Justification for a particular route of evaluation

Schedule 10 to the Therapeutic Goods Regulations

29 November 2015

This guidance has been updated and this webpage will be archived on 1 March 2016.

Please go to Pathways to evaluating your medicine for the updated guidance which you can commence using.

This form should be completed by or for each applicant who wishes to have their product or substance evaluated by an area of the TGA other than as specified in Schedule 10 to the Therapeutic Goods Regulations.

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.

How to access a pdf or Word document