Analysis by type of application

1. Summary

Types of regulatory decisions* Commenced Finalised/issued In progress
Pre-application assistance 32 32 37
Product registration—pesticides 180 156 524
Product registration—veterinary medicines 176 164 326
Actives 187 199 300
Permits 132 110 171
Items 8L, 8M, 8P 22 96 10
Technical assessment (Item 25) 7 1 16
Notifiable variations 186 141 84
Import consents 112 115 0
Certificates of export 94 95 10
Total 1128 1129 1478

*See description of application types.

2. Pre-application assistance

In December quarter 2016:

  • 32 applications were received
  • 32 applications were finalised
  • 37 applications were in progress at the end of the quarter.

2.1. Pre-application assistance—December quarter 2016

  Received Finalised Within timeframe In progress
Tier 1 (1 month) 12 9 2 10
Tier 2 (2 months) 17 19 3 23
Tier 3 (3 months) 3 4 1 4
Pre November 2015* 0 0 0 0
Total 32 32 6 37

* 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 and effort required to provide the assistance.

3. Preliminary assessment

In December quarter 2016:

  • 99 per cent were completed within the 30 day timeframe
  • 564 were received
  • 654 were processed
  • 97 per cent went into evaluation.

3.1. Preliminary assessment—December quarter 2016

Application type Received Completed Refused Withdrawn Within timeframe
Pesticides 224 190 0 0 100%
Veterinary medicines 93 87 0 0 100%
Total products 317 277 0(0%) 0(0%) 100%
Permits 124 130 5 3 98%
Actives 214 190 0 0 100%
Total 655 597 5(0.8%) 3(0.5%) 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 is 30 days from receipt.

4. Applications commenced

In December quarter 2016:

  • 675 applications were commenced
    • 356 for products
    • 187 for actives
    • 132 for permits.

Table of applications commenced in December quarter 2016; 675 applications were commenced, 356 for products, 187 for actives, 132 for permits

 

5. Applications finalised

In December quarter 2016:

  • 629 applications were finalised
    • 320 for products
    • 199 for actives
    • 110 for permits.

Table of applications finalised in December quarter 2016, 629 applications were finalised, 320 for products, 199 for actives, 110 for permits

6. Timeframe performance

In December quarter 2016, timeframe performance results for product applications were:

  • 50 per cent for pesticide products
  • 87 per cent for veterinary medicines products
  • 88 per cent for actives
  • 83 per cent for permits.

Timeframe performance in December quarter 2016, 50 per cent for pesticide products, 78 per cent for veterinary medicines products, 88 per cent for actives, 83 per cent for permits

7. Work in progress

At the end of December quarter 2016, there were:

  • 1321 applications in progress
    • 850 product applications
    • 300 active applications
    • 171 permit applications
  • 74 per cent were within timeframe.

work in progress at the end of December quarter 2016,, 1321 applications in progress, 850 product applications, 300 active applications, 171 permit applications, 74 per cent were within timeframe

 

work in progress at the end of December quarter 2016,, 1321 applications in progress, 850 product applications, 300 active applications, 171 permit applications, 74 per cent were within timeframe

 

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 December quarter 2016:

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

8.1. Other regulatory assessments—December quarter 2016

Assessment type Commenced Finalised In progress Finalised within timeframe (%)
Technical assessment 7 1 16 0%
Items 8L, 8M, 8P 22 96 10 8%
Notifiable variations 186 141 84 100%

9. Consents to import

In December quarter 2016, 107 consents to import were issued.

9.1. Import consents—December quarter 2016

Quarter Received Finalised Issued In progress Finalised within timeframe (%)
1 148 141 132 17 92%
2 112 115 107 0 96%
Total 260 256 239 (93%) 0 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 December quarter 2016, 167 certificates of export were issued.

10.1. Export certificates—December quarter 2016

Quarter Received Issued Not Issued In progress Finalised within timeframe (%)
1 60 64 0 3 69%
2 94 95 0 10 87%
Total 154 159 0 10 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 are no statutory timeframes to process these but the APVMA endeavours to complete them within 20 working days.

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