About the application form
Use of this application form will ensure that applications are in an acceptable format and will help avoid possible delays in their consideration. 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.
PLEASE 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 must 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.
Submitting an application
The application form to amend the current Poisons Standard has recently been updated. It is now accessible as an electronic form on the TGA’s consultation hub.
The new 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.
Applicants are requested to submit new applications through the electronic form at the following link:
Application to amend the Poisons Standard
While applicants are transitioning to the new form and the TGA is gathering feedback on it, the old application form may continue to be used until 3 March 2023. If you have already completed or are currently using the old application form, you may still wish to proceed to submit it. The old application form can be downloaded below.
Questions and comments regarding applications are to be directed to the Medicines and Chemicals Scheduling Secretariat.