Analysis by type of application

Types of regulatory decisions*

Commenced

Finalised/issued

In progress

Pre-application assistance

163

248

39

Product registration—pesticides

651

581

521

Product registration—veterinary medicines

403

394

311

Permits

242

267

224

Actives

150

160

191

Items 8L, 8M, 8P

454

309

192

Technical assessment (Item 25)

5

7

6

Notifiable variations

549

523

27

Import consents

300

283

0

Certificates of export

196

221

11

Total

3113

2993

1522

*See description of application types.

1.1. Applications processed 1 July–31 December 2019

 

Quarter 1

(Jul–Sep 2019)

Quarter 2

(Oct–Dec 2019)

2018–19 in timeframe

In progress

In progress still within timeframe

Commenced

Finalised

Finalised within timeframe

Commenced

Finalised

Finalised within timeframe

Pesticides

311

263

83%

340

319

92%

85%

521

96%

Veterinary medicines

232

207

87%

171

187

82%

81%

311

87%

Total Products

543

470

85%

511

506

88%

83%

832

92%

Permits

146

153

85%

96

114

85%

84%

224

76%

Actives

73

56

82%

77

104

80%

92%

191

90%

Total

762

679

85%

684

724

87%

85%

1247

89%

2. Pre-application assistance

Between 1 July and 31 December 2019:

  • 163 applications were received
  • 248 applications were finalised
  • 39 applications were in progress at the end of the quarter.

2.1. Pre-application assistance—1 July to 31 December 2019

 

Received

Finalised

Within timeframe

In progress

Tier 1 (1 month)

33

32

20

21

Tier 2 (2 months)

121

203

73

22

Tier 3 (3 months)

9

13

7

4

Total

163

248

100

39

* 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

Between 1 July and 31 December 2019:

  • 1330 were received
  • 1306 were processed
  • 99 per cent were completed within the 30-day timeframe.

3.1. Preliminary assessment—1 July to 31 December 2019

Application Type

Received

Completed

Refused

Withdrawn

Within timeframe

Pesticides

650

633

0

7

99%

Veterinary medicines

277

279

0

2

99%

Total Products

927

912

0

9

99%

Permits

261

244

0

1

98%

Actives

142

150

0

1

100%

Total

1330

1306

0

11

99%

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 timeframe for preliminary assessment is 30 days from receipt.

4. Applications commenced

In the December quarter 2019, the APVMA commenced 684 applications.

  • 511 for products
  • 96 for permits
  • 77 for actives.

Applications commenced, 1 July to 31 December 2019 performance statistics

5. Applications finalised

In the December quarter 2019, the APVMA finalised 724 applications.

  • 506 for products
  • 114 for permits
  • 104 for actives.

Applications finalised, 1 July to 31 December 2019 performance statistics

6. Timeframe performance

In the December quarter 2019, timeframe performance results for applications were:

  • 92 per cent for pesticide products
  • 82 per cent for veterinary medicines products
  • 85 per cent for permits
  • 80 per cent for actives.

Timeframe performance 1 July to 31 December 2019 performance statistics

7. Work in progress

At the end of December 2019, there were:

  • 1247 applications in progress
    • 832 product applications
    • 224 permit applications
    • 191 active applications
  • 89 per cent were within timeframe.

Work in progress 1 July to 31 December 2019 performance statistics

Work in progress within timeframe 1 July to 31 December 2019 performance statistics

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

Between 1 July and 31 December 2019:

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

8.1. Other regulatory assessments—1 July to 31 December 2019

Assessment type

Commenced

Finalised

In progress

Finalised within timeframe (%)

Technical assessment

5

7

6

43%

Items 8L, 8M, 8P

454

309

192

94%

Notifiable variations

549

523

27

100%

9. Consents to import

Between 1 July and 31 December 2019, the APVMA issued 238 consents to import.

9.1. Consents to import—1 July to 31 December 2019

Quarter

Received

Finalised

Issued

In progress

Finalised within targeted time (%)

Sep 19

187

178

163

0

  92%

Dec 19

113

105

75

0

  72%

Total

300

283

238

0

  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

Between 1 July and 31 December 2019, the APVMA issued 221 certificates of export.

10.1. Certificates of export—1 July to 31 December 2019

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%

Total

196

221

1

11

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.

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