Basic information
Outline of the system
Licences and permits are issued to control the import of specified narcotic drugs, psychotropic substances and related chemicals, including kava.
Product coverage
This system fulfils part of Australia's obligation under three United Nations Conventions in relation to restricting the supply of controlled substances to that necessary to meet medical and scientific need and preventing diversion to the illicit drug market. The drugs covered are substances listed in Schedule 4 of the Customs (Prohibited Imports) Regulations 1956 (PI Regulations). The licensing system covers persons involved in international trade of those substances listed in Schedule 4 of the PI Regulations, their derivatives, precursors and related substances. These include the drugs and chemicals required to be controlled under the Single Convention on Narcotic Drugs, 1961, the Convention on Psychotropic Substances, 1971, and Table I and Table II of the Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988.
An exemption applies in the case of a drug that is imported by a passenger on a ship or aircraft where the drug:
(a) (i) is required for the medical treatment of the person or another passenger under the care of the person; (ii) was prescribed by a medical practitioner for the purpose of that treatment; and
(iii) was supplied to the person in accordance with the prescription of the medical practitioner.
(b) (i) is required for the medical treatment of an animal that is being imported and is under the care of the person; (ii) was prescribed by a veterinarian for use in the animal for the purposes of that treatment; and (iii) was supplied to the person in accordance with the prescription of the veterinarian.
An exemption applies in the case of kava that is imported by a commercial entity for the purposes of sale as a food.
Incoming passengers who are over the age of 18 years are allowed to bring 4kg of kava (piper methysticum) either in the root or dried form, other than a product listed or registered under the Therapeutics Goods Act 1989, into Australia in their accompanied baggage.
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 use of import licences and permits enables the Government to restrict and monitor the quantities of controlled substances imported. This is intended to prevent the over-supply and diversion of controlled substances and is one strategy adopted to address drug misuse. The system is based on the requirements of the international treaties. 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 system applies to importers of controlled substances from all countries.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
The Customs Act 1901 (Customs Act) and the PI Regulations govern the importation of drugs. The licensing of importers is a statutory requirement under paragraphs 50(3) (a) and (b) of the Customs Act. The drugs subject to control are specified in Schedule 4 under Regulation 5 of the 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?
Any person, firm or institution may apply for a licence. A licence shall not be granted unless the applicant is a fit and proper person to be granted a licence to import drugs and suitable security arrangements for the holding of drugs are in place. A licence is granted subject to conditions concerning use, sale and distribution of the substances. Import permits are only issued to licence holders. State licence or legislative exception must be supplied at the time of applying for a licence to import. Any person, firm or institution may apply for a license to import kava. If the kava is imported as a food only a commercial entity may apply.
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?
The following information must be supplied for a licence application:
- name of the applicant (person or organisation);
- address of the premises on which the controlled substance will be held;
- nature of the business (e.g. pharmaceutical manufacture, chemical distribution, etc.);
- classes of controlled substances to be held (e.g. narcotic drugs, psychotropic substances, precursor chemicals, laboratory standards, etc.);
- details of licences held relating to the storage, manufacture or distribution of the substances;
- details of any losses and/or thefts of controlled substances;
- details of all persons who will have access to the controlled substances, including their positions and qualifications and specific background information to enable a security check;
- details of the security arrangements for the storage, distribution and handling of the substances;
- details relating to the applicant's appointment of an agent (e.g. shipping agent, customs agent);
- proposed importing activity for the period of the licence including drug names and proposed quantities.
The following information must be supplied for a permit application:
- importer's name and address;
- overseas exporter's name and address;
- product description (name, form and strength);
- number and size of the packs;
- quantity of drug;
- proposed date of import;
- where applicable, the name of the end user and the use of the end substance.
A separate Permit to Import is required for every shipment of a controlled substance and will not be issued unless a licence is already held. All permits must be obtained in advance of the controlled substance arriving in Australia.
What documents is the importer required to supply with the application?
Applications for licences and permits must be submitted on either an "Application for a Licence to Import Controlled Substances" or "Application for a Permit to Import Controlled Substances" respectively.
Window of submission of an application
How far in advance of importation must application for a licence be made?
There is no minimum advance notice required for a licence. However, stringent checks of applicants for licences are undertaken in order to issue a licence. Applications for an import permit should be made a minimum of 20 days prior to import. Permits will only be issued to a licensed importer.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
No.
Issuing the license
Can a licence be granted immediately on request?
No.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Goods arriving at the port without a permit cannot be imported and retrospective permits cannot be issued.
Which administrative body is responsible for approving application of licences?
Import licences and import permits are both issued by the Department of Health and Aged Care. When considering licence applications, State licence or legislative exception must be supplied at the time of applying for a licence to import, the company applying contacts the relevant State Authority.
Must the applications be passed on to other organs for visa, note or approval?
Other authorities may be contacted by the Department of Health and Aged Care to verify application details (for example, the Australian Border Force for personnel checks of the company applying). The applicant does not need to approach these authorities.
Are there any other conditions attached to the issue of a licence?
For licences, conditions apply to the keeping of records and the reporting of movements. For permits, specific conditions may be endorsed on the permit, (for example for re-export only or for veterinary use only) .
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?
An application may be refused for any of the following reasons:
• The criteria are not met. These criteria require the importer to be a "fit and proper person" and maintain adequate security for storage.
• If other permission is required but has not been obtained (for example, quarantine, State licences) .
A licence or permit may be revoked if the licence holder fails to comply with the conditions of the licence or permit.
Are the reasons for any refusal given to applicants?
The affected person is notified in writing of any refusal or revocation. A request for review of the refusal can be made to the Australian Government Minister administering 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?
Importation
Are there any limitations as to the period of year during which importation may be made?
No.
What documents are required upon actual importation?
The import permit is the required document and, for some substances, the corresponding overseas export permit.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Importers of narcotic drugs, psychotropic substances and related chemicals 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.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
Import licence validity can vary from six months to two years depending on the substances being imported. Import permits are usually valid for up to six months.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
No. However, if a licence holder has not used the licence during the year and applies for a renewal, the applicant may need to justify retention of the licence.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences and permits are not transferable.
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.