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Prescription medicine registration form & guide

This form should be used to apply for registration or to vary the conditions of registration for prescription medicines in Australia.

Sponsors should note that although this form allows electronic completion, the completed application form must still be submitted in hardcopy with the application to the address detailed on the front of the form.

This 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 document

Application for the registration, or to vary the conditions of registration, of prescription medicines (pdf,322kb)

New drugs and variation to existing drugs - Guide for sponsors (pdf,49kb)