Other regulatory functions

Internal reviews

The APVMA had no internal review due in the September quarter 2018. There were four internal reviews active at the end of the September quarter 2018.

Internal reviews—September quarter 2018

Quarter

Decision due within the Qtr

Finalised within the Qtr

Finalised that were due within the Qtr

Finalised within timeframe (%)

September 2018

0

0

N/A

N/A

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.

Chemical reviews

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.

The APVMA continued to progress component assessments for the remaining thirteen active chemical reviews.

On 27 August 2018 the Methiocarb Proposed Regulatory Decisions report was published, for a consultation period of three months.

GMP audit program

In the September quarter 2018, the APVMA completed 18 Good Manufacturing Practice (GMP) audits—12 in Australia and 6 overseas—with 100 per cent of GMP audits completed within timeframe.

GMP Activity—September quarter 2018

Quarter

Audit location

Number completed

Within timeframe

Within one week of due date

September 2018

Australia

12

12

100%

Overseas

6

6

100%

Total

18

18

100%

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

Compliance statutory notices

There were no statutory notices published in the September quarter 2018.

Notices issued—September quarter 2018

Quarter

Issued

Finalised

Within timeframe

September 2018

2

2

100%

Total

2

2

100%

*Notice published following determination of the Administrative Appeals Tribunal.

Compliance statutory notices are formal correspondence issued periodically throughout the year from the APVMA under the agvet code and include stop supply or recall notices or substantiation notices.

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