Analysis by type of application

Types of regulatory decisions*

Commenced

Finalised/issued

In progress

Pre-application assistance

87

28

59

Product registration – pesticides

453

382

588

Product registration – veterinary medicines

363

391

244

Permits

117

167

239

Actives

71

76

182

Items 8L, 8M, 8P

444

431

45

Technical assessment (Item 25)

5

3

10

Notifiable variations

301

297

15

Import consents

239

187

27

Certificates of export

114

124

22

Total

2194

2086

1431

*See description of application types.

1.1. Applications processed – September quarter 2020

 

Commenced

Finalised

Finalised within timeframe

2019/20 in timeframe

In progress

In progress still within timeframe

Pesticides

453

382

98%

92%

588

99%

Veterinary medicines

363

391

98%

89%

244

96%

Total products

816

773

98%

91%

832

98%

Permits

117

167

79%

81%

239

68%

Actives

71

76

96%

85%

182

96%

Total

1004

1016

94%

88%

1253

92%

2. Pre-application assistance

In the September quarter 2020:

  • 87 applications were received
  • 28 applications were finalised
  • 59 applications were in progress at the end of the quarter.

2.1. Pre-application assistance – September quarter 2020

 

Received

Finalised

Within timeframe

In progress

Tier 1 (1 month)

17

10

9

7

Tier 2 (2 months)

62

16

13

46

Tier 3 (3 months)

8

2

2

6

Total

87

28

24

59

* This includes all PAAs received under the previous process.

Pre-Application Assistance (PAA) is an optional, three-tiered, fee-based service provided to 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.

3. Preliminary assessment

Preliminary assessment is a legislatively required administrative check of all applications to ensure the information necessary to proceed to a full evaluation is present. The timeframe for preliminary assessment is one month from lodgement.

In the September quarter 2020:

  • 598 were received
  • 772 were processed
  • 98% were completed within timeframe.

3.1. Preliminary assessment – September quarter 2020

Application Type

Received

Completed

Refused

Withdrawn

Within timeframe

Pesticides

342

453

0

5

99%

Veterinary medicines

93

127

0

2

94%

Total products

435

580

0

7

98%

Permits

110

117

0

4

100%

Actives

53

75

0

0

97%

Total

598

772

0

11

98%

4. Applications commenced

In the September quarter 2020, 1004 applications were commenced:

  • 816 for products
  • 117 for permits
  • 71 for actives.

Applications commenced - September quarter 2020

5. Applications finalised

In the September quarter 2020, 1016 applications were finalised:

  • 773 for products
  • 167 for permits
  • 76 for actives.

Applications finalised - September quarter 2020

6. Timeframe performance

In the September quarter 2020, timeframe performance results for applications were:

  • 98% for pesticide products
  • 98% for veterinary medicines products
  • 78% for permits
  • 96% for actives.

Timeframe performance - September quarter 2020

7. Work in progress

At the end of September quarter 2020, there were:

  • 1253 applications in progress:
    • 832 product applications
    • 239 permit applications
    • 182 active applications
  • 92% were within timeframe.

Work in progress - September quarter 2020

 

Work in progress within timeframe - September quarter 2020

Work in progress is an indicator of the current workload of the APVMA. It is calculated as the number of applications still in evaluation at the end of the quarter.

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

In the September quarter 2020:

  • 3 technical assessments on data packages were finalised
  • 431 applications to change (or create) a holder or nominated agent (Item 8L, 8M, 8P) were finalised
  • 297 minor changes to the details of a registered product, active or label (notifiable variations) were finalised.

8.1. Other regulatory assessments – September quarter 2020

Assessment type

Commenced

Finalised

In progress

Finalised within timeframe (%)

Technical assessment

5

3

10

68%

Items 8L, 8M, 8P

444

431

45

98%

Notifiable variations

301

297

15

100%

9. Consents to import

In the September quarter 2020, 128 consents to import were issued.

9.1. Consents to import – September quarter 2020

Quarter

Received

Finalised

Issued

In progress

Finalised within targeted time (%)

Sep 20

239

187

128

27

30

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.

10. Certificates of export

In the September quarter 2020, 124 certificates of export were issued.

10.1. Certificates of export – September quarter 2020

Quarter

Received

Issued

Not issued

In progress

Finalised within targeted time (%)

Sep 20

114

124

3

22

62%

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.

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