Submitting an application
The form provides applicants with more guidance when navigating through the form, a streamlined structure and format, and the ability to save incomplete forms that they wish to continue at another time.
Application to amend the Poisons Standard
About the application form
The form contains notes throughout each part to aid the applicant.
However, it is expected that in using this form, applicants have also familiarised themselves with the requirements set out in the Scheduling Policy Framework and the current version of the Poisons Standards.
Note
The decision-maker is required to consider the criteria set out under Section 52(E) of the Therapeutic Goods Act 1989 (the Act) which stipulates the matters which must be taken into account when changing the Poisons Standard.
Their ability to reach a decision to amend the Poisons Standard in response to your application will therefore be dependent upon your response to each of these matters, as set out in the application form.
The application form to amend the current Poison Standard was approved in writing by the delegate of the Secretary for the purposes of paragraph 52EAA(2)(a) of the Act on 22 December 2022.
When to use this application form
This application form is to be used for:
Applications to amend the current Poisons Standard (SUSMP), including scheduling, rescheduling and appendices, under s52EAA of the Act where an application is made independent of a product application to the Therapeutic Goods Administration (TGA). Please note that any proposal to amend the Poisons Standard in respect of the requirements for agricultural or veterinary chemical uses, including those affecting labelling or packaging should be made through the APVMA.
OR
- This application form is also for use by medicines sponsors who wish to change the current Poisons Standard under section 52EAA of the TG Act consistent with the process described in the Scheduling Handbook.