Analysis by type of application

Types of regulatory decisions*

Commenced

Finalised/issued

In progress

Pre-application assistance

42

41

28

Product registration—pesticides

335 

260  496

Product registration—veterinary medicines

216 

251 288

Actives

54 

267 357

Permits

133

111 165

Items 8L, 8M, 8P

236

212 36

Technical assessment (Item 25)

2

8 5

Notifiable variations

141

126 15

Import consents

159

165 14

Certificates of export

51

47 6

Total

1369  

1488 1410

*See description of application types.

1.1. Applications processed—June quarter 2018

 

Commenced

Finalised

Finalised Within Timeframe

2016/17 in timeframe

In Progress

In progress still within timeframe

Pesticides

335

260

77%

45%

496

85%

Veterinary medicines

216

251

84%

77%

288

68%

Total Products

551

511

80%

59%

784

79%

Permits

133

111

80%

71%

165

88%

Actives

54

267

95%

88%

357

92%

Total

738

889

85%

69%

1306

83%

2. Pre-application assistance

In the June quarter 2018:

  • 42 applications were received
  • 41 applications were finalised
  • 28 applications were in progress at the end of the quarter.

2.1. Pre-application assistance—June quarter 2018

 

Received

Finalised

Within timeframe

In progress

Tier 1 (1 month)

18

14

6

10

Tier 2 (2 months)

23

26

8

17

Tier 3 (3 months)

1

1

1

1

Total

42

41

15

28

* 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 June quarter 2018:

  • 734 were received
  • 636 were processed
  • 99 per cent were completed within the 30-day timeframe

3.1. Preliminary assessment—June quarter 2018

Application Type

Received

Completed

Refused

Withdrawn

Within timeframe

Pesticides

373

334

0

3

99%

Veterinary medicines

144

116

0

0

100

Total Products

517

450

0

3

99%

Permits

159

131

5

2

100%

Actives

58

55

0

0

100%

Total

734

636

5

5

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 June quarter 2018, 738 applications were commenced

  • 551 for products
  • 54 for actives
  • 133 for permits

5. Applications finalised

In the June quarter 2018, 889 applications were finalised

  • 510 for products
  • 267 for actives
  • 111 for permits

6. Timeframe performance

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

  • 77 per cent for pesticide products
  • 84 per cent for veterinary medicines products
  • 95 per cent for actives
  • 80 per cent for permits

7. Work in progress

At the end of June quarter 2018, there were:

  • 1306 applications in progress
    • 784 product applications
    • 357 active applications
    • 165 permit applications
  • 83 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 June quarter 2018:

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

8.1. Other regulatory assessments—June quarter 2018

Assessment type

Commenced

Finalised

In progress

Finalised within timeframe (%)

Technical assessment

2

8

5

63%

Items 8L, 8M, 8P

236

212

50

36%

Notifiable variations

141

126

15

100%

9. Consents to import

In the June quarter 2018, 164 consents to import were issued.

9.1. Consents to import—June 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%

Jun 18 159 165 164 14 90%

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.

10. Certificates of export

In the June quarter 2018, 47 certificates of export were issued.

10.1. 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%

Jun 18 51 47 6 6 92%

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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