Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) If goods (other than medical devices) that are included in the part of the Register for listed goods become subject to inclusion in the part of the Register for registered goods, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry in relation to the goods to the part of the Register for registered goods.
(2) An application under subregulation (1) must be made:
(a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made -- within that period; or
(b) in any other case -- not later than 15 months after the day on which the goods became subject to inclusion in the part of the Register for registered goods.
Penalty: 5 penalty units.
(2A) An offence under subregulation (2) is an offence of strict liability.
Note For strict liability , see section 6.1 of the Criminal Code .
(3) In determining a period of notice for the purposes of paragraph (2) (a) the Secretary is to have regard to:
(a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and
(b) the reasons for the transfer in relation to the protection of the public.
(4) It is not an offence for the sponsor of goods to which subregulation (1) applies to import, export, supply or manufacture the goods as listed goods until the time for making the application under subregulation (2) has expired or, if an application is made, until it is determined, whichever is the later.
(5) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:
(a) to transfer the entry in relation to the goods to the part of the Register for listed goods; or
(b) to retain the entry in the part of the Register for registered goods.
(6) If:
(a) goods are included in the Register under Chapter 4 as a kind of medical device; and
(b) the goods cease to be a medical device because of a declaration under subsection 41BD (3) of the Act;
the person in relation to whom the kind of device is included in the Register may apply to the Secretary to transfer the entry in relation to the goods to the part of the Register for registered goods or the part of the Register for listed goods, as the case requires.
(7) An application to transfer an entry in relation to goods from a part of the Register to the part of the Register for registered goods, or the part of the Register for listed goods, is to be treated as an application for registration or listing of the goods, as the case requires.