1. Summary of activities related to regulatory decisions – September quarter 2022
|
Type of application |
Previous WIP |
Received |
Processed |
New WIP |
|---|---|---|---|---|
|
Pre-application assistance |
40 |
90 |
51 |
79 |
|
Product registration – pesticides |
467 |
298 |
268 |
497 |
|
Product registration – veterinary medicines |
299 |
407 |
381 |
325 |
|
Permits (exc emergency) |
195 |
108 |
136 |
167 |
|
Emergency permits (Item 22) |
1 |
22 |
19 |
4 |
|
Actives |
245 |
42 |
93 |
194 |
|
Items 8L, 8M, 8P |
0 |
110 |
24 |
86 |
|
Technical assessment (Item 25) |
14 |
4 |
3 |
15 |
|
Notifiable variations |
0 |
171 |
171 |
0 |
|
Import consents |
29 |
229 |
244 |
13 |
|
Certificate of Export |
69 |
160 |
183 |
46 |
|
Total |
1 359 |
1 641 |
1 573 |
1 426 |
WIP = Work in process
See description of application types.
Applications processed – September quarter 2022
|
Type |
Previous WIP |
Received |
Processed |
Processed on time (%) |
New WIP |
New WIP still on time (%) |
|---|---|---|---|---|---|---|
|
Pesticides |
467 |
298 |
268 |
94.4% |
497 |
95.8% |
|
Veterinary medicines |
299 |
407 |
381 |
99.5% |
325 |
98.8% |
|
Subtotal (products) |
766 |
705 |
649 |
97.4% |
822 |
97.0% |
|
Permits (exc emergency) |
195 |
108 |
136 |
94.9% |
167 |
94.6% |
|
Emergency permits (Item 22) |
1 |
22 |
19 |
N/A |
4 |
N/A |
|
Actives |
245 |
42 |
93 |
96.8% |
194 |
95.9% |
|
Total |
1 207 |
877 |
897 |
96.9% |
1 187 |
96.4% |
Note: Emergency permits (Item 22) do not have a numerical statutory timeframe. The APVMA must determine the application as soon as is practicable in the circumstances of the case (see Emergency permits).
2. Pre-application assistance
Pre-application assistance (PAA) is an optional, three-tiered, fee-based service for applicants to provide them with advice before they submit an application for registration. PAAs do not have a numerical statutory timeframe; the target timeframe for each tier is based on the anticipated complexity of the proposed application and effort required to provide the assistance.
|
Type |
Previous WIP |
Received |
Processed |
Processed on time (%) |
New WIP |
|---|---|---|---|---|---|
|
Tier 1 (1 month) |
14 |
84 |
22 |
68.2% |
76 |
|
Tier 2 (2 month) |
20 |
6 |
24 |
62.5% |
2 |
|
Tier 3 (3 month) |
6 |
0 |
5 |
20.0% |
1 |
|
Total |
40 |
90 |
51 |
60.8% |
79 |
3. Emergency permits
Emergency permits (Item 22) do not have a numerical statutory timeframe. The APVMA must determine the application as soon as is practicable in the circumstances of the case. In this reporting period, the APVMA issued 14 emergency permits, taking an average of 26 days, with a range of 8 to 73 days.
|
|
Previous WIP |
Received |
Processed |
Issued |
Refused |
Withdrawn or other |
New WIP |
|---|---|---|---|---|---|---|---|
|
Emergency permits (Item 22) |
1 |
22 |
19 |
17 |
0 |
2 |
4 |
4. Technical assessment, notifiable variations, holders and nominated agents
|
Assessment type |
Previous WIP |
Received |
Processed |
New WIP |
Processed on time (%) |
|---|---|---|---|---|---|
|
Technical assessment (Item 25) |
14 |
4 |
3 |
15 |
66.7% |
|
Items 8L, 8M, 8P |
0 |
110 |
24 |
86 |
100.0% |
|
Notifiable variations |
0 |
171 |
171 |
0 |
100.0% |
5. Consents to import
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.
|
Application type |
Previous WIP |
Received |
Processed |
Issued |
New WIP |
Processed on time (%) |
|---|---|---|---|---|---|---|
|
Import consents |
29 |
229 |
244 |
230 |
13 |
99.2% |
6. Certificates of Export
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 certificates of export – the APVMA seeks to process these within 20 days. Please note that an application may request multiple certificates.
|
|
Previous WIP |
Received |
Processed |
Issued |
New WIP |
Processed on time (%) |
|---|---|---|---|---|---|---|
|
Applications |
69 |
160 |
183 |
181 |
46 |
61.8% |
|
Certificates of Export |
271 |
741 |
941 |
939 |
71 |
66.1% |