The Australian Pesticides and Veterinary Medicines Authority (APVMA) will retire the 21-day service level standard ‘fast-track’ option for Item 8 applications from 1 July 2023.
Item 8 applications are applications to register a product that is the same as a reference product (also known as a ‘repack’).
The fast-track option was introduced in 2016 for Item 8 applications that meet certain criteria. The APVMA’s service level standard has been to complete assessment of these applications in 21 days instead of the 3-month statutory timeframe.
Many nominated reference product labels cannot be accepted to register a new product under an Item 8 application because the label text requires updating in accordance with contemporary standards.
Requests from the APVMA to address these amendments, including label amendments requested under subsection 8C(2A) and Regulation 8AHAA of the Agvet Code, allow applicants 14 days to respond. These provisions have made it unfeasible for the APVMA to continue to meet the 21-day service level standard where a label update may be required.
Item 8 applications that meet the fast-track option criteria and are received up to 30 June 2023 will be processed in accordance with the 21-day service level standard, provided no additional or clarifying information is required.
Item 8 applications received from 1 July 2023 onwards will be processed within the statutory 3-month timeframe.
Questions about the retirement of the fast-track option for Item 8 applications, or Item 8 applications in general may be directed to firstname.lastname@example.org.
Prior to 1 July 2023, an application is considered a fast-track Item 8 if:
- the nominated reference product is your own
- there are no protected data associated with your own nominated reference product
- the manufacturer’s declaration(s) are submitted at lodgement
- the full fee is paid at lodgement.
If an application is submitted as a fast-track but is found to be ineligible, it reverts to the statutory Item 8 timeframe of 3 months, which will apply to all Item 8 applications from 1 July 2023 onwards.