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CTD Module 1.5 - Assessed listed medicines - Restricted information certification form

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Please refer to the Data Protection Scheme for Assessed Listed Medicines Guidance document on the TGA website for more information on restricted information.

Complete this form as per the instructions in Appendix 1 of the Data Protection Scheme for Assessed Listed Medicines guidance on the TGA website.

Please include this form in CTD Module 1.5 of your application dossier.

This form is divided into two parts:

Part Instruction

A - Reliance on restricted information declaration

Complete one Part A for each application

The information you provide in Part A relates to a certification that:

  1. you are not seeking to rely on restricted information to support your application; OR
  2. the person (i.e. sponsor) who is the owner of the restricted information [relating to another L(A) medicine] has given the Secretary of the TGA permission to rely on that information to support your application along with details of this information.

Part A also requires you to include a list of all information provided to support this application.

B - Eligibility for information to be restricted

Complete one Part B for each application

The information you provide in Part B relates to whether any of the information provided in your application would be eligible to be considered restricted information.

Restricted information certification form

This form is available in pdf and Microsoft Word formats. The pdf form can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.

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