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Performance statistics July–September 2016: Part 3 – other timeframe performance results
During this quarter the APVMA:
- commenced 275 regulatory decisions for 8L, 8M, 8P, notifiable variations and item 25
- processed 141 consents to import and 92 per cent were processed within 14 days
- received one request for an internal review
- completed 27 good manufacturing practice (GMP) audits—19 in Australia and 8 overseas
- 92.6 per cent of GMP audits were completed within timeframe
- issued 64 certificates of export.
Other regulatory decision – 8L, 8M, 8P, notifiable variations and item 25
Workload and performance of other regulatory decision July–September 2016
| Assessment type | Commenced | Finalised | In progress | Finalised within timeframe (%) |
|---|---|---|---|---|
| Technical assessment | 1 | 5 | 9 | 80 |
| Items 8L, 8M, 8P | 105 | 53 | 80 | 64 |
| Notifiable variations | 169 | 80 | 88 | 100 |
Background information
Other regulatory decisions and activities can include:
- changing (or creating) a holder or nominated agent?(item 8L, 8M, 8P)
- technical assessments?on data packages (item 25)
- minor changes to the details of a registered product, active or label (notifiable variations).
Notifiable variations were introduced on 1 January 2015 and are shown separately.
Notifiable variations are a successful introduction of a new low regulatory approach. These variations take effect on the day the notice is lodged.
Before their introduction, these changes were requested via an application under items 12, 13A or 14. This change has significantly decreased the time in which they are completed.
Consents to import
Import consents processed and performance for July–September 2016
| Quarter | Received | Finalised | Issued | In progress | Finalised within timeframe (%) |
|---|---|---|---|---|---|
| 1 | 148 | 141 | 132 | 17 | 92 |
| Total | 148 | 141 | 132 (93%) | 17 | 92 |
Background information
Consents to import?are issued?to allow importation—in limited circumstances—of unregistered products or unapproved actives into Australia, when a legitimate reason exists for a person or company to have possession of the chemicals in Australia.
There is no statutory timeframe for consents to import—the APVMA seeks to process these within 14 days.
Internal reviews
Workload and performance for internal reviews July–September 2016
| Quarter | Received | Finalised | WIP | Finalised within timeframe (%) |
|---|---|---|---|---|
| 1 | 1 | 0 | 1 | 0 |
| Total | 1 | 0 | 1 | 0 |
Background information
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
There were no chemical reviews due for completion between 1 July and 30 September 2016.
There are?17 reviews currently in progress. There were no component reviews completed during this period.
In September 2016 the APVMA released a regulatory position on glyphosate for stakeholder consultation—this was not a formal reconsideration.
Background information
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
Workload and timeframe performance for the GMP audit program July–September 2016
| Quarter | Audit location | Number completed | Within timeframe (%) | Within one week of due date (%) |
|---|---|---|---|---|
| 1 | Australia | 19 | 94.7 | 94.7 |
| Overseas | 8 | 87.5 | 87.5 | |
| Total | 27 | 92.6 | 92.6 | |
Background information
Good Manufacturing Practice?(GMP) is part of quality assurance in the manufacturing process and relates to both production and quality control.
Compliance statutory notices
Workload and performance for statutory notices July–September 2016
| Quarter | Issued | Finalised | Within timeframe (%) |
|---|---|---|---|
| 1 | 0 | 0 | N/A |
| Total | 0 | 0 | N/A |
Background information
Compliance statutory notices are formal correspondence from the APVMA under the Agvet Code and include: stop supply or recall notices or substantiation notices.
Notices are issued periodically throughout the year and must be published within 14 days.
Certificates of export
Certificates of export processed July–September 2016
| Received | Issued | Not issued | In progress |
|---|---|---|---|
| 60 | 64 | Nil | 3 |
Background information
Before accepting exports of a chemical product from Australia many countries require an assurance from the government authority responsible for regulating the product in Australia. This is provided by the APVMA in the form of a certificate of export.
There are no statutory timeframes for the APVMA to process these but we try to complete them within 20 working days.