Importation into Australia of therapeutic goods for human use is controlled under the *Therapeutic Goods Act 1989 (Therapeutic Goods Act), the Therapeutic Goods Regulations 1990 (Therapeutic Regulations), and the Customs (Prohibited Imports) Regulations 1956 (PI Regulations).

Under the Therapeutic Goods Act, therapeutic goods may not be imported into Australia unless they are registered, listed or included in the Australian Register of Therapeutic Goods (ARTG) or specifically exempt from this requirement. One exemption is for personal importation of therapeutic goods. Under Schedule 5 of the Therapeutic Regulations, an individual may import a therapeutic good into Australia on their person, or arrange from within Australia for a therapeutic good to be sent to them from an overseas supplier, subject to the following:

• the goods are to be used by that individual or a member of his/her immediate family and are not sold or supplied to any other person;
• the quantity imported may not exceed three months' supply per importation and the total quantity imported per year cannot exceed 15 months' supply at the manufacturer's recommended maximum dosage;
• substances, which are a prohibited import under the PI Regulations, may not be imported without an import permit;
• products which are injections containing material of human or animal origin (except insulin) may not be imported as personal imports, without permission from the Therapeutic Goods Administration;
• products which are "biologicals", as defined under the Therapeutic Goods Act , may not be imported as personal imports, without permission from the Therapeutic Goods Administration; and
• in order to import any product which is a prescription medicine (substances in Schedules 4 or 8 of the Standard for the Uniform Scheduling of Medicines and Poisons), the importer must have a prescription issued by a medical practitioner registered in an Australian state or territory (Note: medicines carried by a passenger on a plane or ship are an exception to this requirement, however, an import licence is still required in the case of medicines in Schedule 4 of the PI Regulations if the passenger does not have a prescription).

Importation of certain substances is prohibited under regulations 5, 5G and 5H of the PI Regulations except with the permission of the Secretary of the Department of Health and Aged Care. These substances include antibiotics, certain hormones and other substances, including anabolic or androgenic substances (included in Schedules 7A of the PI Regulations). Substances of human or animal origin are not prohibited imports per se.

Importation of narcotic drugs, psychotropic substances and related chemicals, including kava, is also controlled under the PI Regulations. Those controls are described separately in this document, in the section entitled "Narcotic Drugs, Psychotropic Substances and Related Chemicals".

Import permits are issued under the PI Regulations both for goods approved for marketing in Australia and for "unapproved" goods where supply is considered appropriate (e.g. in the context of clinical trials or special patient access). The therapeutic substances/goods covered are:

• goods to which regulation 5G of the PI Regulations refer, that is, goods, which are, listed in Schedule 7A to the Regulations. Schedule 7A currently lists therapeutic goods which are mostly, hormones. Exemption applies where:
  • the substance is required for the medical treatment of a person who is a passenger on a ship or aircraft;
  • the substance is imported into Australia on the ship or aircraft;
  • the substance was prescribed by a medical practitioner for that treatment; and
  • the amount of the substance imported does not exceed the amount of the substance prescribed by the medical practitioner for the person receiving the treatment.

However, the above exemption does not apply if the goods are required for the medical treatment of a person who is an athlete within the meaning of section 4 of the Australian Sports Anti-Doping Authority Act 2006; or a person who has come to Australia for purposes relating to the performance of a competitor or the management of a competitor or a competitor's interest.

The regulation applies to the importation of therapeutic goods from all countries.

The controls under the Therapeutic Goods Act safeguard public health in Australia through regulation of the quality, safety and efficacy or performance of therapeutic goods intended for supply in Australia.

The controls under the PI Regulations are intended to restrict entry to Australia of substances that may be the subject of abuse in one form or another, or pose a risk to public health such that they should not be accessible to the general public via personal import arrangements. The importation of antibiotics is regulated as a public health measure. It also allows information on the distribution and consumption of antibiotics in Australia to be obtained. Goods listed in Schedules 7A and 8 to the PI Regulations are those known to be associated with particular hazards or concerns, which warrant restriction or prohibition of their use. The PI Regulations are not intended to restrict the quantity or volume of imports.

The controls on importation of therapeutic goods are statutory requirements under the Therapeutic Goods Act, and Therapeutic Regulations, and under the Customs Act 1901, and associated PI Regulations. The system cannot be abolished without legislative approval.

Application for importation should be made in advance of the arrival of the goods. In certain circumstances, import permission can be given for goods which have inadvertently arrived at the point of entry.

Permits may be issued immediately if a genuine emergency exists.

Permits may be issued at any period of the year.

Applications for import permits under regulations 5, 5G and 5H of the PI Regulations are processed and issued within the Department of Health and Aged Care.

If an import permit under regulations 5, 5G or 5H of the PI Regulations is refused, the applicant is notified in writing of the reasons for refusal. A request for review of the refusal can be made to the Australian Government Minister who administers the Therapeutic Goods Act, within 90 days after the decision first comes into the importer's notice. In the case of the applicant being dissatisfied with the Minister's finding, an application for a review of the Minister's decision can be made to the Administrative Appeals Tribunal. In addition, an appeal may be made on the decision-making process itself under the Administrative Decisions (Judicial Review) Act 1977.

All persons, firms and institutions are eligible to apply for permission to import provided they are domiciled in Australia. They must also comply with any state/territory legislation relating to manufacture and wholesale.

For permission to import goods specified in Schedule 8 (Regulation 5H of the PI Regulations) the written application must include:

• importer's name and address;
• full details of the product proposed for import;
• supervising doctor's prescription, if applicable;
• state/territory Schedule 4 (prescription only medicine) licence number (if applicable); and
• depending on the nature of the goods and the intended purposes, further documentation or evidence may be required.

Import authorisation is usually issued in the form of a permit, but may be by letter of authority.

There is no licensing fee or administrative charge.

There is no deposit or advance payment requirement associated with the issue of licences.

Import permits may apply to one consignment only, or remain valid for successive consignments within a stated period (usually one year).

There is no penalty for the non-utilisation of a permit or a portion of a permit.

Permits are not transferable between importers.

Permits issued for substances in Schedules 7A and Schedule 8 of the PI Regulations are subject to individual quantitative restrictions. However, there is no annual quota or annual quantitative restrictions applicable to these goods required under the legislation or under an international agreement.

The quantitative restriction applies to individual importers as a condition of the import permit and is based on established need and end use.

Import permits may also cite such matters as:

• compliance with other state, territory and Commonwealth laws;
• the subsequent use of the therapeutic good;
• the custody, use, disposal or distribution of the imported goods;
• the keeping of records relating to the imported goods; and/or
• a time restriction within which the importation must occur.

Importers of therapeutic goods for commercial supply should familiarise themselves with the requirements of the Therapeutic Goods Act in relation to the importation of therapeutic goods for supply in Australia. Further information is available at http://www.tga.gov.au/.