This content is current only at the time of printing. This document was printed on 23 June 2021. A current copy is located at http://www.plural-consulting.com/node/20071
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Primary and secondary applications
Applicants sometimes apply to register or vary a suite of agvet chemical products containing the same chemical in different concentrations. Examples include products with the same active constituent but different formulation types (granule, powder and concentrate) or a product range for large, medium and small dogs.
Applicants can nominate an application (a secondary application) as a related application to another application (the primary application).
The data supplied with these applications can be assessed once with the primary application and not reassessed for the secondary applications, noting that the secondary applications may contain data/information that is specific to that product. Application fees are proportionate to the assessment effort required. In circumstances where a secondary application relies on data and assessment of the primary application, the secondary application fees will be reduced and timeframes for assessments aligned.
Primary and secondary product applications must be from the same applicant, contain the same active constituent and be manufactured at the same address. The primary and secondary applications must also be made under the same section of the Agvet Code; under section 10 (new product) or section 27 (variation). Primary and secondary applications must be lodged on the same day to ensure the applications are processed together and fees and timeframes can be considered promptly upon lodgement.
Applying for primary and secondary applications
Applications must be made through the Online services portal.
Applicants are advised to use the ‘related applications’ field on each application form to reference the primary application decision identification number on all related secondary applications. This will enable the APVMA to link the applications when submitted. The primary application will be the product application that contains the largest amount (dosage) of the active constituent.
When lodging primary and secondary applications, the same modules should be selected for the primary application as well as on each of the secondary applications. This will ensure the primary and secondary application timeframes are aligned. Where secondary application fees will be reduced, a fee waiver will be applied.
It is recommended that applicants always seek pre-application assistance for these applications to ensure a common understanding of the requirements for assessment and the applications that are to be considered as part of the primary/secondary arrangements.
Approach to assessing primary and secondary applications
The APVMA’s approach to assessing related primary and secondary applications will where possible ensure that:
- the APVMA’s assessment of the secondary product applications relies, as far as is possible, on its assessment of the primary application
- the fees paid for the secondary product applications reflect the reduced level of assessment required for those applications (given the APVMA’s reliance on its assessment of the primary application). The notice issued by the APVMA to the applicant under section 11(2) of the Agvet Code following preliminary assessment, will provide for the waiver of any fees
- the applications are finalised at the same time. If the APVMA decides to issue a notice to the applicant, for the primary application under section 159 (requiring additional information or other things) of the Agvet Code this will also apply to any secondary applications. This will mean that the same assessment periods continue to apply for each of the applications so they can be finalised together.