THERAPEUTIC GOODS ACT 1989 - SECT 32DA Application for inclusion in the Register

THERAPEUTIC GOODS ACT 1989 - SECT 32DA

  (1)   A person may make an application to the Secretary to include a Class 1 biological in the Register.

  (2)   An application must:

  (a)   be made in accordance with a form that is approved, in writing, by the Secretary; and

  (b)   be accompanied by a statement certifying the matters mentioned in subsection   (3); and

  (c)   be delivered to an office of the Department specified in the form; and

  (d)   be accompanied by the prescribed application fee.

  (3)   The applicant must certify that:

  (a)   the biological is a Class 1 biological; and

  (b)   the biological is safe for the purposes for which it is to be used; and

  (c)   the biological conforms to every standard (if any) applicable to it; and

  (d)   both of the following are complied with in relation to the biological:

  (i)   the applicable provisions of the Therapeutic Goods Advertising Code;

  (ii)   the other requirements (if any) relating to advertising applicable under Part   5 - 1 or under the regulations; and

  (e)   the biological complies with all prescribed quality or safety criteria that are applicable to it; and

  (f)   the biological does not contain substances that are prohibited imports for the purposes of the Customs Act 1901 ; and

  (g)   if there are one or more absolute prohibitions in force for the purposes of subsection   9K(1) or (3):

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

  (h)   if there are one or more prohibitions in force for the purposes of subsection   9K(1) or (3) that are subject to conditions:

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

  (4)   An approval of a form may require or permit an application 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.