application types, you can submit the dossier to eSubmissions@health.gov.au provided that:

  • the email contains a single compressed (zipped) attachment that, in combination with the email, is less than 30 MB
  • AND
  • the dossier is a valid eCTD or NeeS sequence

In the subject line of the email, include:

  • eSubmission identifier
  • sequence number
  • sequence type
  • regulatory activity number (if applicable)
  • approved name or product name

Organisations can register for secure email (Transport Layer Security). Signing up for secure email ensures a more efficient and cost effective means of correspondence between TGA and applicants during the prescription medicines streamlined submission process.

For more information on how to use secure email when corresponding with TGA go to TGA eBusiness Services and select 'secure email' in the left column.

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