Site notifications

Sub menu

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 or variation of a prescription medicine. 

Published
Last updated

Note

This Guidance is directly referenced in legislation and must be presented in its original publication format. 

Legislation

Downloads

Product types
Featured in

Page history

Show all page updates (10)

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.

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.