AU NeeS specification: Module 1 and regional information

This guidance:

• needs to be used in conjunction with the General dossier requirements
• provides general information on producing an electronic copy of a dossier in the NeeS format
• relates to preparing and structuring the data to be submitted in an electronic format to support applications to:
  • register a medicine under Section 23 of the Therapeutic Goods Act 1989 (the Act)
  • vary the registration of a medicine Section 9D of the Act.

The NeeS specification is an interim arrangement as applicants plan the move to full eCTD.

Difference between NeeS and eCTD

NeeS differs from the eCTD format in that NeeS does not have:

• the following two XML files that provide the backbone of Modules 1 to 5:
  • the index.xml
  • au-regional.xml
• the util folder.

The navigation through a NeeS format dossier is based on:

• electronic tables of contents
• bookmarks
• hypertext links.

Organising NeeS submissions

All dossiers must be structured in accordance with the Common Technical Document (CTD) format, a format Australia initially adopted in 2004.

How to access a pdf document

For electronic dossiers using the NeeS format:

• Use the CTD folder structure as detailed in the Annex to the ICH guideline Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use (pdf, 286kb).
• Make sure the breakdown of the electronic submission conforms with the ICH Granularity Document (the Annex to the Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use).
• Follow the ICH and AU eCTD file naming conventions.