Analysis by type of application

Types of regulatory decisions*

Commenced

Finalised/issued

In progress

Pre-application assistance

57

61

34

Product registration—pesticides

349

271

522

Product registration—veterinary medicines

227

249

268

Permits

175

179

289

Actives

67

69

186

Items 8L, 8M, 8P

192

396

32

Technical assessment (Item 25)

2

2

8

Notifiable variations

321

308

24

Import consents

125

122

0

Certificates of export

58

56

27

Total

1573

1713

1390

*See description of application types.

1.1. Applications processed—June quarter 2020

 

Commenced

Finalised

Finalised within timeframe

2018/19 in timeframe

In progress

In progress still within timeframe

Pesticides

349

271

94%

85%

522

98%

Veterinary medicines

227

249

95%

81%

268

94%

Total Products

576

520

95%

83%

790

97%

Permits

175

179

77%

84%

289

70%

Actives

67

69

93%

92%

186

93%

Total

818

768

90%

85%

1265

90%

2. Pre-application assistance

In the June quarter 2020:

  • 57 applications were received
  • 61 applications were finalised
  • 34 applications were in progress at the end of the quarter.

2.1. Pre-application assistance—June quarter 2020

 

Received

Finalised

Within timeframe

In progress

Tier 1 (1 month)

15

18

10

7

Tier 2 (2 months)

39

37

23

24

Tier 3 (3 months)

3

6

4

3

Total

57

61

37

34

* 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 June quarter 2020:

  • 879 were received
  • 757 were processed
  • 98 per cent were completed within timeframe.

3.1. Preliminary assessment—June quarter 2020

Application Type

Received

Completed

Refused

Withdrawn

Within timeframe

Pesticides

453

366

0

1

98%

Veterinary medicines

160

144

0

1

96%

Total Products

613

510

0

2

98%

Permits

176

179

0

5

100%

Actives

90

68

0

0

98%

Total

879

757

0

7

98%

4. Applications commenced

In the June quarter 2020, 818 applications were commenced:

  • 576 for products
  • 175 for permits
  • 67 for actives.

APVMA applications commenced, June quarter 2020

5. Applications finalised

In the June quarter 2020, 768 applications were finalised:

  • 520 for products
  • 179 for permits
  • 69 for actives.

APVMA applications finalised, June quarter 2020

6. Timeframe performance

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

  • 94 per cent for pesticide products
  • 95 per cent for veterinary medicines products
  • 77 per cent for permits
  • 93 per cent for actives.

APVMA timeframe performance, June quarter 2020

7. Work in progress

At the end of June quarter 2020, there were:

  • 1265 applications in progress:
    • 790 product applications
    • 289 permit applications
    • 186 active applications
  • 90 per cent were within timeframe.

APVMA work in progress, June quarter 2020

APVMA work in progress within timeframe, June 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 June quarter 2020:

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

8.1. Other regulatory assessments—June quarter 2020

Assessment type

Commenced

Finalised

In progress

Finalised within timeframe (%)

Technical assessment

2

2

8

100%

Items 8L, 8M, 8P

192

396

32

52%

Notifiable variations

321

308

24

100%

9. Consents to import

In the June quarter 2020, 122 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%

Jun 20

125

122

84

0

  69%

Total

597

584

462

0

  79%

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 June 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%

Jun 20

58

56

7

27

84%

Total

340

341

8

27

56%

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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