Providing label and information about label to APVMA
18I Providing label and information about label to APVMA
The holder of the approval of the label must, on a written request by the APVMA for:
a copy of a form of the label mentioned in paragraph 18H(1)(a); and
information about the label mentioned in paragraphs 18H(1)(b) and (c);
provide the label and information requested to the APVMA.
If the request is for a copy of a form of a label, the copy must be accompanied by a declaration that the copy is of a form of label that has been attached to a container to which it relates.
The label and information must be provided to the APVMA on the earlier of the following:
within 10 days of the day on which the request for the label and information is received;
on a day advised by the APVMA.
The APVMA must not advise a date for paragraph (3)(b) unless:
the APVMA believes it is necessary to receive the label or information before the end of the period mentioned in paragraph (3)(a) to prevent imminent risk to persons of death, serious illness or serious injury; and
the APVMA provides the reasons for the early date in the written request.
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