Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:
(a) if the goods become subject to inclusion in the part of the Register for registered goods--to the part of the Register for registered goods; or
(b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act--to the part of the Register for biologicals.
(2) 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 for 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.
(3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.
(4) If goods that are included in the Register under Part 3 - 2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:
(a) listed goods; or
(b) registered goods; or
(c) medical devices.
(5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.
(6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:
(a) are included in the Register as a medical device under Chapter 4 of the Act; and
(b) cease to be a medical device because of a declaration under subsection 41BD(3) of the Act; and
(c) are a biological.
(7) An application under subregulation (1), (3), (4) or (6) 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--within 15 months after the day when the goods:
(i) became subject to inclusion in the part of the Register for registered goods; or
(ii) were specified by the Secretary to be a biological under subsection 32A(2) of the Act.
(8) An offence under subregulation (7) is an offence of strict liability.
Note: For strict liability , see section 6.1 of the Criminal Code .
(9) In determining a period of notice for paragraph (7)(a), the Secretary must consider:
(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.
(10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3 - 2A of the Act until the later of:
(a) expiry of the time for making the application under subregulation (7); or
(b) if an application is made--when the application is determined.
(11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.