Analysis by type of application

1. Summary of activities related to regulatory decisions – September quarter 2020

*See description of application types.

1.1. Applications processed – September quarter 2020

2. Pre-application assistance

In the September quarter 2020:

• 87 applications were received
• 28 applications were finalised
• 59 applications were in progress at the end of the quarter.

2.1. Pre-application assistance – September 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

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 September quarter 2020:

• 598 were received
• 772 were processed
• 98% were completed within timeframe.

3.1. Preliminary assessment – September quarter 2020

4. Applications commenced

In the September quarter 2020, 1004 applications were commenced:

• 816 for products
• 117 for permits
• 71 for actives.

5. Applications finalised

In the September quarter 2020, 1016 applications were finalised:

• 773 for products
• 167 for permits
• 76 for actives.

6. Timeframe performance

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

• 98% for pesticide products
• 98% for veterinary medicines products
• 78% for permits
• 96% for actives.

7. Work in progress

At the end of September quarter 2020, there were:

• 1253 applications in progress:
  • 832 product applications
  • 239 permit applications
  • 182 active applications
• 92% 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 September quarter 2020:

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

8.1. Other regulatory assessments – September quarter 2020

9. Consents to import

In the September quarter 2020, 128 consents to import were issued.

9.1. Consents to import – September quarter 2020

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 September quarter 2020, 124 certificates of export were issued.

10.1. Certificates of export – September quarter 2020

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.