Other regulatory functions

1. Internal reviews

The APVMA had 1 internal review due in the March quarter 2017.

1.1. Internal reviews—March quarter 2017

Quarter

Decision Due

Finalised

Finalised within timeframe (%)

Sep 16

1

0

0

Dec 16

3

0

0

Mar 17

2

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

The reconsideration of approvals and registrations of dimethoate was completed in March 2017, reducing the number of reviews currently in progress down to fifteen.

In March 2017, the APVMA published its final regulatory position report for glyphosate following a comprehensive assessment of the International Agency for Research on Cancer (IARC) report and other recent assessments of glyphosate. The APVMA concluded that the use of glyphosate in Australia does not pose a cancer risk to humans.

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 March quarter 2017, the APVMA completed 21 good manufacturing practice (GMP) audits—17 in Australia and 4 overseas – with 76.1 per cent of GMP audits completed within timeframe.

3.1. GMP activity—March 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%

Total

69

84.6%

94.2%

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 March quarter 2017.

4.1. Notices issued—March quarter 2017

Quarter

Issued

Finalised

Within timeframe

Sep 16

0

0

N/A

Dec 16

2

0*

100%

Mar 17

1

0

N/A

Total

3

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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