Analysis by type of application

Types of regulatory decisions*

Commenced

Finalised/issued

In progress

Pre-application assistance

35

39

31

Product registration—pesticides

320

397

464

Product registration—veterinary medicines

128

138

291

Actives

146

140

309

Permits

127

128

158

Items 8L, 8M, 8P

162

140

28

Technical assessment (Item 25)

2

5

11

Notifiable variations

170

232

106

Import consents

160

199

34

Certificates of export

61

58

19

Total

1311

1476

1451

*See description of application types.

Applications processed—December quarter 2017

 

Commenced

Finalised

Finalised within timeframe

2016/17 in timeframe

In progress

In progress still within timeframe

Pesticides

320

397

72%

45%

464

81%

Veterinary medicines

128

138

71%

77%

291

67%

Total Products

448

535

72%

59%

755

76%

Actives

146

140

80%

88%

309

72%

Permits

127

128

76%

71%

158

72%

Total

721

803

74%

69%

1222

78%

Pre-application assistance

In the December quarter 2017:

  • 35 applications were received
  • 39 applications were finalised
  • 31 applications were in progress at the end of the quarter.

1.1. Pre-application assistance—December quarter 2017

 

Received

Finalised

Within timeframe

In progress

Tier 1 (1 month)

13

17

8

9

Tier 2 (2 months)

21

22

4

20

Tier 3 (3 months)

1

0

0

2

Total

35

39

12

31

* 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.

2. Preliminary assessment

In the December quarter 2017:

  • 651 were received
  • 686 were processed
  • 99 per cent were completed within the 30–day timeframe

2.1. Preliminary assessment—December quarter 2017

Application type

Received

Completed

Refused

Withdrawn

Within timeframe

Pesticides

276

308

0

1

100%

Veterinary medicines

119

105

0

0

97%

Total Products

395

413

0

1

99%

Permits

105

127

0

1

100%

Actives

151

146

0

2

98%

Total

651

686

0

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.

3. Applications commenced

In the December quarter 2017, 721 applications were commenced

  • 448 for products
  • 146 for actives
  • 127 for permits

 

4. Applications finalised

In the December quarter 2017, 803 applications were finalised

  • 535 for products
  • 140 for actives
  • 128 for permits

 

5. Timeframe performance

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

  • 72 per cent for pesticide products
  • 71 per cent for veterinary medicines products
  • 80 per cent for actives
  • 76 per cent for permits

 

6. Work in progress

At the end of December quarter 2017, there were:

  • 1222 applications in progress
    • 755 product applications
    • 309 active applications
    • 158 permit applications
  • 78 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.

7. Technical assessment, notifiable variations, holders and nominated agents

In the December quarter 2017:

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

7.1. Other regulatory assessments—December quarter 2017

Assessment type

Commenced

Finalised

In progress

Finalised within timeframe (%)

Technical assessment

2

5

11

60%

Items 8L, 8M, 8P

162

140

28

96%

Notifiable variations

170

232

106

100%

8. Consents to import

In the December quarter 2017, 194 consents to import were issued.

8.1. Import consents—December quarter 2017

Quarter

Received

Finalised

Issued

In progress

Finalised within
targeted time (%)

September 2017

194

182

177

28

94%

December 2017

160

199

194

34

12%

Total

354

381

371 (97%)

34

51%

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.

9. Certificates of export

In the December quarter 2017, 58 certificates of export were issued.

9.1. Export certificates—December quarter 2017

Quarter

Received

Issued

Not Issued

In progress

Finalised within
targeted time (%)

September 2017

122

94

0

28

80%

December 2017

61

58

1

19

25%

Total

183

152

1

19

59%

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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