1. Summary of activities related to regulatory decisions—March quarter 2020

*See description of application types.

1.1. Applications processed—March quarter 2020

2. Pre-Application Assistance

In the March quarter 2020:

• 51 applications were received
• 48 applications were finalised
• 45 applications were in progress at the end of the quarter.

2.1. Pre-Application Assistance—March quarter 2020

* 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

In the March quarter 2020:

• 636 were received
• 674 were processed
• 98 per cent were completed within the one month timeframe.

3.1. Preliminary assessment—March quarter 2020

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 March quarter 2020, 759 applications were commenced:

• 464 for products
• 211 for permits
• 84 for actives

5. Applications finalised

In the March quarter 2020, 753 applications were finalised:

• 530 for products
• 135 for permits
• 88 for actives.

6. Timeframe performance

In the March quarter 2020, timeframe performance results for applications were:

• 97 per cent for pesticide products
• 87 per cent for veterinary medicines products
• 77 per cent for permits
• 89 per cent for actives.

7. Work in progress

At the end of March quarter 2020, there were:

• 1251 applications in progress:
  • 764 product applications
  • 299 permit applications
  • 188 active applications
• 89 per cent were within timeframe.

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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 the March quarter 2020:

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

8.1. Other regulatory assessments—March quarter 2020

9. Consents to import

In the March quarter 2020, 140 consents to import were issued.

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 2020, 64 certificates of export were issued.

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.