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Common Technical Document Module 1: OTC medicines

Applicable for applications lodged from 1 July 2017

10 July 2017

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Module 1.11 - Foreign regulatory information

This section holds documents relating to foreign regulatory information for a new medicine, or significant changes to a registered medicine.

You will not usually need to include information in Module 1.11 for a new OTC medicine application or a change to an existing OTC application but it may be relevant in certain circumstances. For example:

  • an application for a new medicine with a new active ingredient (a level N5 application) where simultaneous applications are being submitted in other countries
  • a new combination medicine (a level N5 application) where the combination is registered in another country.

We may ask you to provide information on the foreign regulatory status during the screening or evaluation phase of an application.

Module 1.11.1 Foreign regulatory status

Details of the foreign regulatory status may be included for some N4, N5, C3 or C4 level applications where the same or similar applications have been submitted in other countries or where the medicine in question is marketed in other countries.

What to include

Relevant information for inclusion in this module would include:

  • A list of countries in which a similar application has been submitted
  • A list of countries in which the proposed medicine or a similar medicine(s) is marketed
  • Details of approvals, deferrals, withdrawals or rejections of the application in other countries.

Module 1.11.2 Foreign product information

You may include foreign product information for some N4, N5, C3 or C4 level applications if the same or similar applications have been submitted in other countries or the medicine is marketed in other countries.

What to include

Include a copy of the equivalent overseas document to the Australian product information. For example, a data sheet from New Zealand or the prescribing information from United States of America.

Module 1.11.3 Data similarities and differences

You may include data similarities for some N4, N5, C3 or C4 level applications if the same or similar applications have been submitted in other countries or where the medicine is marketed in other countries.

What to include

Prepare a summary of the similarities/differences between the data in this application and the data packages submitted in the overseas country.

Identify and account for any significant differences.

Module 1.11.4 Foreign evaluation reports

You may include a foreign evaluation report for some N4, N5, C3 or C4 level applications if a regulatory authority in another country has evaluated the same or similar applications and the evaluation report is available.

What to include

Obtain a copy of the relevant evaluation report and include a complete copy of the report in this Module.

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