Analysis by type of application

Types of regulatory decisions*

Commenced

Finalised/issued

In progress

Pre-application assistance

36

22

13

Product registration—pesticides

237

285

434

Product registration—veterinary medicines

139

115

273

Actives

68

76

161

Permits

120

133

183

Items 8L, 8M, 8P

248

212

66

Technical assessment (Item 25)

0

5

7

Notifiable variations

183

182

1

Import consents

146

142

0

Certificates of export

86

61

38

Total

1263

1233

1176

*See description of application types

1.1. Applications processed—March quarter 2019

 

Commenced

Finalised

Finalised within timeframe

2017–18 in timeframe

In Progress

In progress still within timeframe

Pesticides

237

285

89%

63%

434

86%

Veterinary medicines

139

115

73%

81%

273

69%

Total Products

376

400

85%

70%

707

79%

Permits

120

133

87%

67%

183

84%

Actives

68

76

87%

86%

161

88%

Total

564

609

85%

73%

1051

81%

2. Pre-application assistance

In the March quarter 2019:

  • 36 applications were received
  • 22 applications were finalised
  • 13 applications were in progress at the end of the quarter.

2.1. Pre-application assistance—March quarter 2019

 

Received

Finalised

Within timeframe

In progress

Tier 1 (1 month)

12

8

1

2

Tier 2 (2 months)

19

13

7

6

Tier 3 (3 months)

5

1

0

5

Total

36

22

8

13

* 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 2019:

  • 531 were received
  • 503 were processed
  • 99 per cent were completed within the 30-day timeframe.

3.1. Preliminary assessment—March quarter 2019

Application Type

Received

Completed

Refused

Withdrawn

Within timeframe

Pesticides

234

235

0

0

100%

Veterinary medicines

99

75

0

1

100%

Total Products

333

310

0

1

100%

Permits

132

124

1

1

99%

Actives

66

69

0

0

100%

Total

531

503

1

2

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 2019, 564 applications were commenced.

  • 376 for products
  • 68 for actives
  • 120 for permits.

Applications commenced March quarter 2019

5. Applications finalised

In the March quarter 2019, 609 applications were finalised.

  • 400 for products
  • 76 for actives
  • 133 for permits.

Applications finalised March quarter 2019

6. Timeframe performance

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

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

Timeframe performance March quarter 2019

7. Work in progress

At the end of March quarter 2019, there were:

  • 1051 applications in progress
    • 707 product applications
    • 161 active applications
    • 183 permit applications
  • 81 per cent were within timeframe.

Work in progress March quarter 2019

Work in progress March quarter 2019

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 2019:

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

8.1. Other regulatory assessments—March quarter 2019

Assessment type

Commenced

Finalised

In progress

Finalised within timeframe (%)

Technical assessment

0

5

7

80%

Items 8L, 8M, 8P

248

212

66

99%

Notifiable variations

183

182

1

100%

9. Consents to import

In the March quarter 2019, 121 consents to import were issued.

9.1. Consents to import—March quarter 2019

Quarter

Received

Finalised

Issued

In progress

Finalised within
targeted time (%)

Sep 18

215

210

208

7

85%

Dec 18

85

90

79

4

42%

Mar 19

146

142

121

0

85%

Total

446

442

408

0

76%

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 2019, 61 certificates of export were issued.

10.1. Certificates of export—March quarter 2019

Quarter

Received

Issued

Not issued

In progress

Finalised within
targeted time (%)

Sep 18

158

149

3

8

65%

Dec 18

59

76

0

14

71%

Mar 19 86 61 1 38 76%

Total

303

286

4

38

69%

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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