Analysis by type of application

1. Summary of activities related to regulatory decisions—June quarter 2017

*See description of application types.

1.1. Applications Processed—June quarter 2017

2. Pre-application assistance

In June quarter 2017:

• 29 applications were received
• 31 applications were finalised
• 34 applications were in progress at the end of the quarter.

2.1. Pre-application assisance—June quarter 2017

* 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 tiers is based on the complexity and effort required to provide the assistance.

3. Preliminary assessment

In June quarter 2017:

• 99 per cent were completed within the 30 day timeframe
• 696 were received
• 754 were processed

3.1. Preliminary assessment—June quarter 2017

Preliminary assessment is an administrative check of all applications received to ensure the information necessary to proceed to a full evaluation is present.  The timeframe for preliminary assessment 30 days from receipt.

4. Applications commenced

In June quarter 2017, 842 applications were commenced

• 441 for products
• 242 for actives
• 159 for permits

5. Applications finalised

In June quarter 2017, 596 applications were finalised

• 368 for products
• 114 for actives
• 114 for permits

6. Timeframe performance

In June quarter 2017, timeframe performance results product applications were:

• 24 per cent for pesticide products
• 75 per cent for veterinary medicines products
• 93 per cent for actives
• 71 per cent for permits

7. Work in progress

At the end of June quarter 2017, there were:

• 1650 applications in progress
  • 1054 product applications
  • 370 active applications
  • 226 permit applications
• 71 per cent were within timeframe

Work in progress is an indicator of the future 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 June quarter 2017:

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

8.1. Other regulatory assessments—June quarter 2017

9. Consents to import

In June quarter 2017, 378 consents to import were issued.

9.1. Import consents—June quarter 2017

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 June quarter 2017, 75 certificates of export were issued.

10.1. Export certificates—June quarter 2017

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 are no statutory timeframes for the APVMA to process these but try to complete them within 20 working days.