means premises:

means an authorisation referred to in subsection 38(2B) or 40B(4).

has the meaning given by section 41BD.

means a classification specified in the regulations made for the purposes of section 41DB.

, in relation to a kind of medical device, means a medical device standard, specified in an order under section 41CB, that is applicable to that kind of medical device.

means therapeutic goods (other than biologicals) that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human.

means a country declared by the Minister under section 3A to be a member of the European Free Trade Association.

means a country declared by the Minister under section 3A to be a member of the European Community.

means any of the following:

means the Convention for the Mutual Recognition of Inspections in respect of the Manufacture of Pharmaceutical Products done at Geneva on 8 October 1970.

has the same meaning as in the National Emergency Declaration Act 2020.

, for a non ‐ EC/EFTA MRA, means an attestation of conformity issued, after the non ‐ EC/EFTA MRA has come into force, by a conformity assessment body that is designated in the non ‐ EC/EFTA MRA and approved by the Secretary in writing for the non ‐ EC/EFTA MRA.

means an international instrument that Australia is bound by, or is a party to, if:

includes affirmation.

, in relation to premises, includes a person present at the premises who is in apparent control of the premises.

has the meaning given by section 41BIB.

means a certificate or other document that is issued by an overseas regulator after that regulator is satisfied that requirements, comparable to the conformity assessment procedures, have been applied to a medical device by the manufacturer of the device.

:

of a shortage of a medicine in Australia has the meaning given by section 30EIA.

means an ingredient, compound, material or preparation which, or the use of which, may cause death, illness or injury and includes any ingredient, compound, material or preparation referred to in a schedule to the current Poisons Standard.