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Analysis by type of application
- 1. Summary of activities related to regulatory decisions—March quarter 2017 types
- 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—March quarter 2017 types
|
Types of regulatory decisions* |
Commenced |
Finalised/issued |
In progress |
|---|---|---|---|
|
Pre-application assistance |
39 |
32 |
39 |
|
Product registration—pesticides |
286 |
184 |
627 |
|
Product registration—veterinary medicines |
155 |
141 |
365 |
|
Actives |
161 |
205 |
234 |
|
Permits |
106 |
98 |
180 |
|
Items 8L, 8M, 8P |
69 |
65 |
18 |
|
Technical assessment (Item 25) |
4 |
7 |
14 |
|
Notifiable variations |
215 |
263 |
49 |
|
Import consents |
178 |
145 |
0 |
|
Certificates of export |
99 |
93 |
19 |
|
Total |
1312 |
1233 |
1545 |
*See description of application types.
2. Pre-application assistance
In March quarter 2017:
- 39 applications were received
- 32 applications were finalised
- 39 applications were in progress at the end of the quarter.
2.1. Pre-application assistance—March Quarter 2017
|
? |
Received |
Finalised |
Within timeframe |
In progress |
|---|---|---|---|---|
|
Tier 1 (1 month) |
15 |
14 |
3 |
9 |
|
Tier 2 (2 months) |
22 |
15 |
5 |
26 |
|
Tier 3 (3 months) |
0 |
3 |
1 |
3 |
|
Pre November 2015* |
0 |
0 |
0 |
1 |
|
Total |
39 |
32 |
9 |
39 |
* 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 tiers is based on the complexity and effort required to provide the assistance.
3. Preliminary assessment
In March quarter 2017:
- 99 per cent were completed within the 30 day timeframe
- 564 were received
- 654 were processed
- 97 per cent went into evaluation.
3.1. Preliminary assessment—March quarter 2017
|
Application Type |
Received |
Completed |
Refused |
Withdrawn |
Within timeframe |
|---|---|---|---|---|---|
|
Pesticides |
294 |
286 |
2 |
2 |
100% |
|
Veterinary medicines |
137 |
116 |
0 |
1 |
96% |
|
Total Products |
431 |
402 |
2(0.5%) |
3(0.7%) |
99% |
|
Permits |
144 |
108 |
0 |
0 |
100% |
|
Actives |
159 |
163 |
0 |
0 |
100% |
|
Total |
734 |
673 |
2(0.3%) |
3(0.4%) |
99% |
Preliminary assessment?is an administrative check of all applications received to ensure the information necessary to proceed to a full evaluation is present.? The timeframe for preliminary assessment 30 days from receipt.
4. Applications commenced
In March quarter 2017, 708 applications were commenced
- 441 for products
- 161 for actives
- 106 for permits
5. Applications finalised
In March quarter 2017, 628 applications were finalised
- 325 for products
- 205 for actives
- 98 for permits.
6. Timeframe performance
In March quarter 2017, timeframe performance results product applications were:
- 30 per cent for pesticide products
- 58 per cent for veterinary medicines products
- 95 per cent for actives
- 62 per cent for permits
7. Work in progress
At the end of March quarter 2017, there were:
- 1406 applications in progress
- 992 product applications
- 234 active applications
- 180 permit applications
- 73 per cent were within timeframe
?
Work in progress is an indicator of the future 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 March quarter 2017:
- 7 technical assessments on data packages were finalised
- 65 applications to change (or create) a holder or nominated agent?(item 8L, 8M, 8P) were finalised
- 263 minor changes to the details of a registered product, active or label (notifiable variations) were finalised.
8.1. Other regulatory assessments—March Quarter 2017
|
Assessment type |
Commenced |
Finalised |
In progress |
Finalised within timeframe (%) |
|---|---|---|---|---|
|
Technical assessment |
4 |
7 |
14 |
57% |
|
Items 8L, 8M, 8P |
69 |
65 |
18 |
66% |
|
Notifiable variations |
215 |
263 |
49 |
100% |
9. Consents to import
In March quarter 2017, 145 consents to import were issued.
9.1. Import consents—March Quarter 2017
|
Quarter |
Received |
Finalised |
Issued |
In progress |
Finalised within timeframe (%) |
|---|---|---|---|---|---|
|
Sep 16 |
148 |
141 |
132 |
17 |
92% |
|
Dec 16 |
112 |
115 |
107 |
0 |
96% |
|
Mar 17 |
178 |
147 |
145 |
0 |
? |
|
Total |
438 |
403 |
384 (95%) |
0 |
93% |
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 March quarter 2017, 93 certificates of export were issued.
10.1. Export certificates—March Quarter 2017
|
Quarter |
Received |
Issued |
Not Issued |
In progress |
Finalised within timeframe (%) |
|---|---|---|---|---|---|
|
Sep 16 |
72 |
72 |
0 |
3 |
69% |
|
Dec 16 |
96 |
95 |
0 |
10 |
87% |
|
Mar 17 |
99 |
93 |
1 |
19 |
71% |
|
Total |
267 |
260 |
1 |
19 |
76% |
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 try to complete them within 20 working days