This content is current only at the time of printing. This document was printed on 10 September 2020. A current copy is located at http://www.xlg888.com/node/11346
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Guidance on applications involving reference products
There are a range of applications to register agvet chemical products that nominate a reference product. The most common applications are to register generic products that are similar, closely similar or the same as an existing registered product (under items 5, 6, 7 and 8) or that contain an already approved active but require specific assessment (under item 10).
Like all applications, those which nominate a reference product need to pass through preliminary assessment, following which the APVMA assesses whether the application meets the statutory criteria relating to safety, efficacy and trade.?
To ensure applications can be processed as quickly as possible, applicants are advised to include all relevant information when they lodge their application.
Where there is incomplete information, the APVMA will issue notices to applicants (under section 159 of the Agvet Code), or seek information/submissions (under section 8C of the Agvet Code) to obtain the required information.
A common area where the APVMA has to seek additional information is to obtain product specifications and test methods for veterinary medicine products that are closely similar to registered products and assessed under item 7.?Provision of specifications and test methods with the initial application will reduce the need for the APVMA to seek this information.
Some applications seek to rely on data in relation to a reference product which the APVMA is legislatively prevented from using—commonly known as limits on use data. The APVMA is unable to finalise these applications in the absence of other substantiating data unless consent from the authorising party to access this data is provided.
Applicants can check if a proposed reference product has limits on use of any data before submitting the application. This is on the APVMA website under the ‘Protected’ tab for the reference product in PubCRIS. If you are unsure about this, please check with the APVMA prior to lodging your application.
The APVMA may consider that an application needs to be re-categorised if it would fit more appropriately under a different item in Schedule 6, Part 2 of the Regulations and more accurately reflect the assessment that is required to satisfy the safety, efficacy and trade requirements. In these circumstances, the APVMA will provide affected applicants with a proposal to re-categorise. The applicant will have 14 days to respond to the proposal prior to a final decision being made to re-categorise.
Where there are no other issues to be addressed, the APVMA will progress and finalise assessment of the application. Through this process the APVMA will consider whether its notice of decision could lead to an unauthorised disclosure of CCI, which is something that has to be assessed on a case by case basis.