Analysis by type of application

1. Summary of activities related to regulatory decisions—March quarter 2019

*See description of application types

1.1. Applications processed—March quarter 2019

2. Pre-application assistance

In the March quarter 2019:

• 36 applications were received
• 22 applications were finalised
• 13 applications were in progress at the end of the quarter.

2.1. Pre-application assistance—March quarter 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

In the March quarter 2019:

• 531 were received
• 503 were processed
• 99 per cent were completed within the one month timeframe.

3.1. Preliminary assessment—March quarter 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 March quarter 2019, 564 applications were commenced.

• 376 for products
• 68 for actives
• 120 for permits.

5. Applications finalised

In the March quarter 2019, 609 applications were finalised.

• 400 for products
• 76 for actives
• 133 for permits.

6. Timeframe performance

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

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

7. Work in progress

At the end of March quarter 2019, there were:

• 1051 applications in progress
  • 707 product applications
  • 161 active applications
  • 183 permit applications
• 81 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

In the March quarter 2019:

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

8.1. Other regulatory assessments—March quarter 2019

9. Consents to import

In the March quarter 2019, 121 consents to import were issued.

9.1. Consents to import—March quarter 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

In the March quarter 2019, 61 certificates of export were issued.

10.1. Certificates of export—March quarter 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.