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CTD Module 1: Administrative information for registered complementary medicines

Australian regulatory guidance

Guidance for applicants on information required for Module 1 in dossiers for applications for registered complementary medicines to be consistent with the Common Technical Document (CTD) format.

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Note

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

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Show all page updates (1)

Version 1

Information for original publication extracted from pages 156 - 159 and 175 - 184 of ARGCM V8.0.

New introductory paragraph.

Module 1.0.3 ‘Responses to request for information’ added.

Information on comparable overseas bodies included under Module 1.2.

CTD module 1.2.5 modified to include information on the new electronic online submission and process change for applying for restricted representation approvals.

Explanatory text added for Modules 1.2.6, 1.5.7 and 1.5.8.

Data matrix moved to back of document. Module 1.2.5 removed from matrix as the form for a restricted representation is no longer submitted with a RCM application.

Version 1

Information for original publication extracted from pages 156 - 159 and 175 - 184 of ARGCM V8.0.

New introductory paragraph.

Module 1.0.3 ‘Responses to request for information’ added.

Information on comparable overseas bodies included under Module 1.2.

CTD module 1.2.5 modified to include information on the new electronic online submission and process change for applying for restricted representation approvals.

Explanatory text added for Modules 1.2.6, 1.5.7 and 1.5.8.

Data matrix moved to back of document. Module 1.2.5 removed from matrix as the form for a restricted representation is no longer submitted with a RCM application.