Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 10C

Re-assignment of registration or listing numbers

         (1)   A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.

         (2)   An application:

                (a)    must be made in writing to the Secretary and delivered to an office of the Department; and

               (b)    must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and

                (c)    may contain a nomination referred to in subparagraph (6) (b) (ii).

         (3)   The Secretary may assign to therapeutic goods that:

                (a)    were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and

               (b)    are not grouped therapeutic goods when:

                          (i)    the application is decided; or

                         (ii)    an order is made under section 16 of the Act in relation to the goods;

a registration or listing number that is not assigned to other therapeutic goods or grouped therapeutic goods.

         (4)   The Secretary must assign to grouped therapeutic goods that:

                (a)    were in a gazetted therapeutic devices group or a gazetted therapeutic goods group when a registration or listing number was assigned, or last assigned, to the goods; and

               (b)    are in a gazetted therapeutic devices group, or a gazetted therapeutic goods group, other than a group referred to in paragraph (a), when:

                          (i)    the application is decided; or

                         (ii)    an order is made under section 16 of the Act in relation to the goods;

a registration or listing number that is not assigned to other therapeutic goods or grouped therapeutic goods.

         (5)   The Secretary must assign to therapeutic goods that:

                (a)    were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and

               (b)    are grouped therapeutic goods when:

                          (i)    the application is decided; or

                         (ii)    an order is made under section 16 of the Act in relation to the goods;

a registration or listing number in accordance with subregulation (6).

         (6)   The Secretary:

                (a)    may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and

               (b)    must assign to those goods a registration or listing number that:

                          (i)    was assigned, or last assigned, to the goods; and

                         (ii)    is nominated by the person in whose name the goods are registered or listed;

not being a registration or listing number that is assigned to other therapeutic goods or grouped therapeutic goods.



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