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THERAPEUTIC GOODS ACT 1989 - SECT 23C

Requirements relating to applications for listing of therapeutic goods under section 26 or 26A

             (1)  This section applies if an application is made under section 23 for listing of therapeutic goods under section 26 or 26A.

             (2)  The application complies with this section if:

                     (a)  the application is made in accordance with a form approved, in writing, by the Secretary or in such other manner as is approved, in writing, by the Secretary for the purposes of this paragraph; and

                     (b)  the application is delivered to an office of the Department specified by the Secretary; and

                     (c)  the prescribed application fee has been paid; and

                     (d)  the applicant has delivered to the office to which the application was made such information, in a form approved, in writing, by the Secretary, as will allow the determination of the application; and

                     (e)  if the Secretary so requires--the applicant has delivered to the office to which the application was made a reasonable number of samples of the goods ; and

                      (f)  if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)--the application is accompanied by a statement from the applicant certifying that:

                              (i)  if those prohibitions cover imports--any imports into Australia of the goods by, or on behalf of the applicant, will not contravene those prohibitions; and

                             (ii)  if those prohibitions cover exports--any exports from Australia of the goods by, or on behalf of the applicant, will not contravene those prohibitions; and

                            (iii)  if those prohibitions cover supplies--any supplies in Australia of the goods by, or on behalf of the applicant, will not contravene those prohibitions; and

                     (g)  if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions--the application is accompanied by a statement from the applicant certifying that:

                              (i)  if those prohibitions cover imports--any imports into Australia of the goods by, or on behalf of the applicant, will not contravene those conditions; and

                             (ii)  if those prohibitions cover exports--any exports from Australia of the goods by, or on behalf of the applicant, will not contravene those conditions; and

                            (iii)  if those prohibitions cover supplies--any supplies in Australia of the goods by, or on behalf of the applicant, will not contravene those conditions.

Note:          To be listed, an application must comply with this section: see sections 26, 26A and 26AB.

             (3)  The Secretary may, by legislative instrument, determine forms of information for the purposes of the application of paragraph (2)(d).

             (4)  An approval of a form may require or permit an application or information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.



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