1. Summary of activities related to regulatory decisions – March quarter 2022
|
Type of application |
Previous WIP |
Received |
Processed |
New WIP |
|---|---|---|---|---|
|
Pre-application assistance |
42 |
38 |
45 |
35 |
|
Product registration – pesticides |
416 |
196 |
228 |
384 |
|
Product registration – veterinary medicines |
243 |
236 |
181 |
298 |
|
Permits (exc emergency) |
169 |
126 |
102 |
193 |
|
Emergency permits (Item 22) |
3 |
18 |
13 |
8 |
|
Actives |
199 |
81 |
69 |
211 |
|
Items 8L, 8M, 8P |
4 |
49 |
50 |
3 |
|
Technical assessment (Item 25) |
12 |
3 |
2 |
13 |
|
Notifiable variations |
0 |
167 |
167 |
0 |
|
Import consents |
2 |
253 |
239 |
16 |
|
Certificate of Export |
31 |
63 |
58 |
36 |
|
Total |
1 121 |
1 230 |
1 154 |
1 197 |
WIP = Work in process
See description of application types.
Applications processed – March quarter 2022
|
Type |
Previous WIP |
Received |
Processed |
Processed on time (%) |
New WIP |
New WIP still on time (%) |
|---|---|---|---|---|---|---|
|
Pesticides |
416 |
196 |
228 |
98.2% |
384 |
98.4% |
|
Veterinary medicines |
243 |
236 |
181 |
100.0% |
298 |
98.0% |
|
Subtotal (products) |
659 |
432 |
409 |
99.0% |
682 |
98.2% |
|
Permits (exc emergency) |
169 |
126 |
102 |
92.2% |
193 |
93.3% |
|
Emergency permits (Item 22) |
3 |
18 |
13 |
N/A |
8 |
N/A |
|
Actives |
199 |
81 |
69 |
97.1% |
211 |
96.7% |
|
Total |
1 030 |
657 |
593 |
97.6% |
1 094 |
97.1% |
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) |
9 |
30 |
12 |
50.0% |
27 |
|
Tier 2 (2 month) |
30 |
7 |
31 |
45.2% |
6 |
|
Tier 3 (3 month) |
3 |
1 |
2 |
0.0% |
2 |
|
Total |
42 |
38 |
45 |
44.4% |
35 |
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 9 emergency permits, taking an average of 14 days, with a range of 2 to 29 days.
|
|
Previous WIP |
Received |
Processed |
Issued |
Refused |
Withdrawn or other |
New WIP |
|---|---|---|---|---|---|---|---|
|
Emergency permits (Item 22) |
3 |
18 |
13 |
9 |
1 |
3 |
8 |
4. Technical assessment, notifiable variations, holders and nominated agents
|
Assessment type |
Previous WIP |
Received |
Processed |
New WIP |
Processed on time (%) |
|---|---|---|---|---|---|
|
Technical assessment (Item 25) |
12 |
3 |
2 |
13 |
100.0% |
|
Items 8L, 8M, 8P |
4 |
49 |
50 |
3 |
96.0% |
|
Notifiable variations |
0 |
167 |
167 |
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 |
2 |
253 |
239 |
231 |
16 |
97.9% |
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 |
31 |
63 |
58 |
58 |
36 |
93.1% |
|
Certificates of Export |
100 |
184 |
212 |
212 |
72 |
96.4% |