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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 or variation of a prescription medicine. 

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

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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.

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