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General dossier requirements

27 July 2018

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Part E: Hard copy (paper) dossiers

This 'Hard copy (paper) dossiers' guidance is provided as an interim only, as we move towards electronic submissions as the method for submitting all applications.

This guidance:

  • applies only if you cannot submit your dossier either by online submission or by electronic media delivery - for example, CD, USB drive or external hard drive
  • needs to be used in conjunction with the Part A: Requirements for all dossiers.

Number of copies

We only need a single hard copy, and you can print the pages on both sides.

Headers and footers (all dossiers)

Page numbering

Do ensure:

  • each document is numbered sequentially and divided from other documents by a tab
  • page numbering at the document level not at the volume (binder) level
  • all documents have page numbers.

Do not number:

  • the application consecutively, by page
  • documents with more than one set of page numbers.

Paper size, margins and printing (all dossiers)

Figure 7 - Example of 2-ring binder,
opened and laid out flat
Figure 7

Use standard A4 paper for all dossiers (hard copy and electronic).

Prepare text and tables using margins so that you do not loose content when printing on A4 paper and make sure:

  • the left-hand margins are wide enough for ring-binder holes
  • binders can be opened and laid flat - see Figure 7

When you print double-sided documents make sure:

  • margin spaces are wide enough so that information is not obscured when the page is placed in a binder
  • both sides of each page are numbered

Binding (all dossiers)

Present the information in binders (referred to as volumes) when the content exceeds 20 sheets of paper - includes responses to our requests for information.

The binders need to have durable covers and enable us to disassemble and reassemble the content.

Ensure the external dimensions of binders do not exceed:

  • 270 mm in width
  • 320 mm in height
  • 80 mm in thickness.

Do not submit information that is either:

  • stapled
  • contained in plastic sleeves.

Identifying volumes

Label each volume on the front, back and spine of the binder and include the following information for each volume:

  • name of sponsor
  • name of medicine or subject of other application types (e.g. name of proposed listed medicine ingredient)
  • application number (when provided by the TGA)
  • module and volume number
  • content of volume - expressed as CTD document(s), if this format is used.

Packing your paper dossier

Submission of an electronic dossier is always preferred. Do not submit a paper dossier if you are able to submit an electronic dossier.

When you prepare a paper dossier to send to us:

  • Use boxes to pack dossiers consisting of more than two binders.
  • Make sure:
    • the binders fit into boxes
    • the boxes are strong enough to protect the contents during transport.
  • Pack the binder with the spines to the sides or bottom of the box to prevent the binders coming open.
  • Use bubble, plastic or shrink wrap around the sides of the box to protect the folders.
  • Number each box sequentially, with box 1 containing Volume 1 of Module 1 and write the contents (including type of dossier) for each box on both the box label and module.
  • See guidance on where to send your dossier for the postal and delivery address.

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