Basic information
Outline of the system
Importation into Australia of therapeutic goods for human use is controlled under the Therapeutic Goods Act 1989, and its Regulations, and the Customs (Prohibited Imports) Regulations 1956 (PI Regulations).
Under the Therapeutic Goods Act 1989, 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 Goods Regulations 1990, 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 1989, 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 Australian 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 titled "Narcotic Drugs, Psychotropic Substances and Related Chemicals".
Product coverage
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; and - the substance is imported into Australia on the ship or aircraft; and - 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.
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
The controls under the Therapeutic Goods Act 1989 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.
Questions for products under restriction as to the quantity or value of imports
Not applicable
The system applies to products originating from which country?
The regulation applies to the importation of therapeutic goods from all countries.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
The controls on importation of therapeutic goods are statutory requirements under the Therapeutic Goods Act 1989, and associated regulations, and under the Customs Act 1901, and associated PI Regulations.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
What persons or firms are eligible to apply for a licence?
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.
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
Address
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Documentation requirements
What information is required in applications?
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);
• depending on the nature of the goods and the intended purposes, further documentation or evidence may be required.
What documents is the importer required to supply with the application?
Window of submission of an application
How far in advance of importation must application for a licence be made?
Application for importation should be made in advance of the arrival of the goods
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
Permits may be issued at any period of the year.
Issuing the license
Can a licence be granted immediately on request?
Permits may be issued immediately if a genuine emergency exists.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
In certain circumstances, import permission can be given for goods which have inadvertently arrived at the point of entry.
Which administrative body is responsible for approving application of licences?
Applications for import permits under regulations 5, 5G and 5H of the PI Regulations are processed and issued within the Department of Health.
Must the applications be passed on to other organs for visa, note or approval?
Are there any other conditions attached to the issue of a licence?
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.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
There is no licensing fee or administrative charge.
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
There is no deposit or advance payment requirement associated with the issue of licences.
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
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.
Are the reasons for any refusal given to applicants?
A request for review of the refusal can be made to the Australian Government Minister who administers the Therapeutic Goods Act 1989, within 90 days after the decision first comes into the importer's notice.
Have applicants a right of appeal in the event of refusal to issue a licence?
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.
If so, to what bodies and under what procedures?
In addition, an appeal may be made on the decision-making process itself under the Administrative Decisions (Judicial Review) Act 1977.
Importation
Are there any limitations as to the period of year during which importation may be made?
Permits may be issued at any period of the year.
What documents are required upon actual importation?
Import authorisation is usually issued in the form of a permit, but may be by letter of authority.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Importers of therapeutic goods for commercial supply should familiarise themselves with the requirements of the Therapeutic Goods Act 1989 in relation to the importation of therapeutic goods for supply in Australia. Further information is available at http://www.tga.gov.au/.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
Import permits may apply to one consignment only, or remain valid for successive consignments within a stated period (usually one year).
Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for the non-utilisation of a permit or a portion of a permit.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Permits are not transferable between importers.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Not applicable.
Is a licence required as a condition to obtaining foreign exchange?
Not applicable.
Is foreign exchange always available to cover licences issued?
Not applicable.
What formalities must be fulfilled for obtaining the foreign exchange?
Not applicable.