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.

On this page: Text-searchable content | Folder and file names | Bookmarks and hyperlinks | 'Not-applicable' content | Security on electronic files | Submitting your electronic dossier

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 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.

Routine exceptions include:

• original certificates of analysis or certificates of suitability
• signed letters of authorisation
• labels and diagrams
• original GMP certificate or licence.

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 further information on creating bookmarks go to Appendix 7 of the ICH eCTD specifications and the TIGes Harmonised NeeS guidance document version 4.0.

'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:

• online submission

OTC medicines as an attachment to the electronic application. 'Zip' the entire dossier and upload it as a single attachment provided it is less than 100MB.

If the 'zipped' file is larger than 100MB, send to us electronically by following the guide on electronic media delivery

• electronic media delivery.

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

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.)

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

All other dossiers can be sent to us using electronic media delivery.

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.

Use the least number of media units possible - figure 4 demonstrates the use of one USB external hard drive, making it unnecessary to use more than one unit of media.

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)
• AAN of the active substance(s) (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.