Other regulatory functions

1. Internal reviews

The APVMA had 1 internal review due in the June quarter 2017. There were 9 internal reviews active at the end of the June quarter 2017.

1.1. Internal reviews—June quarter 2017

Quarter

Decision Due within the Qtr

Finalised that were due within the Qtr

Finalised within timeframe (%)

Sep 16

1

0

0

Dec 16

3

0

0

Mar 17

2

0

0

Jun 17

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.

2. Chemical reviews

In April 2017 the APVMA published the chlorpyrifos toxicology assessment.

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.

3. GMP audit program

In the June quarter 2017, the APVMA completed 21 Good Manufacturing Practice (GMP) audits—17 in Australia and 4 overseas – with 85.7 per cent of GMP audits completed within timeframe.

3.1. GMP activity—June quarter 2017

Quarter

Audit location

Number completed

Within timeframe

Within one week of due date

Sep 16

Australia

19

94.7%

94.7%

Overseas

8

87.5%

87.5%

Dec 16

Australia

16

87.5%

100%

Overseas

5

80%

100%

Mar 17

Australia

17

71%

88%

Overseas

4

100%

100%

Jun 17

Australia

17

94%

100%

Overseas

4

50%

50%

Total

90

86%

93%

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 notice to produce in the June quarter 2017.

4.1. Notices issued—June quarter 2017

Quarter

Issued

Finalised

Within timeframe

Sep 16

0

0

N/A

Dec 16

2

0*

100%

Mar 17

1

0

N/A

Jun 17

1

0

N/A

Total

4

0

100%

* Decision stayed by 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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