Other regulatory functions

1. Internal reviews

The APVMA had three internal reviews due in the December quarter 2016.

1.1. Internal reviews—December quarter 2016

Quarter Decision due Finalised Finalised within timeframe (%)
September 2016 1 0 0
December 2016 3 0 0

If an applicant is not satisfied with a decision made by the APVMA an internal review can be requested. These must be completed within 90 days.

2. Chemical reviews

The reconsideration of approvals and registrations of omethoate was completed in December 2016, bringing the number of reviews currently in progress down to 16.

In October 2016, dimethoate component reports (supplementary toxicology report; re-entry update to occupational health and safety report) and proposed regulatory decision report were published for consultation for a period of three months.

Paraquat toxicology report (3 volumes, includes neurotoxicology) was also published in October 2016.

A chemical review or ‘chemical reconsideration’ is where the APVMA reconsiders the registration of a chemical, if risks to safety and performance have been identified.

3. GMP audit program

In the December quarter 2016, the APVMA completed 21 good manufacturing practice (GMP) audits—16 in Australia and 5 overseas – with 85.7 per cent of GMP audits completed within timeframe.

3.1. GMP activity—December quarter 2016

Quarter Audit location Number completed Within timeframe Within one week of due date
1 Australia 19 94.7% 94.7%
Overseas 8 87.5% 87.5%
2 Australia 16 87.5% 100%
Overseas 5 80% 100%
Total 48 89.6% 95.8%

Good Manufacturing Practice (GMP) is part of quality assurance in the manufacturing process and relates to both production and quality control.

4. Compliance statutory notices

The APVMA issued one stop supply notice and one notice to produce in the December quarter 2016.

4.1. Notices issued—December quarter 2016

Quarter Issued Finalised Within timeframe
September 2016 0 0 N/A
December 2016 1 0* 100%
Total 2 0 100%

* Decision stayed by Administrative Appeals Tribunal

Compliance statutory notices are formal correspondence from the APVMA under the Agvet Code and include: stop supply or recall notices or substantiation notices. Notices are issued periodically throughout the year and must be published within 14 days.

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