Other regulatory functions

Internal reviews

The APVMA had no internal reviews due in the September quarter 2017. There were 9 internal reviews active at the end of the September quarter 2017.

Internal reviews—September quarter 2017

Quarter

Decision due within the quarter

Finalised that were due within the quarter

Finalised within timeframe (%)

September 17

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

Chemical review continued to progress component assessments for the remaining fifteen 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.

GMP audit program

In the September quarter 2017, the APVMA completed 21 Good Manufacturing Practice (GMP) audits—15 in Australia and 6 overseas—with 95.2 per cent of GMP audits completed within timeframe.

GMP activity—September quarter 2017

Quarter

Audit location

Number completed

Within timeframe

Within one week of due date

September 17

Australia

15

93.3%

100%

Overseas

6

100%

100%

Total

21

95.2%

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 2017.

Notices issued—September quarter 17

Quarter

Issued

Finalised

Within timeframe

September 17

0

0

N/A

Total

0

0

N/A

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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