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APVMA couldn’t meet timeframe targets due to legislation transitionqrcode

Dec. 8, 2015

Favorites Print Dec. 8, 2015
The Australian Pesticides and Veterinary Medicines Authority (APVMA) received 1388 applications for product registration, variation to registration or label approval for pesticide products in 2014–15 ended June 30th, 2015. This is 29% less than in the previous year. There were 89 pesticide product applications transitioned to the new legislation in July 2015. 

Applications for pesticide product registration or variation, 2014–15
Applications
2013–14
2014–15
% change
Applications in progress at beginning of period
1039
1107
+6
Applications received
1942
1388
-29
Applications finalised
1870
1843
-2
Applications in progress at end of period
1107
657
-41%

In 2014–15, APVMA completed 651 applications within the statutory timeframe for applications received before 1 July 2014 (74% compared with a target of 90%), and completed 844 applications within the statutory timeframe for applications received after 1 July 2014 (88% compared with a target of 100%). Timeframe performance targets were not met in 2014–15, primarily because of the significant effort required to implement the new legislation and to run two registration systems in parallel. 

Pesticide product finalisations, 2014–15
Applications
2013–14
2014–15
Total finalised
Total finalised
Finalised in timeframe
Finalised in timeframe (%)
Received before 1 July 2014
1870
883
651
74
Received after 1 July 2014
0
960
844
88
Total
1870
1843
1495
81

 The Agricultural and Veterinary Chemicals Legislation Amendment Act 2013 was implemented on 1 July 2014. The aim of the legislative reforms was to improve the efficiency and effectiveness of agvet chemical registration and review processes. The process improvement initiatives APVMA has implemented will continue to improve ability to meet timeframe performance targets. APVMA is also implementing new arrangements under the reform legislation for applicants to seek assistance before applying, which are designed to streamline the application process and improve the quality of applications.
 
In 2014–15, APVMA received 418 permit applications and finalised 456 permits, of which 70% were completed within the statutory timeframe. Of the permit applications finalised, approximately 46% were for minor use, 30% were for reissue of a previous permit, 2% were for export use, 7% were for emergency use and 14% were for other use (eg research).
 
The focus this year was to finalise as many applications as possible that were already in progress on 1 July 2014, to reduce the number of applications that would need to be transitioned to new arrangements on 1 July 2015. The timeframe statistics for these older applications was 44% within the timeframe, compared with 80% last year. This change reflects the significant additional work required to finalise legacy applications under the previous system. For applications received after 1 July 2014, 84% of active constituent approvals were completed within the timeframe, compared with the target of 100%.
 
Chemical review
 
The APVMA undertook 284 regulatory actions for chemical reviews in 2014–15. 

                    Regulatory actions following chemical review, 2014–15
Chemical
Actives
Products
Labels
Affirm
Vary
Cancel
Affirm
Vary
Cancel
Affirm
Vary
Cancel
2,4-d
 
 
3
 
 
 
 
 
 
Azinphos-methyl
1
 
 
 
 
 
 
2
 
Dichlorvos
 
 
 
 
 
3
 
3
 
Fenthion
 
 
1
 
 
8
 
 
13
Haloxyfop
 
 
 
 
 
 
 
 
10
Profenofos
 
 
 
 
 
 
 
4
1
Note: no changes (affirm); changes to approval or registration (vary); no further approval or registration (cancel).

At any time, either within or outside the review process, the APVMA can suspend approvals or registrations for a specified period. At the same time, instructions for use (where appropriate) are issued when there is an immediate concern that can be managed in the short term. Suspensions can also be put in place to allow for relevant trial work to generate results needed for consideration or to provide additional information within specific timeframes. There were 71 regulatory decisions made in 2014–15.

Suspensions following chemical review, 2014–15
Chemical
Actives
Products
Labels
S
Rs
Cs
S
Rs
Cs
S
Rs
Cs
Dimethoate
 
 
 
 
1
13
 
 
24
Quintozene
 
 
1
 
 
10
 
 
22
Note: S= Suspend ; Rs= Revoke suspension; Cs= Continue  suspension

Financial performance
 
APVMA’s total income for this financial year was Aus$29.741 million, an increase of Aus$1.466 million (5.18%) from the previous year. This increase is largely due to the lower than normal result in 2013–14 when Aus$2.0 million was returned to the budget as part of the Better Regulations reform funding agreement.
 
Total operating expenses for 2014–15 were Aus$33.204 million, an increase of Aus$1.207 million (3.77%) from the previous year.

APVMA financial performance for 2014–15
Income source
Income (Aus$’000)
%
Receipts from industry
 
 
Application fees
5554
18.68
Levies
16263
54.68
Annual fees (renewal fees)
4703
15.81
Other receipts from industry
1921
6.46
Parliamentary appropriation
743
2.50
Other revenue
557
1.87
Total income
29741
100.00
 
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Source: APVMA

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