Analysis by type of application

Types of regulatory decisions

Commenced

Finalised/issued

In progress

Pre-application assistance

55

49

42

Product registration – pesticides

269

334

407

Product registration – veterinary medicines

157

153

224

Permits

140

162

230

Actives

56

78

152

Items 8L, 8M, 8P

205

190

50

Technical assessment (Item 25)

4

5

8

Notifiable variations

197

201

11

Import consents

200

186

2

Certificates of export

92

90

12

Total

1,375

1,448

1,138

* See description of application types.

1.1. Applications processed – March quarter 2021

Type

Commenced

Finalised

Finalised within timeframe

2019–20 in timeframe

In progress

In progress still within timeframe

Pesticides

269

334

99%

92%

407

99%

Veterinary medicines

157

153

99%

89%

224

96%

Total products

426

487

99%

91%

631

98%

Permits

140

162

70%

81%

230

67%

Actives

56

78

96%

85%

152

95%

Total

622

727

92%

88%

1,013

91%

2. Pre-application assistance

In the March quarter 2021:

  • 55 applications were received
  • 49 applications were finalised
  • 42 applications were in progress at the end of the quarter.

2.1. Pre-application assistance – March quarter 2021

Type

Received

Finalised

Within timeframe

In progress

Tier 1 (1 month)

23

16

11

12

Tier 2 (2 months)

30

28

18

28

Tier 3 (3 months)

2

5

3

2

Total

55

49

32

42

* This includes all PAAs received under the previous process.

Pre-application assistance (PAA) is an optional, three-tiered, fee-based service for 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

Preliminary assessment is a legislatively required administrative check of all applications to ensure the information necessary to proceed to a full evaluation is present. The timeframe for preliminary assessment is one month from lodgement.

In the March quarter 2021:

  • 573 were received
  • 551 were processed
  • 98% were completed within timeframe.

3.1. Preliminary assessment – March quarter 2021

Application type

Received

Completed

Refused

Withdrawn

Within timeframe

Pesticides

252

270

0

0

99%

Veterinary medicines

101

91

0

0

100%

Total products

353

361

0

0

99%

Permits

171

141

0

2

100%

Actives

49

49

2

0

90%

Total

573

551

2

2

98%

4. Applications commenced

In the March quarter 2021, 622 applications were commenced.

  • 426 for products
  • 140 for permits
  • 56 for actives

Applications commenced, March quarter 2021

5. Applications finalised

In the March quarter 2021, 727 applications were finalised.

  • 487 for products
  • 162 for permits
  • 78 for actives

Applications finalised, March quarter 2021

6. Timeframe performance

In the March quarter 2021, timeframe performance results for applications were:

  • 99% for pesticide products
  • 99% for veterinary medicines products
  • 70% for permits
  • 96% for actives.

Timeframe performance, March quarter 2021

7. Work in progress

At the end of March quarter 2021, there were:

  • 1013 applications in progress:
    • 631 product applications
    • 230 permit applications
    • 152 active applications.

91% were within timeframe.

Work in progress, March quarter 2021

Work in progress within timeframe, March quarter 2021

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 March quarter 2021:

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

8.1. Other regulatory assessments – March quarter 2021

Assessment type

Commenced

Finalised

In progress

Finalised within timeframe (%)

Technical assessments

4

5

8

100%

Items 8L, 8M, 8P

205

190

50

84%

Notifiable variations

197

201

11

100%

9. Consents to import

In March quarter 2021, 186 consents to import were issued.

9.1. Consents to import – March quarter 2021

Quarter

Received

Finalised

Issued

In progress

Finalised within targeted time (%)

March 2021

200

198

186

2

57%

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 March quarter 2021, 90 certificates of export were issued.

10.1. Certificates of export – March quarter 2021

Quarter

Received

Issued

Not issued

In progress

Finalised within targeted time (%)

March 2021

92

90

3

12

74%

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 certificates of export – the APVMA seeks to process these within 20 days.

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