Analysis by type of application

Type of application

Previous WIP

Received

Processed

New WIP

Pre-application assistance

66

54

78

42

Product registration – pesticides

520

225

336

409

Product registration – veterinary medicines

249

213

222

240

Permits (exc emergency)

207

97

137

167

Emergency permits (Item 22)

8

13

18

3

Actives

190

39

60

169

Items 8L, 8M, 8P

16

46

58

4

Technical assessment (Item 25)

9

6

3

12

Notifiable variations

0

219

218

1

Import consents

33

107

138

2

Certificates of Export

40

85

93

31

Total

1 338

1 104

1 361

1 080

WIP = Work in process.

See description of application types.

1.1. Applications processed – December quarter 2021

Type

Previous WIP

Received

Processed

Processed on time (%)

New WIP

New WIP still on time (%)

Pesticides

520

225

336

99.4%

409

97.8%

Veterinary medicines

249

213

222

99.1%

240

98.3%

Subtotal (products)

769

438

558

99.3%

649

98.0%

Permits (exc emergency)

207

97

137

91.2%

167

92.2%

Emergency permits (Item 22)

8

13

18

N/A

3

N/A

Actives

190

39

60

100.0%

169

97.0%

Total

1 174

587

773

97.9%

988

96.9%

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.

Pre-application assistance – December quarter 2021

Type

Previous WIP

Received

Processed

Processed on time (%)

New WIP

Tier 1 (1 month)

11

44

13

76.9%

42

Tier 2 (2 month)

53

9

62

79.0%

0

Tier 3 (3 month)

2

1

3

66.7%

0

Total

66

54

78

78.2%

42

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 December quarter 2021, the APVMA issued 17 emergency permits, taking an average of 22 days, with a range of 3 to 82 days.

Emergency permits – December quarter 2021

 

Previous WIP

Received

Processed

Issued

Refused

Withdrawn or other

New WIP

Emergency permits (Item 22)

8

13

18

17

0

1

3

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

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

Assessment type

Previous WIP

Received

Processed

New WIP

Processed on time (%)

Technical assessment (Item 25)

9

6

3

12

100.0%

Items 8L, 8M, 8P

16

46

58

4

100.0%

Notifiable variations

0

219

218

1

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 – December quarter 2021

Application type

Previous WIP

Received

Processed

Issued

New WIP

Processed on time (%)

Import consents

33

107

138

138

2

97.1%

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 – December quarter 2021

Application Type

Previous WIP

Received

Processed

Issued

New WIP

Processed on time (%)

Certificate of Export

40

85

93

92

31

73%

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