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Part 3: Other timeframe performance results
Other regulatory decisions – 8L, 8M, 8P,?notifiable variations?and item 25
The APVMA undertakes a range of other regulatory activities, including the creation of or changes to the holder or nominated agent (item 8L, 8M, 8P), technical assessments on data packages (item 25) and minor changes to the details of a registered product, active or label (notifiable variations).?
Notifiable variations were introduced on 1 January 2015 and are now shown separately in the APVMA product application statistics. This has reduced the number of product applications shown to be commenced by 736 in 2015–16, as shown in the below table.
The use of notifiable variations is a successful introduction of a new low regulatory approach. These variations take effect on the day the notice is lodged. Before their introduction, these changes were requested via an application under items 12, 13A or 14. This change has significantly decreased the time in which they are completed.
Workload and performance of other regulatory decisions July 2015 – June 2016
|Assessment type||Received||Finalised||In progress||Finalised within timeframe (%)|
Items 8L, 8M, 8P
Consents to import
Consents to import?are issued?to allow importation—in limited circumstances—of unregistered products or unapproved actives into Australia when a legitimate reason exists for a person or company to have possession of the chemicals in Australia, eg for research, chemical trials or special veterinary applications in zoos. There is no statutory timeframe for consents to import, however, the APVMA seeks to process them within 14 days.
Between July 2015 and June 2016, the APVMA processed 608 consents to import, with 86 per cent processed within 14 days.
Import consents processed and performance for July 2015 – June 2016
|Quarter||Received||Finalised||Finalised within timeframe (%)||Issued||In progress|
An internal review?is a request sent to the APVMA from an external person/company appealing the APVMA’s decision to refuse or place onerous conditions on their application to register an Agvet chemical as per sections 166–167 of the Agvet Code. They must be completed within 90 days.
Twenty-two applications were made for internal reviews between July 2015 and June 2016, as shown in the table below. Sixteen reviews were finalised, with no further action taken on two applications—one application was received ‘out of time’ and the APVMA no longer held jurisdiction to determine the other application.
The timeframe performance was 63 per cent.
Workload and performance for internal reviews July 2015 – June 2016
|Quarter||Received||Finalised||WIP||Finalised within timeframe (%)|
A chemical review or ‘chemical reconsideration’ (Agvet Code ss31-34) is a process whereby the APVMA reconsiders the registration of an Agvet chemical/s in the marketplace if potential risks to safety and performance have been identified. The maximum timeframe for any review is 57 months. But each chemical review has its own timeframe which is usually less than the maximum timeframe allowed.?
There is a new process for chemical reviews as adopted with the introduction of the new legislation on 1 July 2014. Chemical reviews commenced before 1 July 2014 and not concluded by 30 June 2015 are now considered under the current legislation.
There were no chemical reviews due for completion under the new arrangements between 1 July 2015 and 30 June 2016.?However, the APVMA completed and published the Fenamiphos review on 28 July 2015. As a result of the review the APVMA took the following regulatory actions:
- cancellation of one product used on turf
- variation of the label of the fenamiphos granular product to update the safety directions, warnings and restraints and to delete all use patterns except strawberry runners
- variation of the label of the fenamiphos emulsifiable concentrate products to update the safety directions, warnings and restraints and to delete all use patterns except aloe vera planting material and banana planting material.
There are 16 reviews currently in progress. In the reporting period the following component reviews were completed:
- Nov 2016 – omethoate (OH&S)
- March 2016 – omethoate (residues)
- April 2016 – maldison (chemistry)
- May 2016 – omethoate (preliminary review decision).
GMP audit program
Good Manufacturing Practice (GMP) is part of quality assurance in the manufacturing process to ensure products are consistently manufactured to the appropriate standards in accordance with their registration particulars and specifications. GMP is concerned with both production and quality control. It is a means of giving consumers confidence that the products meet the required quality standards, are safe and reliable for the purposes for which they are intended.
The GMP audit program completed 96 audits in 2015–16, 78 in Australia and 18 overseas. Of these audits, 80 per cent were completed within the required timeframe and 89 per cent completed within one week of the due date.?
Workload and timeframe performance for the GMP Audit Program July 2015 – June 2016
|Quarter||Audit location||Number completed||Within timeframe (%)|
Compliance statutory notices
Compliance statutory notices are formal correspondences issued from the APVMA under the Agvet Chemical Code, including: stop supply or recall notices (s100) or substantiation notices (s69ENA, s69ENB, s145GA, s145GB). Notices are issued periodically throughout the year and must be published within 14 days (s104).
The APVMA issued and published?one compliance statutory notice between July 2015 and June 2016.
Workload and performance for statutory notices July 2015 – June 2016
|Year to date||Issued||Finalised||Within timeframe (%)|
|July 2015 – June 2016||1||1||100|
Certificates of export
Before accepting exports of a chemical product from Australia, many countries require an assurance from the government authority responsible for regulating the product in Australia. This is provided by the APVMA in the form of a certificate of export. There are no statutory timeframes for the APVMA to process these. Between July 2015 and June 2016, the APVMA issued 429?certificates of export.
Certificates of export processed July 2015 – June 2016?
|Received||Issued||Not issued||In progress|