Analysis by type of application

Types of regulatory decisions*

Commenced

Finalised/issued

In progress

Pre-application assistance

8

36

9

Product registration—pesticides

349

344

481

Product registration—veterinary medicines

194

245

244

Actives

89

63

170

Permits

161

117

195

Items 8L, 8M, 8P

93

99

30

Technical assessment (Item 25)

7

4

12

Notifiable variations

157

149

8

Import consents

85

90

4

Certificates of export

59

76

14

Total

1202

1223

1167

*See description of application types

1.1. Applications processed—December quarter 2018

 

Commenced

Finalised

Finalised within timeframe

2017–18 in timeframe

In Progress

In progress still within timeframe

Pesticides

349

344

86%

63%

481

87%

Veterinary medicines

194

245

80%

81%

244

64%

Total Products

543

589

83%

70%

725

79%

Permits

161

117

87%

67%

195

90%

Actives

89

63

91%

86%

170

89%

Total

793

769

85%

73%

1090

83%

2. Pre-application assistance

In the December quarter 2018:

  • 8 applications were received
  • 36 applications were finalised
  • 9 applications were in progress at the end of the quarter.

2.1. Pre-application assistance—December quarter 2018

 

Received

Finalised

Within timeframe

In progress

Tier 1 (1 month)

1

14

7%

0

Tier 2 (2 months)

7

20

30%

8

Tier 3 (3 months)

0

2

N/A

1

Total

8

36

19%

9

* 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 December quarter 2018:

  • 618 were received
  • 719 were processed
  • 99 per cent were completed within the 30-day timeframe.

3.1. Preliminary assessment—December quarter 2018

Application Type

Received

Completed

Refused

Withdrawn

Within timeframe

Pesticides

310

353

0

5

99%

Veterinary medicines

98

106

0

1

99%

Total Products

408

459

0

6

99%

Permits

126

169

5

2

100%

Actives

84

91

0

0

100%

Total

618

719

5

8

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 2018, 793 applications were commenced

  • 543 for products
  • 89 for actives
  • 161 for permits

APVMA applications commenced in the December 2018 quarter

5. Applications finalised

In the December quarter 2018, 769 applications were finalised

  • 589 for products
  • 63 for actives
  • 117 for permits

APVMA applications finalised in the December 2018 quarter

6. Timeframe performance

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

  • 86 per cent for pesticide products
  • 80 per cent for veterinary medicines products
  • 91 per cent for actives
  • 87 per cent for permits

APVMA timeframe performance in the December 2018 quarter

7. Work in progress

At the end of December quarter 2018, there were:

  • 1090 applications in progress
    • 725 product applications
    • 170 active applications
    • 195 permit applications
  • 83 per cent were within timeframe

APVMA work in process December quarter 2018

APVMA work in progress within timeframe December quarter 2018

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 December quarter 2018:

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

8.1. Other regulatory assessments—December quarter 2018

Assessment type

Commenced

Finalised

In progress

Finalised within timeframe (%)

Technical assessment

7

4

12

50%

Items 8L, 8M, 8P

93

99

30

68%

Notifiable variations

157

149

8

100%

9. Consents to import

In the December quarter 2018, 79 consents to import were issued.

9.1. Consents to import—December quarter 2018

Quarter

Received

Finalised

Issued

In progress

Finalised within
targeted time (%)

Sep 18

215

210

208

7

  85%

Dec 18

85

90

79

4

  42%

Total

300

300

287

4

  72%

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 December quarter 2018, 76 certificates of export were issued.

10.1. Certificates of export—December quarter 2018

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%

Total

217

225

3

14

  66%

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.

To protect your privacy, please do not include contact information in your feedback. If you would like a response, please contact us.