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
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.