Therapeutic Goods Act 1989

The Secretary may, by written notice given to a person:

who is an applicant for the inclusion of a biological in the Register; or

in relation to whom a biological is included in the Register; or

in relation to whom a biological was, at any time during the previous 5 years, included in the Register;

the formulation of the biological;

the composition of the biological;

the design specifications of the biological;

the quality of the biological;

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

the presentation of the biological;

the safety and efficacy of the biological for the purposes for which it is to be used;

whether the biological conforms with a standard applicable to it;

whether the biological complies with conditions (if any) on the inclusion of the biological in the Register;

whether either of the following has not been complied with in relation to the biological:

an applicable provision of the Therapeutic Goods Advertising Code;

any other requirement relating to advertising applicable under Part 5‑1 or under the regulations;

if the biological is included in the Register in relation to the person—whether the biological is being:

supplied in Australia; or

imported into Australia; or

exported from Australia;

if the biological is included in the Register in relation to the person and there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)—whether any supplies in Australia, any imports into Australia or any exports from Australia of the biological contravene those prohibitions;

if the biological is included in the Register in relation to the person and there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions—whether any supplies in Australia, any imports into Australia or any exports from Australia of the biological contravene those conditions;

the regulatory history of the biological in another country;

any other matter prescribed by the regulations for the purposes of this paragraph in relation to a biological of that kind.

The person must give the information, or produce the documents, to the Secretary:

within the period, of not less than 14 days after the day the notice is given, specified in the notice; and

in the form specified in the notice.

Section 32JB contains criminal offences for failing to comply with the notice and for giving false or misleading information or documents and section 32JC contains a civil penalty for giving false or misleading information or documents.

The form may require or permit the information to be given, or the documents to be produced, in accordance with specified software requirements:

on a specified kind of data processing device; or

by way of a specified kind of electronic transmission.

If a notice is given under subsection (1) to a person covered by paragraph (1)(c), then paragraphs (1)(d) to (p) (to the extent to which they are relevant) apply in relation to that part of the period of 5 years before the notice was given during which the biological was included in the Register.