This content is current only at the time of printing. This document was printed on 25 September 2018. A current copy is located at https://apvma.gov.au/node/26401
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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 (%)|
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|
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
* 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.