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:
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.