Analysis by type of application

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

WIP = Work in process.

See description of application types.

Applications processed – December quarter 2021

Note: 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. PAAs do not have a numerical statutory timeframe; the target timeframe for each tier is based on the anticipated 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 December quarter 2021, the APVMA issued 17 emergency permits, taking an average of 22 days, with a range of 3 to 82 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.