Notice of notifiable variations
26AB Notice of notifiable variations
The holder may, in writing, lodge notice with the APVMA of one or more notifiable variations of the relevant particulars of an approval or registration.
The notice must meet the notice requirements.
For meets the notice requirements, see subsection 26AD(1).
A notifiable variation is a variation of a kind that:
either:
is determined by the APVMA under subsection (5); or
is prescribed by the regulations; and
is not a prescribed variation under Division 2A.
The APVMA must not determine a kind of variation under subsection (5) unless it is satisfied that, with the relevant particulars so varied:
for an active constituent—the constituent would meet the safety criteria; and
for a chemical product—the product would:
meet the safety criteria, the trade criteria and the efficacy criteria; or
comply with the established standard for the product; and
for a label for a chemical product—the label would:
meet the labelling criteria; or
comply with the established standard for the product.
The APVMA may, by legislative instrument, determine a kind of variation for the purposes of subparagraph (3)(a)(i).
If the notice does not meet the notice requirements, the APVMA must:
notify the holder in writing of that fact; and
include in the notice the reasons why the holder’s notice does not meet the notice requirements.
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