Transitional arrangements for applications and reconsiderations
This content only applies to transitional applications that were received before 1 July 2014. The content will be relevant for these applications until 30 June 2015. For information about what will happen to your application from 1 July 2015, please refer to transitinal arrangements information published May 2015.
The Agricultural and Veterinary Chemicals Legislation Amendment Bill 2013 and the Agricultural Veterinary Chemicals Legislation Amendment (2013 Measures No. 2) Regulations 2013 contains transitional arrangements to allow the APVMA to effectively and efficiently deal with applications and reconsiderations (chemical reviews) that are in progress when the new legislation commences on 1 July 2014. The ‘old legislation’ refers to the legislation that was in effect immediately before 1 July 2014.
The transitional arrangements for an application for approval of an active constituent, registration or a chemical product, approval of a label for a chemical product, variation of an approval or registration or approval of a permit are outlined on this page. The content in the ‘Transitional arrangements’ section of the website is relevant only to applicants who have applications that fit into point two below.
- An application lodged on or after 1 July 2014 will be determined under the new legislation.
- An application lodged before 1 July 2014, for the first 12 months, will be determined under the old legislation.
- An application lodged under section 10 or 27 before 1 July 2014 will be only be determined under the old legislation if a notice under section 11A (an acknowledgement letter or a deficiency letter) has been issued in relation to that application before 1 July 2014.
- From 1 July 2015 any applications that were lodged before 1 July 2014 and have not yet been determined will be transition to the new legislation and be determined under the new legislation.
- If there is an outstanding notice on one of these applications the new legislation will not apply until the applicant has complied with the notice or the due date for a response in the notice has passed – whichever comes first.
- When an application transitions, the remaining assessment period will be calculated as the new assessment period less the old assessment period, and this will apply from the date the application was accepted into evaluation, less any clock off time. If there is an outstanding notice the new assessment period will not apply until the applicant has complied with the notice or the due date for a response in the notice has passed – whichever comes first.
- Despite transitional arrangements for the new legislation on 1 July 2015, an application lodged before 1 July 2014 will not be subject to new information requirements. That is to say the APVMA cannot retrospectively impose new information requirements on a pre-1 July 2014 application that met the previous information requirements at the time it was lodged.
- The limits on use of information (data protection) provisions under the old legislation will continue to apply for an application that is to be determined under the old legislation, until that application is finalised, regardless of the finalisation date.
The transitional arrangements for a reconsideration (chemical review) of an approved active constituent, registered chemical product or approved label are outlined below:
- A reconsideration that commences on or after 1 July 2014 will be concluded under the new legislation.
- A reconsideration that commences before 1 July 2014, for the first 12 months, will be concluded under the old legislation.
- Any reconsiderations commenced before 1 July 2014 and not concluded before 1 July 2015 will be transitioned to the new legislation.
- When a reconsideration transitions, the remaining reconsideration assessment period is calculated using the new legislative formula for the period within which the APVMA is to conclude a reconsideration, however only the necessary components of the reconsideration will apply. For example if the reconsideration requires a toxicology assessment and a residues assessment and the toxicology assessment has been completed before 1 July 2015, toxicology will not form part of the new reconsideration period.
- The protected information arrangements for a reconsideration are based on the date the information is provided to the APVMA, not when the reconsideration begins.
- The old legislative protected information provisions will apply to information submitted in relation to a reconsideration were the information is provided to the APVMA before 1 July 2014.
- The new legislative protected information provisions will apply to information submitted in relation to a reconsideration were the information is provided to the APVMA after 1 July 2014.
An approval, registration, permit or licence that was in force under the old legislation before the commencement of the new legislation on 1 July 2014 continues to be in force. Any existing conditions of an approval, registration, permit or licence that were imposed by the APVMA under the old legislation will also continue to apply after the new legislation commences on 1 July 2014 until the conditions are successfully varied.