Analysis by type of application

Types of regulatory decisions*

Commenced

Finalised/issued

In progress

Pre-application assistance

42

33

40

Product registration—pesticides

208

264

417

Product registration—veterinary medicines

296

271

324

Actives

423

162

573

Permits

125

135

143

Items 8L, 8M, 8P

24

46

7

Technical assessment (Item 25)

1

1

11

Notifiable variations

235

196

39

Import consents

227

233

29

Certificates of export

101

110

9

Total

1682

1451

1592

*See description of application types.

1.1. Applications processed—March quarter 2018

 

Commenced

Finalised

Finalised Within Timeframe

2016/17 in timeframe

In Progress

In progress still within timeframe

Pesticides

208

264

76%

45%

417

80%

Veterinary medicines

296

271

88%

77%

324

76%

Total Products

504

535

82%

59%

741

78%

Permits

125

135

65%

88%

143

85%

Actives

423

162

82%

71%

573

94%

Total

1052

832

79%

69%

1457

85%

2. Pre-application assistance

In the March quarter 2018:

  • 42 applications were received
  • 33 applications were finalised
  • 40 applications were in progress at the end of the quarter.

2.1. Pre-application assistance—March quarter 2018

 

Received

Finalised

Within timeframe

In progress

Tier 1 (1 month)

15

12

5

10

Tier 2 (2 months)

26

20

6

27

Tier 3 (3 months)

1

1

0

3

Total

42

33

11

40

* 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 2018:

  • 845 were received
  • 851 were processed
  • 99 per cent were completed within the 30-day timeframe

3.1. Preliminary assessment—March quarter 2018

Application Type

Received

Completed

Refused

Withdrawn

Within timeframe

Pesticides

244

208

1

0

99%

Veterinary medicines

110

95

3

4

100

Total Products

354

303

4

4

99%

Permits

133

127

0

2

97%

Actives

358

421

0

1

100%

Total

845

851

4

7

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 March quarter 2018, 1052 applications were commenced

  • 504 for products
  • 423 for actives
  • 125 for permits

5. Applications finalised

In the March quarter 2018, 832 applications were finalised

  • 535 for products
  • 162 for actives
  • 135 for permits

6. Timeframe performance

In the March quarter 2018, timeframe performance results for applications were:

  • 76 per cent for pesticide products
  • 88 per cent for veterinary medicines products
  • 82 per cent for actives
  • 65 per cent for permits

7. Work in progress

At the end of March quarter 2018, there were:

  • 1457 applications in progress
  • 741 product applications
  • 573 active applications
  • 143 permit applications
  • 85 per cent were within timeframe

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 2018:

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

8.1. Other regulatory assessments—March quarter 2018

Assessment type

Commenced

Finalised

In progress

Finalised within timeframe (%)

Technical assessment

1

1

11

0%

Items 8L, 8M, 8P

24

46

7

57%

Notifiable variations

235

196

39

100%

Consents to import

In the March quarter 2018, 602 consents to import were issued.

8.2. Consents to import—March quarter 2018

Quarter

Received

Finalised

Issued

In progress

Finalised within
targeted time (%)

Sep 17

194

182

177

28

94%

Dec 17

160

199

194

34

12%

Mar 18

227

233

231

29

65%

Total

581

614

602

29

56%

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.

9. Certificates of export

In the March quarter 2018, 110 certificates of export were issued.

9.1. Certificates of export—March quarter 2018

Quarter

Received

Issued

Not Issued

In progress

Finalised within
targeted time (%)

Sep 17

122

94

0

28

80%

Dec 17

61

58

1

19

25%

Mar 18

101

110

0

9

69%

Total

284

262

1

9

52%

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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