Analysis by type of application

Types of regulatory decisions

Commenced

Finalised/issued

In progress

Pre-application assistance

50

57

39

Product registration – pesticides

271

291

387

Product registration – veterinary medicines

163

158

230

Permits

176

155

248

Actives

68

78

143

Items 8L, 8M, 8P

292

132

210

Technical assessment (Item 25)

2

1

9

Notifiable variations

204

204

0

Import consents

153

194

5

Certificates of export

171

168

21

Total

1 550

1 438

1 292

* See description of application types

1.1. Applications processed – June quarter 2021

Type

Commenced

Finalised

Finalised within timeframe

2019–20 in timeframe

In progress

In progress still within timeframe

Pesticides

271

291

99%

92%

387

97%

Veterinary medicines

163

158

100%

89%

230

96%

Total products

434

449

99%

91%

617

97%

Permits

176

155

70%

81%

248

81%

Actives

68

78

99%

85%

143

94%

Total

678

682

93%

88%

1 008

92%

2. Pre-application assistance

In the June quarter 2021:

  • 50 applications were received
  • 57 applications were finalised
  • 39 applications were in progress at the end of the quarter.

2.1. Pre-application assistance – June quarter 2021

Type

Received

Finalised

Within timeframe

In progress

Tier 1 (1 month)

10

15

12

5

Tier 2 (2 months)

33

39

20

26

Tier 3 (3 months)

7

3

2

8

Total

50

57

34

39

* 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 June quarter 2021:

  • 621 were received
  • 628 were processed
  • 99% were completed within timeframe.

3.1. Preliminary assessment – June quarter 2021

Application type

Received

Completed

Refused

Withdrawn

Within timeframe

Pesticides

279

264

0

0

98%

Veterinary medicines

119

111

0

1

99%

Total products

398

375

0

1

99%

Permits

152

180

0

6

98%

Actives

71

73

0

1

100%

Total

621

628

0

8

99%

4. Applications commenced

In the June quarter 2021, 678 applications were commenced.

  • 434 for products
  • 176 for permits
  • 68 for actives

Applications commenced, June quarter 2021

5. Applications finalised

In the June quarter 2021, 682 applications were finalised.

  • 449 for products
  • 155 for permits
  • 78 for actives

Applications finalised, June quarter 2021

6. Timeframe performance

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

  • 99% for pesticide products
  • 100% for veterinary medicines products
  • 70% for permits
  • 99% for actives.

Timeframe performance, June 2021

7. Work in progress

At the end of June quarter 2021, there were:

  • 1008 applications in progress:
    • 617 product applications
    • 248 permit applications
    • 143 active applications.

92% were within timeframe.

Work in progress, June quarter 2021

Work in progress within timeframe, June 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 June quarter 2021:

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

8.1. Other regulatory assessments – June quarter 2021

Assessment type

Commenced

Finalised

In progress

Finalised within timeframe (%)

Technical assessments

2

1

9

100%

Items 8L, 8M, 8P

292

132

210

100%

Notifiable variations

204

204

0

100%

9. Consents to import

In June quarter 2021, 173 consents to import were issued.

9.1. Consents to import – June quarter 2021

Quarter

Received

Finalised

Issued

In progress

Finalised within targeted time (%)

June 2021

153

194

173

5

89%

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 June quarter 2021, 90 certificates of export were issued.

10.1. Certificates of export – June quarter 2021

Quarter

Received

Issued

Not issued

In progress

Finalised within targeted time (%)

June 2021

171

168

1

21

77%

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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