Medicines and Poisons Act 2019

Before the emerging risk declaration ends, the chief executive may renew the declaration by publishing a notice on the department’s website.

However, subsection (1) applies only if the chief executive believes—

more time is needed to allow—

the substance stated in the declaration to be prescribed under section 11, 12 or 13 as a medicine, poison or prohibited substance; or

the substance stated in the declaration to be considered under the Therapeutic Goods Act 1989 (Cwlth) for listing in the Poisons Standard; or

the device stated in the declaration to be registered as a medical device under the Therapeutic Goods Act 1989 (Cwlth); and

the substance, or use of the substance with a device, should in the meantime continue to be regulated under this Act to prevent or minimise a health risk.

In renewing the emerging risk declaration, the chief executive may decide to change any matter stated in the declaration if the chief executive considers the change is reasonably necessary.

The notice for the renewal must state the following matters—

the emerging risk declaration to which the renewal applies;

the day, no later than 3 months after the day on which the renewal notice is published, on which the declaration ends;

if the chief executive decides to change a matter stated in the declaration—a brief statement of the change and the reasons for the change.

The renewal takes effect on the day the emerging risk declaration would, but for the renewal, end.

The chief executive must take reasonable steps to ensure persons likely to be directly affected by the renewal of the emerging risk declaration are made aware of the renewal.

The renewal of the emerging risk declaration is not invalid only because of a failure of the chief executive to comply with subsection (6).