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CTD Module 1

Administrative information and prescribing information for Australia - Applicable to applications received by the TGA from 9 February 2018

23 December 2020

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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

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

Updated to include
-requirements for the COR report-based process, Priority review registration process, remove Category 2 application requirements and align with version 3.1 of the eCTD regional specifications.

Prescription Medicines Authorisation Branch/Scientific Evaluation Branch 09/02/2018
V4.1 Updated to remove 'minor' from variations Prescription Medicines Authorisation Branch/Scientific Evaluation Branch July 2019
V4.2 Minor correction to application lodgement Prescription Medicines Authorisation August 2020
V4.3 Minor editorial changes Prescription Medicines Authorisation December 2020

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