Analysis by type of application

Types of regulatory decisions*

Commenced

Finalised/issued

In progress

Pre-application assistance

29

31

34

Product registration—pesticides

279

233

671

Product registration—veterinary medicines

162

135

383

Actives

242

114

370

Permits

159

114

226

Items 8L, 8M, 8P

70

67

17

Technical assessment (Item 25)

3

3

14

Notifiable variations

425

441

53

Import consents

365

378

6

Certificates of export

76

75

19

Total

1810

1591

1793

*See description of application types.

1.1. Applications Processed—June quarter 2017

 

Commenced

Finalised

Finalised Within Timeframe

2015/16 in timeframe

In Progress

In progress still within timeframe

Pesticides

279

233

24%

57%

671

62%

Veterinary medicines

162

135

75%

80%

383

76%

Total Products

441

368

43%

66%

1054

67%

Permits

159

114

71%

70%

226

65%

Actives

242

114

93%

70%

370

88%

Total

842

596

58%

68%

1650

71%

2. Pre-application assistance

In June quarter 2017:

  • 29 applications were received
  • 31 applications were finalised
  • 34 applications were in progress at the end of the quarter.

2.1. Pre-application assisance—June quarter 2017

 

Received

Finalised

Within timeframe

In progress

Tier 1 (1 month)

4

10

3

7

Tier 2 (2 months)

22

18

7

25

Tier 3 (3 months)

3

2

1

2

Pre November 2015*

0

1

0

0

Total

29

31

11

34

* 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 tiers is based on the complexity and effort required to provide the assistance.

3. Preliminary assessment

In June quarter 2017:

  • 99 per cent were completed within the 30 day timeframe
  • 696 were received
  • 754 were processed

3.1. Preliminary assessment—June quarter 2017

Application Type

Received

Completed

Refused

Withdrawn

Within timeframe

Pesticides

279

281

2

1

100%

Veterinary medicines

99

75

0

4

98%

Total Products

378

356

2(0.6%)

5(1.4%)

99%

Permits

131

157

0

2

100%

Actives

187

241

0

2

100%

Total

696

754

2(0.3%)

9(1.2%)

99%

Preliminary assessment is an administrative check of all applications received to ensure the information necessary to proceed to a full evaluation is present.  The timeframe for preliminary assessment 30 days from receipt.

4. Applications commenced

In June quarter 2017, 842 applications were commenced

  • 441 for products
  • 242 for actives
  • 159 for permits

 active applications 242, permit applications 159.

5. Applications finalised

In June quarter 2017, 596 applications were finalised

• 368 for products
• 114 for actives
• 114 for permits

 active applications 114, permit applications 114.

6. Timeframe performance

In June quarter 2017, timeframe performance results product applications were:

• 24 per cent for pesticide products
• 75 per cent for veterinary medicines products
• 93 per cent for actives
• 71 per cent for permits

 active applications 93%, permit applications 71%.

7. Work in progress

At the end of June quarter 2017, there were:

  • 1650 applications in progress
    • 1054 product applications
    • 370 active applications
    • 226 permit applications
  • 71 per cent were within timeframe

 active applications 370, permit applications 226.

 active applications 88%, permit applications 65%.

Work in progress is an indicator of the future 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 June quarter 2017:

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

8.1. Other regulatory assessments—June quarter 2017

Assessment type

Commenced

Finalised

In progress

Finalised within timeframe (%)

Technical assessment

3

3

14

0%

Items 8L, 8M, 8P

70

67

17

68%

Notifiable variations

425

441

53

100%

9. Consents to import

In June quarter 2017, 378 consents to import were issued.

9.1. Import consents—June quarter 2017

Quarter

Received

Finalised

Issued

In progress

Finalised within timeframe (%)

Sep 16

148

141

132

17

92%

Dec 16

112

115

107

0

96%

Mar 17

178

147

145

0

99%

Jun 17

365

385

378

6

94%

Total

803

788

762 (96%)

6

93%

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 June quarter 2017, 75 certificates of export were issued.

10.1. Export certificates—June quarter 2017

Quarter

Received

Issued

Not Issued

In progress

Finalised within timeframe (%)

Sep 16

72

72

0

3

69%

Dec 16

96

95

0

10

87%

Mar 17

99

93

1

19

71%

Jun 17

76

75

16

19

59%

Total

343

335

17

19

72%

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 are no statutory timeframes for the APVMA to process these but try to complete them within 20 working days.

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