Therapeutic Goods Act 1989

A person may make an application to the Secretary to include an export only biological in the Register.

The application must:

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

be accompanied by a statement made by the applicant certifying the matters mentioned in subsection (4); and

be accompanied by the fee prescribed by regulations made for the purposes of this paragraph.

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

on a specified kind of data processing device; or

by way of a specified kind of electronic transmission.

The matters the applicant must certify are:

that the biological is an export only biological; and

that the biological is safe for the purposes for which it is to be used; and

that the presentation of the biological is not unacceptable; and

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

that the requirements (if any) relating to advertising applicable under Part 5‑1 or under the regulations are complied with in relation to the biological; and

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

that all the manufacturers of the biological are nominated as manufacturers in the application; and

if a step in the manufacture of the biological has been carried out in Australia—that the biological is exempt from the operation of Part 3‑3 or that the step has been carried out by a person who:

is the holder of a licence to carry out that step; or

is exempt from the operation of that Part in relation to that step; and

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

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

if those prohibitions cover imports—that any imports into Australia of the biological by, or on behalf of the applicant, will not contravene those prohibitions; and

if those prohibitions cover exports—that any exports from Australia of the biological by, or on behalf of the applicant, will not contravene those prohibitions; and

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

if those prohibitions cover imports—that any imports into Australia of the biological by, or on behalf of the applicant, will not contravene those conditions; and

if those prohibitions cover exports—that any exports from Australia of the biological by, or on behalf of the applicant, will not contravene those conditions; and

any other matter prescribed by regulations made for the purposes of this paragraph.

Subject to subsection (7), if one or more steps in the manufacture of the biological have been carried out outside Australia, the Secretary must certify, or refuse to certify, that the manufacturing and quality control procedures used in each such step are acceptable.

See also subsections 32EA(5), (7A) and (7B) and section 32EB in relation to conditions and certifications for the manufacture of a biological outside Australia after the biological is included in the Register.

In deciding whether so to certify for the purposes of subsection (5), the matters that may be taken into account include:

whether the applicant has provided:

if a step in the manufacture of the biological has been carried out in a country that is a member of the European Community or a member of EFTA—an EC/EFTA attestation of conformity in relation to the biological; or

if a step in the manufacture of the biological has been carried out in a country declared by the Minister under section 3B to be covered by a non‑EC/EFTA MRA—a non‑EC/EFTA attestation of conformity, for the non‑EC/EFTA MRA, in relation to the biological; or

in any other case—an acceptable form of evidence from a relevant overseas authority establishing that the manufacture of the biological is of an acceptable standard; and

whether the applicant has agreed to provide, if the Secretary considers inspection of the manufacturing procedures used in the manufacture of the biological to be necessary:

funds for the carrying out of that inspection by, or on behalf of, the Secretary; and

evidence that the manufacturer has agreed to such an inspection; and

whether the applicant has complied with any requirements made by the Secretary under section 32JA in relation to the manufacture of the biological.

If:

one or more steps in the manufacture of the biological have been carried out outside Australia; and

had the biological been manufactured in Australia, it would have been exempt from the operation of Part 3‑3 because of the operation of subsection 34(1);