This content is current only at the time of printing. This document was printed on 19 September 2020. A current copy is located at http://www.xlg888.com/node/15116
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Advice directly to applicants
During May 2015 the APVMA wrote to people with applications affected by the transitional arrangements to provide a list of unfinalised applications and to explain what would happen to these applications from 1 July 2015.
For those applications which remained unfinalised on 1 July 2015 the APVMA has recalculated the timeframes and notified individual applicants in writing.
General advice to industry about the steps taken to transition applications from the old law to the new law was included in the Regulatory Update newsletter and this content has been updated to address common questions.
View the status of your application
From 1 July 2015 you will be able to see the product name and number and the new status of the application by logging into APVMA online services.
The Agricultural and Veterinary Chemicals Legislation Amendment Bill 2013 and the Agricultural Veterinary Chemicals Legislation Amendment (2013 Measures No. 2) Regulations 2013 included transitional arrangements to assist industry and the APVMA to manage applications and reconsiderations (chemical reviews) which were in progress when the ‘new law’ came into effect on 1 July 2014.
Between 1 July 2014 and 30 June 2015 those applications and reconsiderations which fell into the transitional arrangements have continued to be assessed under the legislation in effect immediately before 1 July 2014, the ‘old law’. From 1 July 2015 any of these applications or reconsiderations which are not finalised will be assessed under the Agvet Code legislation currently in place, the ‘new law’.
All applications submitted before 1 July 2014, and which remained unfinalised on 1 July 2015 were potentially affected—including active approvals, product applications, variations and permits.
Affected applications with outstanding notices or letters will be administered under the previous law only until the applicant has complied with the notice, or the due date for a response has passed—whichever comes first—after which they will be administered under the new law.
All other affected applications to approve an active constituent, register a product, approve a label, make a variation or to issue a permit, will now be administered under the new law.
The APVMA?has written?to people with affected applications to advise recalculated timeframes.
The formula for calculating the remaining assessment is the new assessment period less any days elapsed from the old assessment period. The days elapsed from the old assessment period means the days that have passed 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.
Regulation 84 of the Agvet Code Regulations sets out the formula for calculating the assessment periods for affected applications which were not finalised by 30 June 2015.
The formula calculates how many days are left of the assessment clock at 1 July 2015.
How new timeframes are to be calculated in accordance with the following formula:
(P x 30) – (O – R)
O means the number of days in the period starting on the day the assessment period for the application commenced under regulation 78 or 78A of the old Code (the commencement date) and ending on 30 June 2015?(being day one of the evaluation period up to 30 June 2015).
P means the number of months within which the APVMA would have been required to determine the application, under subregulation 76(1) or (1A), if the application had been made on or after 1 July 2014.
R means the number of days in the period starting on the commencement date and ending on 30 June 2015 to which no regard was to be had, under paragraph 165(2)(a) of the Old Code, in working out the period within which the application was to be determined under the old Code.
Example timeframe calculations
Some typical examples of new timeframe calculations:
|Applicaton||Entered evaluation||Clock stop||Old code timeframe||Approximate due date||New code timeframe||Approximate due date||Note|
|Item 1||10 June 2014||No||15 months||10 September 2015||18 months||
10 December 2015
|The timeframe for an item 1 increased by 3 months from 1 July 2014|
|Item 3||10 June 2014||Notice sent and clock stopped for 60 days||15 months plus 60 days||10 November 2015||25 months (being 18 plus 7)||30 August 2016||The timeframe for an item 3 increased by 3 months from 1 July 2014. Also as a section 159 notice was sent from 1 July 2014 that also adds an additional 7 months to the timeframe.|
|Item 2||10 June 2014||No. Modules 2.1, 3.1, 5.2, 6.1, 7.1, 8.2 and 11.1 applied||15 months||10 September 2015||16 months||10 October 2015||?|
|Item 2||10 June 2014||Notice sent and clock stoped for 60 days. Modules 2.1, 3.1, 5.2, 6.1, 7.1, 8.2 and 11.1 applied||15 months plus 60 days||10 November 2015||22 months (being 16x1.1/3+1)||10 June 2016||The modular timeframe increased by 1 month from 1 July 2014. Also as a section 159 notice was sent the timeframe extends by one and one third x the modular assessment period rounded up to the nearest month plus 1 month.|
|Item 7||1 May 2015||No||3 months||1 August 2015||3 months||1 August 2015||Timeframe for item 7 applications did not change.|
|Item 7||1 May 2015||Notice sent and clock stopped for 30 days||3 months plus 30 days||1 September 2015||5 months (3 months + 2 months)||1 October 2015||From 1 July 2014 where a section 159 notice is sent for an item 7 application the timeframe is extended from 3 months to 5 months.|
Information requirements and data
From 1 July 2015 the APVMA can only take into consideration information already provided, or that is provided in response to a notice or letter issued by the APVMA that requires the information, or extends an invitation for the information to be submitted.
This means you can no longer volunteer data or information for any application.
Applications that were lodged before 1 July 2014 will remain subject to the application requirements that were in place at the time the application was made. The APVMA cannot impose the application requirements that commenced on 1 July 2014 to an application made before 1 July 2014.
The limits on use of information arrangements that were in place under the previous legislation—previously known as data protection—will continue to apply for applications lodged before 1 July 2014 that are determined after 1 July 2015 under the current law. The limits on use of information arrangements under the current law only apply to applications lodged after 1 July 2014.
The Agvet Code requires the APVMA to meet the prescribed application timeframes. Under the new law applicants can give written notice to have an application treated as refused and seek review of the decision from the Administrative Appeals Tribunal, where the APVMA does not determine the application in the required timeframe.?
Fit and proper person
From 1 July 2015 a fit and proper person declaration is required in relation to all permit applications. During assessment of the permit application the APVMA will contact you directly to complete this declaration.
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.
If conditions were imposed under the old legislation these will continue to apply unless the conditions are successfully varied.