Analysis by type of application

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

*See description of application types

Applications processed – December quarter 2020

2. Pre-application assistance

In the December quarter 2020:

• 52 applications were received
• 35 applications were finalised
• 17 applications were in progress at the end of the quarter.

Pre-application assistance – December 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 December quarter 2020:

• 689 were received
• 697 were processed
• 99% were completed within timeframe.

Preliminary assessment– December quarter 2020

4. Applications commenced

In the December quarter 2020, 884 applications were commenced.

• 665 for products
• 150 for permits
• 69 for actives

5. Applications finalised

In the December quarter 2020, 1019 applications were finalised.

• 807 for products
• 137 for permits
• 75 for actives

6. Timeframe performance

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

• 99% for pesticide products
• 99% for veterinary medicines products
• 75% for permits
• 100% for actives.

7. Work in progress

At the end of December quarter 2020, there were:

• 1,121 applications in progress:
  • 693 product applications
  • 253 permit applications
  • 175 active applications.
• 91% 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 December quarter 2020:

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

Other regulatory assessments – December quarter 2020

9. Consents to import

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

Consents to import – December 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 December quarter 2020, 110 certificates of export were issued.

Certificates of export – December 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.