Analysis by type of application

Types of regulatory decisions*

Commenced

Finalised/issued

In progress

Pre-application assistance

51

48

45

Product registration—pesticides

279

353

444

Product registration—veterinary medicines

185

177

320

Permits

211

135

299

Actives

84

88

188

Items 8L, 8M, 8P

90

56

226

Technical assessment (Item 25)

3

1

8

Notifiable variations

293

259

34

Import consents

172

140

3

Certificates of export

86

64

30

Total

1454

1321

1597

*See description of application types.

1.1. Applications processed—March quarter 2020

?

Commenced

Finalised

Finalised within timeframe

2018/19 in timeframe

In progress

In progress still within timeframe

Pesticides

279

353

97%

85%

444

97%

Veterinary medicines

185

177

87%

81%

320

93%

Total products

464

530

94%

83%

764

95%

Permits

211

135

77%

84%

299

70%

Actives

84

88

89%

92%

188

91%

Total

759

753

90%

85%

1251

89%

2. Pre-Application Assistance

In the March quarter 2020:

  • 51 applications were received
  • 48 applications were finalised
  • 45 applications were in progress at the end of the quarter.

2.1. Pre-Application Assistance—March quarter 2020

?

Received

Finalised

Within timeframe

In progress

Tier 1 (1 month)

16

16

10

11

Tier 2 (2 months)

31

29

25

32

Tier 3 (3 months)

4

3

3

2

Total

51

48

38

45

* 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

In the March quarter 2020:

  • 636 were received
  • 674 were processed
  • 98 per cent were completed within the one month timeframe.

3.1. Preliminary assessment—March quarter 2020

Application type

Received

Completed

Refused

Withdrawn

Within timeframe

Pesticides

239

266

0

2

100%

Veterinary medicines

131

199

0

1

98%

Total products

370

385

0

3

99%

Permits

76

78

0

2

97%

Actives

76

78

0

0

97%

Total

636

674

0

5

98%

Preliminary assessment is a legislatively required administrative check of all applications received to ensure the information necessary to proceed to a full evaluation is present. The APVMA must complete a preliminary assessment of an application within one month after it is lodged.

4. Applications commenced

In the March quarter 2020, 759 applications were commenced:

  • 464 for products
  • 211 for permits
  • 84 for actives

March 2020 performance report, applications commenced

5. Applications finalised

In the March quarter 2020, 753 applications were finalised:

  • 530 for products
  • 135 for permits
  • 88 for actives.

March 2020 performance report, applications finalised

6. Timeframe performance

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

  • 97 per cent for pesticide products
  • 87 per cent for veterinary medicines products
  • 77 per cent for permits
  • 89 per cent for actives.

March 2020 performance report, timeframe performance

7. Work in progress

At the end of March quarter 2020, there were:

  • 1251 applications in progress:
    • 764 product applications
    • 299 permit applications
    • 188 active applications
  • 89 per cent were within timeframe.

March 2020 performance report, work in progress

?

March 2020 performance report, work in progress

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 March quarter 2020:

  • one technical assessment on data packages was finalised
  • 56 applications to change (or create) a holder or nominated agent (item 8L, 8M, 8P) were finalised
  • 259 minor changes to the details of a registered product, active or label (notifiable variations) were finalised.

8.1. Other regulatory assessments—March quarter 2020

Assessment type

Commenced

Finalised

In progress

Finalised within timeframe (%)

Technical assessment

3

1

8

100%

Items 8L, 8M, 8P

90

56

226

71%

Notifiable variations

293

259

34

100%

9. Consents to import

In the March quarter 2020, 140 consents to import were issued.

Quarter

Received

Finalised

Issued

In progress

Finalised within
targeted time (%)

Sep 19

187

178

163

0

92%

Dec 19

113

105

75

0

72%

Mar 20

172

179

140

3

78%

Total

472

432

378

3

82%

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 March quarter 2020, 64 certificates of export were issued.

Quarter

Received

Issued

Not issued

In progress

Finalised within
targeted time (%)

Sep 19

130

149

1

17

35%

Dec 19

66

72

0

11

82%

Mar 20

86

64

0

30

51%

Total

282

285

1

30

50%

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 consents to import—the APVMA seeks to process these within 20 days.

To protect your privacy, please do not include contact information in your feedback. If you would like a response, please contact us.