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CTD Module 1: Administrative information and prescribing information for Australia

This guidance explains the administrative and prescribing (dossier) information you need to support the registration of a prescription medicine. It also applies to varying the details of an Australian Register of Therapeutic Goods (ARTG) registration for a prescription medicine.

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Purpose

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.

Legislation

Guidance

This Guidance is presented as a downloadable file because of its length. 

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Page history

Show all page updates (11)

Migration to new 'Guidance' content type:

  • Consistent ‘Purpose’ heading.
  • ‘Legislation’ section to clearly show which laws the Guidance relates to.
  • ‘Page history’ section replaces document version history.

V4.3, Minor editorial changes.

Author: Prescription Medicines Authorisation.

V4.2, Minor correction to application lodgement.

Author: Prescription Medicines Authorisation.

V4.1, Updated to remove 'minor' from variations.

Author: Prescription Medicines Authorisation Branch/Scientific Evaluation Branch.

V4.0, Updated to:

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

Author: Prescription Medicines Authorisation Branch/Scientific Evaluation Branch.

V3.0, Third version to reflect electronic dossiers.

Author: Medicines Authorisation Branch.

V2.9, Revisions to align with introduction of eCTD format.

Author: Office of Medicines Authorisation.

V2.2, Alignment with revised PPF, editorial changes.

Author: Office of Medicines Authorisation.

V2.1, Editorial amendments.

Author: Office of Medicines Authorisation.

V2.0, Second version to reflect outcomes from the public and stakeholder consultation and the revised prescription medicine registration process.

Author: Office of Medicines Authorisation.

V1.0, First version.

Author: Office of Medicines Authorisation.

Migration to new 'Guidance' content type:

  • Consistent ‘Purpose’ heading.
  • ‘Legislation’ section to clearly show which laws the Guidance relates to.
  • ‘Page history’ section replaces document version history.

V4.3, Minor editorial changes.

Author: Prescription Medicines Authorisation.

V4.2, Minor correction to application lodgement.

Author: Prescription Medicines Authorisation.

V4.1, Updated to remove 'minor' from variations.

Author: Prescription Medicines Authorisation Branch/Scientific Evaluation Branch.

V4.0, Updated to:

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

Author: Prescription Medicines Authorisation Branch/Scientific Evaluation Branch.

V3.0, Third version to reflect electronic dossiers.

Author: Medicines Authorisation Branch.

V2.9, Revisions to align with introduction of eCTD format.

Author: Office of Medicines Authorisation.

V2.2, Alignment with revised PPF, editorial changes.

Author: Office of Medicines Authorisation.

V2.1, Editorial amendments.

Author: Office of Medicines Authorisation.

V2.0, Second version to reflect outcomes from the public and stakeholder consultation and the revised prescription medicine registration process.

Author: Office of Medicines Authorisation.

V1.0, First version.

Author: Office of Medicines Authorisation.

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