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Analysis by type of application
- 1. Summary of activities related to regulatory decisions—September?quarter?2017
- 2. Pre-application assistance
- 3. Preliminary assessment
- 4. Applications commenced
- 5. Applications finalised
- 6. Timeframe performance
- 7. Work in progress
- 8. Technical assessment, notifiable variations, holders and nominated agents
- 9. Consents to import
- 10. Certificates of export
1. Summary of activities related to regulatory decisions—September?quarter?2017
|
Types of regulatory decisions* |
Commenced |
Finalised/issued |
In progress |
|---|---|---|---|
|
Pre-application assistance |
27 |
30 |
35 |
|
Product registration—pesticides |
275 |
403 |
542 |
|
Product registration—veterinary medicines |
224 |
310 |
301 |
|
Actives |
103 |
177 |
299 |
|
Permits |
102 |
168 |
161 |
|
Items 8L, 8M, 8P |
230 |
241 |
6 |
|
Technical assessment (Item 25) |
5 |
5 |
14 |
|
Notifiable variations |
216 |
124 |
160 |
|
Import consents |
194 |
182 |
28 |
|
Certificates of export |
122 |
94 |
28 |
|
Total |
1498 |
1734 |
1574 |
*See description of?application types.
1.1. Applications processed—September quarter 2017
|
? |
Commenced |
Finalised |
Finalised Within Timeframe |
2016/17 in timeframe |
In Progress |
In progress still within timeframe |
|---|---|---|---|---|---|---|
|
Pesticides |
275 |
403 |
36% |
45% |
542 |
73% |
|
Veterinary medicines |
224 |
310 |
76% |
77% |
301 |
68% |
|
Total Products |
499 |
713 |
53% |
59% |
843 |
71% |
|
Actives |
103 |
177 |
82% |
88% |
299 |
85% |
|
Permits |
102 |
168 |
52% |
71% |
161 |
70% |
|
Total |
704 |
1058 |
58% |
69% |
1303 |
74% |
2. Pre-application assistance
In the September quarter 2017:
- 27 applications were received
- 30 applications were finalised
- 35 applications were in progress at the end of the quarter.
2.1. Pre-application assistance—September quarter 2017
|
? |
Received |
Finalised |
Within timeframe |
In progress |
|---|---|---|---|---|
|
Tier 1 (1 month) |
11 |
10 |
2 |
10 |
|
Tier 2 (2 months) |
15 |
16 |
3 |
23 |
|
Tier 3 (3 months) |
1 |
4 |
2 |
2 |
|
Total |
27 |
30 |
7 |
35 |
* 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 2017:
- 622 were received
- 604 were processed
- 99 per cent were completed within the one month timeframe
3.1. Preliminary assessment—September quarter 2017
|
Application Type |
Received |
Completed |
Refused |
Withdrawn |
Within timeframe |
|---|---|---|---|---|---|
|
Pesticides |
302 |
295 |
3 |
0 |
98% |
|
Veterinary medicines |
117 |
101 |
0 |
0 |
100% |
|
Total Products |
419 |
396 |
3(0.7%) |
0(0%) |
98% |
|
Permits |
118 |
104 |
3 |
0 |
100% |
|
Actives |
85 |
104 |
0 |
1 |
100% |
|
Total |
622 |
604 |
6(1%) |
1(0.1%) |
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 2017, 704 applications were commenced
- 499 for products
- 103 for actives
- 102 for permits
5. Applications finalised
In the September quarter 2017, 1058 applications were finalised
- 713 for products
- 177 for actives
- 168 for permits
6. Timeframe performance
In the September quarter 2017, timeframe performance results for applications were:
- 36 per cent for pesticide products
- 76 per cent for veterinary medicines products
- 82 per cent for actives
- 52 per cent for permits
7. Work in progress
At the end of September quarter 2017, there were:
- 1303 applications in progress
- 843 product applications
- 299 active applications
- 161 permit applications
- 74 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.
8. Technical assessment, notifiable variations, holders and nominated agents
In the September quarter 2017:
- 5 technical assessments on data packages were finalised
- 241 applications to change (or create) a holder or nominated agent?(item 8L, 8M, 8P) were finalised
- 124 minor changes to the details of a registered product, active or label (notifiable variations) were finalised.
8.1. Other regulatory assessments—September quarter 2017
|
Assessment type |
Commenced |
Finalised |
In progress |
Finalised within timeframe (%) |
|---|---|---|---|---|
|
Technical assessment |
5 |
5 |
14 |
40% |
|
Items 8L, 8M, 8P |
230 |
241 |
6 |
91% |
|
Notifiable variations |
216 |
124 |
160 |
100% |
9. Consents to import
In the September quarter 2017, 177 consents to import were issued.
9.1. Import consents—September quarter 2017
|
Quarter |
Received |
Finalised |
Issued |
In progress |
Finalised within |
|---|---|---|---|---|---|
|
Sep 17 |
194 |
182 |
177 |
28 |
94% |
|
Total |
194 |
182 |
177 (97%) |
28 |
94% |
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.
10. Certificates of export
In the September quarter 2017, 94 certificates of export were issued.
10.1. Export certificates—September quarter 2017
|
Quarter |
Received |
Issued |
Not Issued |
In progress |
Finalised within |
|---|---|---|---|---|---|
|
Sep 17 |
122 |
94 |
0 |
28 |
80% |
|
Total |
122 |
94 |
0 |
28 |
80% |
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.
?