Analysis by type of application

1. Summary of activities related to regulatory decisions—1 July to 31 December 2019

*See description of application types.

1.1. Applications processed 1 July–31 December 2019

2. Pre-application assistance

Between 1 July and 31 December 2019:

• 163 applications were received
• 248 applications were finalised
• 39 applications were in progress at the end of the quarter.

2.1. Pre-application assistance—1 July to 31 December 2019

* 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.

3. Preliminary assessment

Between 1 July and 31 December 2019:

• 1330 were received
• 1306 were processed
• 99 per cent were completed within the one month timeframe.

3.1. Preliminary assessment—1 July to 31 December 2019

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 APVMA must complete a preliminary assessment of an application within one month after it is lodged.

4. Applications commenced

In the December quarter 2019, the APVMA commenced 684 applications.

• 511 for products
• 96 for permits
• 77 for actives.

5. Applications finalised

In the December quarter 2019, the APVMA finalised 724 applications.

• 506 for products
• 114 for permits
• 104 for actives.

6. Timeframe performance

In the December quarter 2019, timeframe performance results for applications were:

• 92 per cent for pesticide products
• 82 per cent for veterinary medicines products
• 85 per cent for permits
• 80 per cent for actives.

7. Work in progress

At the end of December 2019, there were:

• 1247 applications in progress
  • 832 product applications
  • 224 permit applications
  • 191 active applications
• 89 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.

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

Between 1 July and 31 December 2019:

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

8.1. Other regulatory assessments—1 July to 31 December 2019

9. Consents to import

Between 1 July and 31 December 2019, the APVMA issued 238 consents to import.

9.1. Consents to import—1 July to 31 December 2019

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

Between 1 July and 31 December 2019, the APVMA issued 221 certificates of export.

10.1. Certificates of export—1 July to 31 December 2019

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.