Application to amend the Poisons Standard
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 template, 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 regarding your application will therefore be dependent upon your response to each of these matters, as set out in the application form. It is in your interests to pay particular attention to that section (Part 2) that deals with these matters.
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 14 March 2011.
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 the 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,'Reconsideration of substances from prescription to OTC classification'.
Submitting an application
Medicines in conjunction with a product application
Applications submitted by medicines sponsors who wish to change the current Poisons Standard at the same time as lodging a submission for the registration of a medicine with the TGA must be sent electronically, on CD or DVD, to:
The Director
Applications Management and Exports
Medicines Authorisation Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Medicines independent of a product application
All other medicines applications i.e. made independently of any product application to the TGA, must be sent electronically (by email) to:
The Secretary
Medicines Scheduling Secretariat
medicines.scheduling@tga.gov.au
All non-medicine applications
These applications must be sent electronically to:
The Secretary
Chemicals Scheduling Secretariat
chemicals.scheduling@health.gov.au
Application form
Questions and comments regarding the template are to be directed to the Medicines and Poisons Scheduling Secretariat.