Analysis by type of application

1. Summary of activities related to regulatory decisions—December quarter 2018

*See description of?application types

1.1. Applications processed—December quarter 2018

2. Pre-application assistance

In the December quarter 2018:

• 8 applications were received
• 36 applications were finalised
• 9 applications were in progress at the end of the quarter.

2.1. Pre-application assistance—December quarter 2018

* 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 December quarter 2018:

• 618 were received
• 719 were processed
• 99 per cent were completed within the one month timeframe.

3.1. Preliminary assessment—December quarter 2018

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 2018, 793 applications were commenced

• 543 for products
• 89 for actives
• 161 for permits

5. Applications finalised

In the December quarter 2018, 769 applications were finalised

• 589 for products
• 63 for actives
• 117 for permits

6. Timeframe performance

In the December quarter 2018, timeframe performance results for applications were:

• 86 per cent for pesticide products
• 80 per cent for veterinary medicines products
• 91 per cent for actives
• 87 per cent for permits

7. Work in progress

At the end of December quarter 2018, there were:

• 1090 applications in progress
  • 725 product applications
  • 170 active applications
  • 195 permit applications
• 83 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 December quarter 2018:

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

8.1. Other regulatory assessments—December quarter 2018

9. Consents to import

In the December quarter 2018, 79 consents to import were issued.

9.1. Consents to import—December quarter 2018

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 2018, 76 certificates of export were issued.

10.1. Certificates of export—December quarter 2018

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.