Narcotic drugs, psychotropic substances and related chemicals
- Document symbol
- G/LIC/N/3/AUS/16
- Original language
- English
- Published on
- 27/11/2023
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.
Licences and permits are issued to control the import of specified narcotic drugs, psychotropic substances and related chemicals, including the importation of kava as a food.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
This system fulfils part of Australia's obligation under three United Nations Conventions in relation to restricting the supply of controlled substances that are 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, in addition to items listed under Schedule 7A and Schedule 8 of the PI Regulations. 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.
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.
Q3. The system applies to goods originating in and coming from which countries?
The system applies to importers of controlled substances from all countries.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
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 and diversion. The system is based on the requirements of the international treaties. The PI Regulations are not specifically intended to restrict the quantity or volume of imports.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
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. This system cannot be abolished without legislative approval.
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
There is no minimum advance notice required for a licence. However, stringent checks of applicants for licences are undertaken to issue a licence. Applications for an import permit should be made a minimum of 20 working days prior to import. Permits will only be issued to a licensed importer where a licence is required. Goods arriving at the port without a permit cannot be imported and retrospective permits cannot be issued.
Q7.b. Can a licence be granted immediately on request?
No.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
No.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Import licences and import permits are both issued by the Department of Health and Aged Care (DoHAC). 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. Other authorities may be contacted by the DoHAC 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.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
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.
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. 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.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
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 licence to import kava. If the kava is imported as a food, only a commercial entity may apply for an import permit, and a licence is not required.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. 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.
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); and
- 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; and
- where applicable, the name of the end user and the use of the end substance.
A separate Permit to Import (import permit) is required for every shipment of a controlled substance and will not be issued unless a licence is already held, where applicable. All permits must be obtained in advance of the controlled substance arriving in Australia.
Q11. What documents are required upon actual importation?
The import permit is the required document and, for some substances, the corresponding overseas export permit.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
There is no licensing fee or administrative charge.
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
There is no deposit or advance payment requirement associated with the issue of licences.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
Import licence validity can vary from six months to three years depending on the substances being imported. Import permits are usually valid for up to six months.
Q15. 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.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences and permits are not transferable.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
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) .
Other Procedural Requirements
Q18. 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.