Analysis by type of application

1. Summary of activities related to regulatory decisions – September quarter 2021

WIP = Work in process.

See description of application types.

1.1. Applications processed – September quarter 2021

Please note that emergency permits (Item 22) do not have a numerical statutory timeframe. The APVMA must determine the application as soon as is practicable in the circumstances of the case (see Emergency permits).

2. Pre-application assistance

Pre-application assistance (PAA) is an optional, three-tiered, fee-based service for 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. Emergency permits

Emergency permits (Item 22) do not have a numerical statutory timeframe. The APVMA must determine the application as soon as is practicable in the circumstances of the case. In the September quarter 2021, the APVMA issued 16 emergency permits, taking an average of 33 days, with a range of 13 to 146 days.

4. Technical assessment, notifiable variations, holders and nominated agents

5. Consents to import

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.

6. Certificates of Export

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.