Therapeutic Goods Act 1989

Where:

an application is made for the listing of therapeutic goods in relation to a person under section 23; and

the application complies with section 23C; and

the application is accompanied by either:

the certificate required under subsection 26B(1); or

a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application; and

the person has complied with any requirements made by the Secretary under section 31 in relation to the goods; and

the goods are not goods which may be listed under section 26A or 26AE;

the goods are not eligible for listing; or

the goods are not safe for the purposes for which they are to be used; or

the presentation of the goods is unacceptable; or

the goods do not conform to a standard applicable to the goods; or

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

an applicable provision of the Therapeutic Goods Advertising Code;

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

if a step in the manufacture of the goods has been carried out outside Australia—the manufacturing and quality control procedures used in the manufacture of the goods are not acceptable; or

if the goods have been manufactured in Australia—the goods have been manufactured contrary to Part 3‑3; or

if the goods have been manufactured in Australia, or imported into Australia, solely for export—a relevant authority of the country to which the goods are to be exported has not confirmed its willingness to accept the goods and:

the goods have been refused registration or listing for supply in Australia; or

the Secretary requires such a confirmation for a reason other than because the goods have been refused registration or listing; or

the goods do not comply with prescribed quality or safety criteria; or

if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)—imports into Australia, exports from Australia or supplies in Australia of the goods would contravene one or more of those prohibitions; or

if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions—imports into Australia, exports from Australia or supplies in Australia of the goods would contravene one or more of those conditions; or

the goods contain substances that are prohibited imports for the purposes of the Customs Act 1901; or

one or more of the manufacturers of the goods are not nominated as manufacturers of the goods in the application.

If:

a medicine (the original medicine) is included in the Register in relation to a person; and

the person makes an application under section 23 for the listing of a medicine (the new medicine) under this section; and

the application complies with section 23C; and

the Secretary is satisfied that paragraphs (1)(a) to (ba) are satisfied in relation to the application; and

the Secretary is satisfied that the new medicine has the same characteristics as the original medicine apart from the characteristics specified in an instrument under subsection (1AB);

The Minister may, by legislative instrument, specify characteristics for the purposes of paragraph (1AA)(d).

To avoid doubt, if:

an application is made for the listing of therapeutic goods in relation to a person under section 23; and

the application complies with section 23C; and

the application is accompanied by either:

the certificate required under subsection 26B(1); or

a notice that a certificate under that subsection is not required in relation to the application; and

the other requirements in subsection (1) are met;

In making a decision for the purposes of paragraph (1)(g), the matters that may be taken into account include:

whether the applicant has provided:

if a step in the manufacture of the goods 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 goods; or

if a step in the manufacture of the goods 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 goods; or

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

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

funds for the carrying out of that inspection by the Department; and

evidence that the manufacturer has agreed to such an inspection.

If therapeutic goods are exempt from the operation of Part 3‑3 or a person is exempt from the operation of that Part in relation to the manufacture of the goods, subsection (1) has effect, in relation to the goods, as if paragraph (h) were omitted.

If a person is exempt from the operation of Part 3‑3 in relation to a step in the manufacture of therapeutic goods, subsection (1) has effect, in relation to the goods, as if the reference in paragraph (h) to Part 3‑3 were a reference to that Part to the extent that it applies to that person in relation to the manufacture of the goods.

If:

therapeutic goods were made outside Australia; and

had the goods been made in Australia, they would have been exempt from the operation of Part 3‑3;

A decision for the purposes of paragraph (1)(g) may also take into account any information provided to the Secretary by a health authority of a Convention country and relating to:

the general standards of manufacturing practice of a particular manufacturer; or

the specific standards of manufacture or control adopted by a particular manufacturer in relation to particular goods.

For the purposes of subsection (2D), a Convention country is a country that is a party to the Mutual Recognition Convention.

Information referred to in subsection (2D) and provided in accordance with the Mutual Recognition Convention is to be treated as equivalent to information obtained as a result of an inspection under Part 3‑3 of this Act.

Where an application is made, the Secretary must notify the applicant in writing of his or her decision on the application within 28 days of the making of the decision and, in the case of a decision not to list the goods, of the reasons for the decision.

As soon as practicable after an applicant has been informed that therapeutic goods in respect of which an application was made are acceptable for listing, the Secretary must give to the applicant a certificate of listing of the goods, and the listing of the goods commences on the day specified for the purpose in the certificate.