Other regulatory functions

Internal reviews

The APVMA had 1 internal reviews due in the December quarter 2017. There were 4 internal reviews active at the end of the December quarter 2017.

Internal reviews—December quarter 2017

Quarter

Decision due within the quarter

Finalised that were due within the quarter

Finalised within timeframe (%)

September 2017

0

N/A

N/A

December 2017

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 30 November 2017 the macrolide antibiotics (kitasamycin, oleandomycin and tylosin) Proposed Regulatory Decisions report was published for a consultation period of three months.

GMP audit program

In the December quarter 2017, the APVMA completed 11 Good Manufacturing Practice (GMP) audits—7 in Australia and 4 overseas—with 72.7 per cent of GMP audits completed within timeframe.

GMP activity—December 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%

December 17

Australia

7

85.7%

100%

Overseas

4

50%

50%

Total

32

87.5%

93.8%

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 was one statutory notices published in the December quarter 2017.

Notices issued—December quarter 17

Quarter

Issued

Finalised

Within timeframe

September 2017

0

0

N/A

December 2017

1*

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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