This content is current only at the time of printing. This document was printed on 15 December 2018. A current copy is located at https://apvma.gov.au/taxonomy/term/18071
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I want to vary a withholding period and/or export interval
An application to vary a withholding period and/or export interval statement must contain sufficient information to demonstrate that the proposed label changes will:
(i) not result in an exceedance of established maximum residue limits (MRLs), or
(ii) support any proposed changes to MRLs.
The product, once varied as proposed, must continue to meet the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria.
Applications to vary withholding period and/or export interval details for registered products may be made via:
- Item 14 – Technical modular application—requiring submission of new residues data
- Item 12 – No data of a technical nature is required—this type of application is used where the risks for proposed amendment to the withholding period/export interval are consistent with a reference product not subject to data protection.
Is a technical assessment required for my proposed variation?
For a variation to be processed without a technical assessment (Item 12), all risk areas must be supported by solely referencing another registered product (reference product). Applicants seeking to rely on a reference product should explain the reasons why the reference product supports the variation. This should include how the risks are equivalent between the two products including:
- similarity in instructions for use (crops, species, situations, claims, rate/dose, method of application/route of administration)
- the active constituent and its concentration
- the formulation type.
Limits of use (data protection): Where there are limits of use of information on the reference product written consent from the authorising party is required when access to the information is necessary to determine the application.
Where the reference product does not fully support all risk areas or the product is subject to Limits of use and additional data is being provided to satisfy the safety, efficacy or trade criteria these applications should be lodged as Item 14 applications.