It is important that the Australian Pesticides and Veterinary Medicines Authority (APVMA) receives complete applications that meet the statutory criteria, as that assists us to be an efficient regulator.
To help ensure we receive the appropriate information in an application, the APVMA is releasing this update on application requirements for Item 6 and 7 Applications.
Applications to register a new chemical product sometimes rely on the new chemical product being closely similar to a reference chemical product. In these cases, the applicant asks the APVMA to consider the data on the nominated reference product, without requiring the submission of any (Item 7) or minimal (Item 6) further supporting technical data with their application.
The APVMA is clarifying expectations as to what data must be held by the nominated reference product to meet our application requirements.
This change will take effect immediately and will also apply to all Item 6 and 7 applications currently with the APVMA.
Requirements* the application must contain
The Application Requirements laid out in the Agricultural and Veterinary Chemicals Code Act 1994, and the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014, set out what an application must contain.
Among these requirements, applications must contain or be accompanied by:
- supporting technical data relevant to whether the chemical product that is the subject of the application meets the safety, efficacy and trade criteria.
If the application does not specifically contain or attach this information, it can only meet the application requirements if the APVMA holds sufficient information for the nominated reference product, including supporting technical data.
To assist with submission of a complete application, we encourage applicants to check PubCRIS prior to lodging an Item 6 or 7 application and confirm:
- if their nominated reference product has data items associated with it
- that those data items appear to meet the requirements of the Application Instrument
- whether any limits on use of information have expired.
To make this process as straightforward as possible, we have updated PubCRIS so that data items previously relied on for a registered chemical product remain visible even after the limits on use have expired.
During Preliminary Assessment
At this point, we consider whether the information included with the application, together with that held by the APVMA for the nominated reference product, appear to meet the application requirements.
If it appears that these application requirements are not met, but the defects can reasonably be rectified, we will issue a defect notice under s11(3) of the Agvet Code. At that point, applicants will have one month to either nominate a different reference product or provide additional information to rectify the defects. If the APVMA is satisfied that the defects have been remedied, the application will pass through to evaluation.
If the defects have not been rectified, or it appears to the APVMA that the defects cannot be reasonably rectified, the application must be refused because it does not meet the application requirements.
Once the application enters evaluation
Scientific staff will conduct the detailed review of the application. This will include an assessment of the relevance and adequacy of the information held by us for the nominated reference product and whether there is sufficient information to be satisfied that the proposed product can meet the safety, efficacy, and trade criteria.
If we are satisfied that the application and the proposed product meet all the statutory criteria, we will register the product as per s14 of the Agvet Code. If we are not satisfied, we will usually issue a notice under s8S of the Agvet Code proposing to refuse the application and invite written submissions from the applicant.
If the applicant provides a written response that satisfies us that the statutory criteria can be met, we will register the product. However, we will generally not agree to a request to consider data held by us for a new reference product. We will also generally not consider anything that is unrelated to the information already provided by the applicant or included in the 8S notice.
Item 6 and 7 applications that have already passed preliminary assessment
As an interim measure only, Item 6 and 7 applications that have already passed preliminary assessment should have an opportunity to nominate an alternative reference product if we determine that we do not hold the necessary information for the reference product nominated in their application.
What this means for other application Items
While this update is specific to Item 6 and 7 applications, we are reviewing our position in relation to the use of reference products more generally and anticipate further updates soon.
Thank you for supporting the APVMA’s measures to safely regulate products.
*The requirements are set out in section 8A and referred to in sections 11(3) and 14(1)(a) of the Agvet Code. (Agricultural and Veterinary Chemicals Code (Application Requirements) instrument 2014 (Application Instrument).