For the purpose of determining an application in relation to an active constituent, chemical product, label or permit, we may seek additional, updated or clarifying information during the assessment period. The Australian Pesticides and Veterinary Medicines Authority (APVMA) can use the following pathways to request information from an applicant:
- Under section 159 of the Agvet Code
- Under section 8C(2A) of the Agvet Code
We will select the appropriate pathway based on the type of information required, in accordance with the relevant legislative provisions.
Section 159 of the Agvet Code
We may issue a section 159 notice to the applicant requiring them to provide specified information or to take a specified action. You may be required to take one or more of the following actions:
- give the APVMA information of a kind stated in a written notice, for example:
- information to support what has already been provided – for example, where reference is made to additional studies or information which has not been provided; or where the information provided is incomplete
- information to correct an error in the application – for example, where every second page is missing from a document or a document listed on the data list has not been provided.
- carry out a search of published literature for information about the active constituent, chemical product or any of its constituents, and give a report to the APVMA on the results of that search
- give a sample of the active constituent, or of the chemical product or any of its constituents, to the APVMA, or to another body determined by the APVMA or authority in order for it to be analysed by an approved analyst.
When we issue a notice of this kind, the assessment period for the application will be extended when the first notice is issued. The notice will specify the period in which a response must be provided. If a response is not received before the end of the period set out in the notice, a Notice of Proposal to Refuse Application will be issued and all further evaluation of the application will be put on hold until the period stated in the notice expires. If the outcome is to refuse the application, no further evaluation will be conducted prior to the refusal.
The Agvet Code Regulations use the following formula to prescribe the maximum period which can be included in this notice:
MP = XP - 1 month
MP means the maximum period
XP means the extended assessment period mentioned for the application in column 3 of Part 2 of Schedule 6 of the Agvet Code Regulations minus the assessment period mentioned for the application in column 2 of Part 2 of Schedule 6 of the Agvet Code Regulations.For example, if the assessment period for an application is three months, and the extended assessment period is five months (XP=5-3), then the maximum amount of time you have to respond to a notice requiring further information is one month (MP=2-1).
We may allow a further period if an extraordinary event or circumstance beyond your control prevents you from complying with the period stated in the notice. For a time shift application, the maximum period is the period agreed to by the APVMA and the applicant.
Subsection 8C(2A) of the Agvet Code
We may issue a request for updated or clarifying information under section 8C(2A) of the Agvet Code. The type of information we can request is prescribed in regulation 8AHAA of the Agricultural and Veterinary Chemicals Code Regulations 1995. This pathway is appropriate when we require minor updates to an application during the assessment period (for example, to correct typographical errors or request clarification of information already provided to the APVMA).
Applicants will have 14 days to provide the requested information. Requests made under this provision do not result in an extension to the application assessment timeframe.
It is important to note that we are unable to accept new data or information under this provision. If the applicant needs to provide new information (for example, new trial data or further information to support a proposed use pattern), we may issue a subsequent s159 notice to facilitate the provision of this new information or data.