CTD Module 1

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Administrative information and prescribing information for Australia

30 June 2015

Module 1 of the CTD describes the administrative information and prescribing information (for example, the application form, the proposed product information and labelling) for Australia to support:

  • the registration of a prescription medicine under section 23 of the Therapeutic Goods Act 1989 ('the Act')
  • the variation of the details of an ARTG registration for a prescription medicine under section 9D of the Act.

This guidance:

  • explains the format and content for Module 1 of a dossier
  • describes each document in Module 1
  • outlines when each document needs to be provided
  • details any other requirements relating to the documents.

Further information

Dossier document matrix

A summary of CTD document requirements for applications to the TGA is shown in the eSubmission Document matrix, available at: Australian eCTD regional specification and validation criteria 3.0

Regulatory requirements

The following documents provide further information about the regulatory requirements for applications for prescription medicines:

Version history
Version Description of change Author Effective date
V1.0 First version Office of Medicines Authorisation 28/09/2007
V2.0 Second version to reflect outcomes from the public and stakeholder consultation and the revised prescription medicine registration process. Office of Medicines Authorisation 16/05/2013
V2.1 Editorial amendments Office of Medicines Authorisation 30/05/2013
V2.2 Alignment with revised PPF, editorial changes. Office of Medicines Authorisation 30/04/2014
V2.9 Revisions to align with introduction of eCTD format Office of Medicines Authorisation 05/09/2014
V3.0 Third version to reflect electronic dossiers Medicines Authorisation Branch 01/07/2015

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