Analysis by type of application

Types of regulatory decisions*

Commenced

Finalised/issued

In progress

Pre-application assistance

27

30

35

Product registration—pesticides

275

403

542

Product registration—veterinary medicines

224

310

301

Actives

103

177

299

Permits

102

168

161

Items 8L, 8M, 8P

230

241

6

Technical assessment (Item 25)

5

5

14

Notifiable variations

216

124

160

Import consents

194

182

28

Certificates of export

122

94

28

Total

1498

1734

1574

*See description of application types.

1.1. Applications processed—September quarter 2017

 

Commenced

Finalised

Finalised Within Timeframe

2016/17 in timeframe

In Progress

In progress still within timeframe

Pesticides

275

403

36%

45%

542

73%

Veterinary medicines

224

310

76%

77%

301

68%

Total Products

499

713

53%

59%

843

71%

Actives

103

177

82%

88%

299

85%

Permits

102

168

52%

71%

161

70%

Total

704

1058

58%

69%

1303

74%

2. Pre-application assistance

In the September quarter 2017:

  • 27 applications were received
  • 30 applications were finalised
  • 35 applications were in progress at the end of the quarter.

2.1. Pre-application assistance—September quarter 2017

 

Received

Finalised

Within timeframe

In progress

Tier 1 (1 month)

11

10

2

10

Tier 2 (2 months)

15

16

3

23

Tier 3 (3 months)

1

4

2

2

Total

27

30

7

35

* 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 2017:

  • 622 were received
  • 604 were processed
  • 99 per cent were completed within the 30-day timeframe

3.1. Preliminary assessment—September quarter 2017

Application Type

Received

Completed

Refused

Withdrawn

Within timeframe

Pesticides

302

295

3

0

98%

Veterinary medicines

117

101

0

0

100%

Total Products

419

396

3(0.7%)

0(0%)

98%

Permits

118

104

3

0

100%

Actives

85

104

0

1

100%

Total

622

604

6(1%)

1(0.1%)

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 2017, 704 applications were commenced

  • 499 for products
  • 103 for actives
  • 102 for permits

5. Applications finalised

In the September quarter 2017, 1058 applications were finalised

  • 713 for products
  • 177 for actives
  • 168 for permits

6. Timeframe performance

In the September quarter 2017, timeframe performance results for applications were:

  • 36 per cent for pesticide products
  • 76 per cent for veterinary medicines products
  • 82 per cent for actives
  • 52 per cent for permits

7. Work in progress

At the end of September quarter 2017, there were:

  • 1303 applications in progress
    • 843 product applications
    • 299 active applications
    • 161 permit applications
  • 74 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 September quarter 2017:

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

8.1. Other regulatory assessments—September quarter 2017

Assessment type

Commenced

Finalised

In progress

Finalised within timeframe (%)

Technical assessment

5

5

14

40%

Items 8L, 8M, 8P

230

241

6

91%

Notifiable variations

216

124

160

100%

9. Consents to import

In the September quarter 2017, 177 consents to import were issued.

9.1. Import consents—September quarter 2017

Quarter

Received

Finalised

Issued

In progress

Finalised within
targeted time (%)

Sep 17

194

182

177

28

94%

Total

194

182

177 (97%)

28

94%

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 September quarter 2017, 94 certificates of export were issued.

10.1. Export certificates—September quarter 2017

Quarter

Received

Issued

Not Issued

In progress

Finalised within
targeted time (%)

Sep 17

122

94

0

28

80%

Total

122

94

0

28

80%

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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