Analysis by type of application

Type of application

Previous WIP

Received

Processed

New WIP

Pre-application assistance

39

85

58

66

Product registration – pesticides

432

349

261

520

Product registration – veterinary medicines

248

271

270

249

Permits (excluding emergency)

253

121

167

207

Emergency permits (Item 22)

7

22

21

8

Actives

166

76

52

190

Items 8L, 8M, 8P

210

155

349

16

Technical assessment (Item 25)

10

6

7

9

Notifiable variations

1

345

346

0

Import Consents

5

193

165

33

Certificate of exports

20

151

131

40

Total

1 391

1 774

1 827

1 338

WIP = Work in process.

See description of application types.

1.1. Applications processed – September quarter 2021

Type

Previous WIP

Received

Processed

Processed on time (%)

New WIP

New WIP still on time (%)

Pesticides

432

349

261

98.9%

520

98.7%

Veterinary medicines

248

271

270

99.3%

249

97.6%

Subtotal (products)

680

620

531

99.1%

769

98.3%

Permits (excluding emergency)

253

121

167

80.2%

207

90.3%

Emergency permits (Item 22)

7

22

21

N/A

8

N/A

Actives

166

76

52

96.2%

190

97.9%

Total

1 106

839

771

94.7%

1 174

96.8%

Please note that 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. The timeframe for each tier is based on the complexity of the proposed application and effort required to provide the assistance.

Pre-application assistance – September quarter 2021

Type

Previous WIP

Received

Processed

Processed on time (%)

New WIP

Tier 1 (1 month)

7

21

15

80.0%

13

Tier 2 (2 month)

27

63

38

52.6%

52

Tier 3 (3 month)

5

1

5

40.0%

1

Total

39

85

58

58.6%

66

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 the September quarter 2021, the APVMA issued 16 emergency permits, taking an average of 33 days, with a range of 13 to 146 days.

Emergency permits – September quarter 2021

 

Previous WIP

Received

Processed

Issued

Refused

Withdrawn or other

New WIP

Emergency permits (Item 22)

7

22

21

16

3

2

8

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

Technical assessment, notifiable variations, holders and nominated agents – September quarter 2021

Assessment type

Previous WIP

Received

Processed

New WIP

Processed on time (%)

Technical assessment (Item 25)

10

6

7

9

100.0%

Items 8L, 8M, 8P

210

155

349

16

94.8%

Notifiable variations

1

345

346

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.

Consents to import – September quarter 2021

Application type

Previous WIP

Received

Processed

Issued

New WIP

Processed on time (%)

Consent to Import

5

193

165

161

33

98%

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.

Certificates of Export – September quarter 2021

Application type

Previous WIP

Received

Processed

Issued

New WIP

Processed on time (%)

Certificates of Export

20

151

131

131

40

93%

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