Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 31

             (1)  The Secretary may, by notice in writing given to a person who is an applicant for the registration of therapeutic goods or in relation to whom therapeutic goods are registered, require the person to give to the Secretary, within such reasonable time as is specified in the notice and in such form as is specified in the notice, information or documents relating to one or more of the following:

                     (a)  the formulation of the goods;

                     (b)  the composition of the goods;

                     (c)  the design specifications of the goods;

                     (d)  the quality of the goods;

                     (e)  the method and place of manufacture or preparation of the goods and the procedures employed to ensure that proper standards are maintained in the manufacture and handling of the goods;

                      (f)  the presentation of the goods;

                     (g)  the safety and efficacy of the goods for the purposes for which they are to be used;

                     (h)  the conformity of the goods to a requirement relating to advertising applicable under Part 5‑1 or under the regulations;

                      (j)  the regulatory history of the goods in another country;

                     (k)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind.

             (2)  The Secretary may, by notice in writing given to a person who is an applicant for the listing of therapeutic goods or in relation to whom therapeutic goods are listed, require the person to give to the Secretary, within such reasonable time as is specified in the notice, information or documents relating to one or more of the following:

                     (a)  the formulation of the goods;

                     (b)  the composition of the goods;

                     (c)  the design specifications of the goods;

                     (d)  the method and place of manufacture or preparation of the goods and the procedures employed to ensure that proper standards are maintained in the manufacture and handling of the goods;

                     (e)  the presentation of the goods;

                      (f)  the safety of the goods for the purposes for which they are to be used;

                     (g)  the conformity of the goods to a standard applicable to the goods, or to a requirement relating to advertising applicable to the goods under Part 5‑1 or under the regulations;

                     (h)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind.

             (3)  An approval of a form may require or permit 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.

             (4)  A person in relation to whom therapeutic goods are registered or listed must not fail to comply with a notice given to the person under this section.

Penalty:  500 penalty units.

          (4A)  Subsection (4) does not apply if the person has a reasonable excuse.

Note:          The defendant bears an evidential burden in relation to the matter in subsection (4A). See subsection 13.3(3) of the Criminal Code .

             (5)  An offence under subsection (4) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code .

          (5A)  A person commits an offence if:

                     (a)  a medicine is listed under section 26A in relation to the person; and

                     (b)  the person provides information in purported compliance with a notice under section 31 relating to the medicine; and

                     (c)  the information is false or misleading in a material particular; and

                     (d)  either:

                              (i)  the use of the medicine has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the medicine, if the medicine were used, would result in harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (6) instead: see section 53A.

          (5B)  A person commits an offence if:

                     (a)  a medicine is listed under section 26A in relation to the person; and

                     (b)  the person provides information in purported compliance with a notice under section 31 relating to the medicine; and

                     (c)  the information is false or misleading in a material particular; and

                     (d)  the use of the medicine, if the medicine were used, would be likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

          (5C)  Subsection (5B) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code .

             (6)  A person in relation to whom a medicine is listed under section 26A must not, in purported compliance with a notice under this section relating to the medicine, provide information that is false or misleading in a material particular.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.