Analysis by type of application

Types of regulatory decisions*

Commenced

Finalised/issued

In progress

Pre-application assistance

52

35

17

Product registration – pesticides

341

459

472

Product registration – veterinary medicines

324

348

221

Permits

150

137

253

Actives

69

75

175

Items 8L, 8M, 8P

63

73

35

Technical assessment (Item 25)

1

2

9

Notifiable variations

309

306

14

Import consents

105

107

17

Certificates of export

102

110

12

Total

1516

1652

1225

*See description of application types

1.1. Applications processed – December quarter 2020

 

Commenced

Finalised

Finalised within timeframe

2019/20 in timeframe

In progress

In progress still within timeframe

Pesticides

341

459

99%

92%

472

99%

Veterinary medicines

324

348

99%

89%

221

96%

Total products

665

807

99%

91%

693

98%

Permits

150

137

75%

81%

253

67%

Actives

69

75

100%

85%

175

94%

Total

884

1019

96%

88%

1121

91%

2. Pre-application assistance

In the December quarter 2020:

  • 52 applications were received
  • 35 applications were finalised
  • 17 applications were in progress at the end of the quarter.

2.1. Pre-application assistance – December quarter 2020

 

Received

Finalised

Within timeframe

In progress

Tier 1 (1 month)

17

16

12

1

Tier 2 (2 months)

29

16

13

13

Tier 3 (3 months)

6

3

2

3

Total

52

35

27

17

* 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 December quarter 2020:

  • 689 were received
  • 697 were processed
  • 99% were completed within timeframe.

3.1. Preliminary assessment– December quarter 2020

Application type

Received

Completed

Refused

Withdrawn

Within timeframe

Pesticides

329

337

0

0

100%

Veterinary medicines

128

133

1

7

97%

Total products

457

470

1

7

99%

Permits

155

156

1

6

99%

Actives

77

71

0

0

100%

Total

689

697

2

13

99%

4. Applications commenced

In the December quarter 2020, 884 applications were commenced.

  • 665 for products
  • 150 for permits
  • 69 for actives

Applications commenced in December quarter 2020

5. Applications finalised

In the December quarter 2020, 1019 applications were finalised.

  • 807 for products
  • 137 for permits
  • 75 for actives

Applications finalised, December quarter 2020

6. Timeframe performance

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

  • 99% for pesticide products
  • 99% for veterinary medicines products
  • 75% for permits
  • 100% for actives.

Timeframe performance, December quarter 2020

7. Work in progress

At the end of December quarter 2020, there were:

  • 1,121 applications in progress:
    • 693 product applications
    • 253 permit applications
    • 175 active applications.
  • 91% were within timeframe.

Work in progress within timeframe, December 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 December quarter 2020:

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

8.1. Other regulatory assessments – December quarter 2020

Assessment type

Commenced

Finalised

In progress

Finalised within timeframe (%)

Technical assessment

1

2

9

100%

Items 8L, 8M, 8P

63

76

35

77%

Notifiable variations

309

306

14

100%

9. Consents to import

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

9.1. Consents to import – December quarter 2020

Quarter

Received

Finalised

Issued

In progress

Finalised within targeted time (%)

Sep 20

239

187

128

27

30%

Dec 20

105

109

107

17

84%

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 December quarter 2020, 110 certificates of export were issued.

10.1. Certificates of export – December quarter 2020

Quarter

Received

Issued

Not issued

In progress

Finalised within targeted time (%)

Sep 20

114

124

3

22

62%

Dec 20

102

110

0

12

90%

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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