Other regulatory functions

Internal reviews

The APVMA had 0 internal review due in the March quarter 2018. There were 3 internal reviews active at the end of the March quarter 2018.

Internal reviews—March quarter 2018

Quarter

Decision Due within the Qtr

Finalised within the Qtr

Finalised that were due within the Qtr

Finalised within timeframe (%)

September 2017

0

2

N/A

N/A

December 2017

1

4

0

0

March 2018

0

1

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.

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 fifteen chemical reviews.

On 25 January the Polihexanide Proposed Regulatory Decisions report was published for a consultation period of three months.

GMP audit program

In the March quarter 2018, the APVMA completed 10 Good Manufacturing Practice (GMP) audits—9 in Australia and 1 overseas—with 86 per cent of GMP audits completed within timeframe.

GMP activity—March quarter 2018

Quarter

Audit location

Number completed

Within timeframe

Within one week of due date

September 2017

Australia

15

93%

100%

Overseas

6

100%

100%

December 2017

Australia

7

86%

100%

Overseas

4

50%

50%

March 2018

Australia

9

89%

100%

Overseas

1

100%

100%

Total

42

88%

95%

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 notice published in the March quarter 2018.

Notices issued—December quarter 2017

Quarter

Issued

Finalised

Within timeframe

September 17

0

0

N/A

December 17

1*

0

N/A

March 18

0

0

N/A

Total

1*

0

N/A

*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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