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Analysis by type of application
1. Summary of activities related to regulatory decisions—September quarter 2018
|
Types of regulatory decisions* |
Commenced |
Finalised/issued |
In progress |
|---|---|---|---|
|
Pre-application assistance |
53 |
31 |
21 |
|
Product registration—pesticides |
289 |
309 |
477 |
|
Product registration—veterinary medicines |
253 |
248 |
296 |
|
Actives |
62 |
274 |
146 |
|
Permits |
153 |
165 |
152 |
|
Items 8L, 8M, 8P |
144 |
154 |
36 |
|
Technical assessment (Item 25) |
6 |
2 |
9 |
|
Notifiable variations |
192 |
191 |
1 |
|
Import consents |
215 |
210 |
7 |
|
Certificates of export |
158 |
149 |
8 |
|
Total |
1525 |
1733 |
1153 |
*See description of?application types
1.1. Applications processed—September quarter 2018
|
? |
Commenced |
Finalised |
Finalised within timeframe |
2017–18 in timeframe |
In Progress |
In progress still within timeframe |
|---|---|---|---|---|---|---|
|
Pesticides |
289 |
309 |
80% |
63% |
477 |
89% |
|
Veterinary medicines |
253 |
248 |
88% |
81% |
296 |
70% |
|
Total Products |
542 |
557 |
83% |
70% |
773 |
81% |
|
Permits |
153 |
165 |
79% |
67% |
152 |
90% |
|
Actives |
62 |
274 |
99% |
86% |
146 |
84% |
|
Total |
757 |
996 |
86% |
73% |
1071 |
83% |
2. Pre-application assistance
In the September quarter 2018:
- 631 were received
- 634 were processed
- 99 per cent were completed within the 30-day timeframe.
2.1. Pre-application assistance—September quarter 2018
|
? |
Received |
Finalised |
Within timeframe |
In progress |
|---|---|---|---|---|
|
Tier 1 (1 month) |
21 |
14 |
93% |
6 |
|
Tier 2 (2 months) |
30 |
17 |
76% |
12 |
|
Tier 3 (3 months) |
2 |
0 |
N/A |
3 |
|
Total |
53 |
31 |
84% |
21 |
* This includes all PAAs received under the previous process.
Pre-Application Assistance (PAA)?is an optional, three-tiered, fee-based service provided to applicants to provide them with advice before they submit an application for registration. The timeframe for each tier is based on the complexity of the proposed application and effort required to provide the assistance.
3. Preliminary assessment
In the September quarter 2018:
- 631 were received
- 634 were processed
- 99 per cent were completed within the one month timeframe.
3.1. Preliminary assessment—September quarter 2018
|
Application Type |
Received |
Completed |
Refused |
Withdrawn |
Within timeframe |
|---|---|---|---|---|---|
|
Pesticides |
300 |
296 |
1 |
1 |
99% |
|
Veterinary medicines |
106 |
119 |
0 |
0 |
99% |
|
Total Products |
406 |
415 |
1 |
1 |
99% |
|
Permits |
167 |
157 |
0 |
2 |
100% |
|
Actives |
58 |
62 |
0 |
1 |
96% |
|
Total |
631 |
634 |
1 |
4 |
99% |
Preliminary assessment?is a legislatively required administrative check of all applications received to ensure the information necessary to proceed to a full evaluation is present.??The APVMA must complete a preliminary assessment of an application within one month after it is lodged.
4. Applications commenced
In the September quarter 2018, 757 applications were commenced
- 542 for products
- 62 for actives
- 153 for permits
5. Applications finalised
In the September quarter 2018, 996 applications were finalised
- 557 for products
- 274 for actives
- 165 for permits
Timeframe performance
In the September quarter 2018, timeframe performance results for applications were:
- 80 per cent for pesticide products
- 88 per cent for veterinary medicines products
- 96 per cent for actives
- 79 per cent for permits
Work in progress
At the end of September quarter 2018, there were:
- 1071 applications in progress
- 773 product applications
- 152 active applications
- 146 permit applications
- 83 per cent were within timeframe
Work in progress is an indicator of the current workload of the APVMA. It is calculated as the number of applications still in evaluation at the end of the quarter.
Technical assessment, notifiable variations, holders and nominated agents
In the September quarter 2018:
- 8 technical assessments on data packages were finalised
- 212 applications to change (or create) a holder or nominated agent?(item 8L, 8M, 8P) were finalised
- 126 minor changes to the details of a registered product, active or label (notifiable variations) were finalised.
5.1. Other regulatory assessments—September quarter 2018
|
Assessment type |
Commenced |
Finalised |
In progress |
Finalised within timeframe (%) |
|---|---|---|---|---|
|
Technical assessment |
6 |
2 |
9 |
0% |
|
Items 8L, 8M, 8P |
144 |
154 |
36 |
85% |
|
Notifiable variations |
192 |
191 |
1 |
100% |
6. Consents to import
In the September quarter 2018, 208 consents to import were issued.
6.1. Consents to import—September quarter 2018
|
Quarter |
Received |
Finalised |
Issued |
In progress |
Finalised within |
|---|---|---|---|---|---|
|
Sep 18 |
215 |
210 |
208 |
7 |
? 85% |
|
Total |
215 |
210 |
208 |
7 |
? 85% |
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.
7. Certificates of export
In the September quarter 2018, 149 certificates of export were issued.
7.1. Certificates of export—September quarter 2018
|
Quarter |
Received |
Issued |
Not issued |
In progress |
Finalised within |
|---|---|---|---|---|---|
|
Sep 18 |
158 |
149 |
3 |
8 |
? 65% |
|
Total |
158 |
149 |
3 |
8 |
? 65% |
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 is no statutory timeframe for consents to import—the APVMA seeks to process these within 20 days.