Application to amend the Poisons Standard
1 July 2010
This template is to be used for applications to change the Poisons Standard (currently the Standard for Uniform Scheduling of Drugs and Poisons No. 24) made independently of any associated product application that may be made to the TGA or the Australian Pesticides and Veterinary Medicines Authority. Use of this template will ensure that applications are in an acceptable format and will help avoid possible delays in their consideration. The template 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 <http://www.tga.gov.au/regulation/scheduling-policy-framework.htm>.
PLEASE NOTE: The decision-maker is required to consider the criteria set out under Section 52(E) of the Therapeutic Goods Act 1989 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 template. It is in your interests to pay particular attention to that section (Part 2) of the template that deals with these matters.
This application form in relation to an application for an amendment of the current Poison Standard was approved in writing by the delegate of the Secretary for the purposes of paragraph 52EAA(2)(a) on 1 July 2010.
Questions and comments regarding the template are to be directed to the Medicines and Poisons Scheduling Secretariat <http://www.tga.gov.au/ndpsc/index.htm#contactdetails>.