APVMA may vary on its own initiative with holder’s consent
29A APVMA may vary on its own initiative with holder’s consent
The APVMA may, on its own initiative, and with the written consent of the holder, vary the relevant particulars or conditions of an approval or registration.
The APVMA may only vary relevant particulars or conditions that it has imposed. See section 6B.
For notice of variation, see section 8F.
The APVMA may vary the relevant particulars or conditions only if it is satisfied:
for an active constituent—that, if those particulars or conditions were so varied, the constituent would meet the safety criteria; and
for a chemical product—that, if those particulars or conditions were so varied, 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—that, if those particulars or conditions were so varied, the label would:
meet the labelling criteria; or
comply with the established standard for the product; and
that the constituent, product or label complies, or will comply, with any requirement prescribed by the regulations.
No fee is payable in relation to a variation made under this section.
Nothing in this Code requires the APVMA to make a variation under this section.
The statute text is free to read above. View Pro plans to unlock the case-law research tools for each provision.