Document ID: chunk:federal_register_of_legislation:C2024C00632:section:3:p8
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 3 (pt 8/14)
Character Range: 39130–41962

if:
 (a) a purpose of the instrument is the recognition of attestations of conformity; and
 (b) the instrument satisfies the requirements (if any) set out in regulations made for the purposes of this paragraph;
but does not include:
 (c) the EC Mutual Recognition Agreement; or
 (d) the EFTA Mutual Recognition Agreement.
nurse practitioner means a person who is registered, or authorised (however described) to practise, as a nurse practitioner by or under a law of a State or an internal Territory that provides for the registration of nurse practitioners, or the authorisation of persons to practise as nurse practitioners.
oath includes affirmation.
overseas regulator has the meaning given by section 41BIB.
overseas regulator conformity assessment document 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.
passed preliminary assessment:
 (a) when used in relation to a section 23 application for registration—has the meaning given by subsection 23B(3); and
 (b) when used in relation to a section 23 application for listing under section 26AE—has the meaning given by subsection 23B(3); and
 (ba) when used in relation to a section 26BD application—has the meaning given by subsection 26BD(4); and
 (c) when used in relation to a section 32DD application—has the meaning given by subsection 32DDA(3); and
 (d) when used in relation to a section 41FC application—has the meaning given by subsection 41FDB(3).
period of a shortage of a medicine in Australia has the meaning given by section 30EIA.
personal information has the same meaning as in the Privacy Act 1988.
pharmacist means a person who is registered as a pharmacist under a law of a State or an internal Territory that provides for the registration of pharmacists.
poison 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.
premises includes:
 (a) a structure, building, aircraft, vehicle or vessel; and
 (b) a place (whether enclosed or built upon or not); and
 (c) a part of a thing referred to in paragraph (a) or (b).
presentation, in relation to therapeutic goods, means the way in which the goods are presented for supply, and includes matters relating to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods.
primary pack, in relation to therapeutic goods, means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers.
product