Companies seeking pre-application assistance from the APVMA should note that any assistance given is not legally binding with regard to any future applications concerning the product/permit/active application, on the part of
APVMA (or it's Agencies) nor on the applicant. Furthermore, any assistance provided cannot be taken as being indicative of any future agreed position on data requirements or regulatory decision.
The pre-application assistance
provided by the APVMA is explicitly based on the questions and documentation submitted by the company at the time of seeking assistance, and cannot account for future changes and developments made by the applicant, scientific knowledge or
regulatory requirements. Applicants should note that the assistance provided is without prejudice to applicable legislation relating to the particulars and documents which should be submitted in support of a product/permit/active application;
it is also without prejudice to any intellectual property rights of third parties. Applicants should also note that any assistance provided by the APVMA in relation to a request for assistance for a future application is not challengeable
by the applicant or any other third party.