Analysis by type of application

Type of application

Previous WIP

Received

Processed

New WIP

Pre-application assistance

35

44

39

40

Product registration – pesticides

383

263

180

466

Product registration – veterinary medicines

300

186

195

291

Permits (exc emergency)

193

138

136

195

Emergency permits (Item 22)

8

12

18

2

Actives

213

81

55

239

Items 8L, 8M, 8P

3

92

95

0

Technical assessment (Item 25)

13

5

4

14

Notifiable variations

0

177

170

7

Import consents

16

165

153

29

Certificate of Export

36

95

63

68

Total

1 200

1 258

1 108

1 351

WIP = Work in process

See description of application types.

Applications processed – June quarter 2022

Type

Previous WIP

Received

Processed

Processed on time (%)

New WIP

New WIP still on time (%)

Pesticides

383

263

180

98.9%

466

95.9%

Veterinary medicines

300

186

195

100.0%

291

97.9%

Subtotal (products)

683

449

375

99.5%

757

96.7%

Permits (exc emergency)

193

138

136

92.6%

195

93.8%

Emergency permits (Item 22)

8

12

18

N/A

2

N/A

Actives

213

81

55

100.0%

239

95.4%

Total

1 097

680

584

97.9%

1 193

96.0%

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)

12

36

8

50.0%

40

Tier 2 (2 month)

20

6

26

30.8%

0

Tier 3 (3 month)

3

2

5

100.0%

0

Total

35

44

39

43.6%

40

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Withdrawn or other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)

8

12

18

14

1

3

2

4. Technical assessment, notifiable variations, holders and nominated agents

Assessment Type

Previous WIP

Received

Processed

New WIP

Processed on time (%)

Technical assessment (Item 25)

13

5

4

14

100.0%

Items 8L, 8M, 8P

3

92

95

0

100.0%

Notifiable variations

0

177

170

7

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

16

165

153

143

29

100.0%

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%

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