Analysis by type of application

Types of regulatory decisions*

Commenced

Finalised/issued

In progress

Pre-application assistance

53

31

21

Product registration—pesticides

289

309

477

Product registration—veterinary medicines

253

248

296

Actives

62

274

146

Permits

153

165

152

Items 8L, 8M, 8P

144

154

36

Technical assessment (Item 25)

6

2

9

Notifiable variations

192

191

1

Import consents

215

210

7

Certificates of export

158

149

8

Total

1525

1733

1153

*See description of application types

1.1. Applications processed—September quarter 2018

 

Commenced

Finalised

Finalised within timeframe

2017–18 in timeframe

In Progress

In progress still within timeframe

Pesticides

289

309

80%

63%

477

89%

Veterinary medicines

253

248

88%

81%

296

70%

Total Products

542

557

83%

70%

773

81%

Permits

153

165

79%

67%

152

90%

Actives

62

274

99%

86%

146

84%

Total

757

996

86%

73%

1071

83%

2. Pre-application assistance

In the September quarter 2018:

  • 631 were received
  • 634 were processed
  • 99 per cent were completed within the 30-day timeframe.

2.1. Pre-application assistance—September quarter 2018

 

Received

Finalised

Within timeframe

In progress

Tier 1 (1 month)

21

14

93%

6

Tier 2 (2 months)

30

17

76%

12

Tier 3 (3 months)

2

0

N/A

3

Total

53

31

84%

21

* 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 September quarter 2018:

  • 631 were received
  • 634 were processed
  • 99 per cent were completed within the 30-day timeframe.

3.1. Preliminary assessment—September quarter 2018

Application Type

Received

Completed

Refused

Withdrawn

Within timeframe

Pesticides

300

296

1

1

99%

Veterinary medicines

106

119

0

0

99%

Total Products

406

415

1

1

99%

Permits

167

157

0

2

100%

Actives

58

62

0

1

96%

Total

631

634

1

4

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 September quarter 2018, 757 applications were commenced

  • 542 for products
  • 62 for actives
  • 153 for permits

5. Applications finalised

In the September quarter 2018, 996 applications were finalised

  • 557 for products
  • 274 for actives
  • 165 for permits

Timeframe performance

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

  • 80 per cent for pesticide products
  • 88 per cent for veterinary medicines products
  • 96 per cent for actives
  • 79 per cent for permits

Work in progress

At the end of September quarter 2018, there were:

  • 1071 applications in progress
    • 773 product applications
    • 152 active applications
    • 146 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.

Technical assessment, notifiable variations, holders and nominated agents

In the September 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.

5.1. Other regulatory assessments—September quarter 2018

Assessment type

Commenced

Finalised

In progress

Finalised within timeframe (%)

Technical assessment

6

2

9

0%

Items 8L, 8M, 8P

144

154

36

85%

Notifiable variations

192

191

1

100%

6. Consents to import

In the September quarter 2018, 208 consents to import were issued.

6.1. Consents to import—September quarter 2018

Quarter

Received

Finalised

Issued

In progress

Finalised within
targeted time (%)

Sep 18

215

210

208

7

  85%

Total

215

210

208

7

  85%

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.

7. Certificates of export

In the September quarter 2018, 149 certificates of export were issued.

7.1. Certificates of export—September quarter 2018

Quarter

Received

Issued

Not issued

In progress

Finalised within
targeted time (%)

Sep 18

158

149

3

8

  65%

Total

158

149

3

8

  65%

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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