Controlled drugs
- Document symbol
- G/LIC/N/3/NZL/10
- Original language
- English
- Published on
- 08/11/2023
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.
New Zealand is a party to the Single Convention on Narcotic Drugs 1961 (the Convention) and the Convention on Psychotropic Substances 1971. The purpose of the conventions is to have single international treaties concerned with the control of narcotic drugs and the production of raw materials of narcotic drugs and similar international control of psychotropic substances. Both narcotics and psychotropic drugs are classified as Controlled Drugs in New Zealand under the Misuse of Drugs Act 1975 ("the Act"). Psychotropic substances include barbiturates and benzodiazepines and some non-medicinal substances such as LSD.
The International Narcotics Control Board (INCB) monitors the compliance with the provisions of the conventions. The conventions set requirements for member countries with respect to regulatory provisions, reporting requirements and quotas.
Importing and exporting of controlled drugs (narcotics and psychotropics) requires an import or export licence to be issued prior to the shipment of drugs entering or leaving New Zealand. Applications are submitted to Medicines Control Medsafe section of the Ministry of Health. Licences are issued for medicinal (human consumption/veterinary use), scientific (including analysis for law enforcement) or drug-detector training purposes only.
A Licence to Deal in Controlled Drugs or a Licence to Possess Controlled Drugs or a Medicinal Cannabis Licence, or authorisation under the Act (e.g. a registered medical practitioner), is required before the issuance of licences to import or export controlled drugs.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
Import and export licensing is required for controlled drugs listed in Schedules 1, 2, 3 (excluding part 6) of the Misuse of Drugs Act 1975. A Licence to Deal in Controlled Drugs or a Licence to Possess Controlled Drugs or a Medicinal Cannabis Licence, or authorisation under the Act (e.g. registered medical practitioner), is required before the issuance of licences to import or export controlled drugs.
Q3. The system applies to goods originating in and coming from which countries?
The system applies to goods originating in and coming 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?
Licensing is intended to restrict the quantity of imports to quotas issued by the INCB. The INCB administers a system of estimates for narcotic drugs and a voluntary assessment system for psychotropic substances. As a signatory to the conventions no alternative methods are permissible.
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 domestic law under which licensing is maintained is the Misuse of Drugs Act 1975, the Misuse of Drugs Regulations 1977, and the Misuse of Drugs (Medicinal Cannabis) Regulations 2019. The schedules of the Act define the class of each controlled drug. All controlled drugs require import and export licences and licences to deal or possess, or a Medicinal Cannabis licence, or alternatively an authorisation within the Act. Part 2 of the Regulations covers the requirements and issuance of licences under the Act.
Licensing is statutorily required and there is no administrative discretion as to the products to be subjected to licensing. The legislation defines the restrictions applicable to drugs listed in each schedule to the Act. It is not possible for the government (or the executive branch) to abolish the system without approval of the legislature.
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?
Quotas (also known as 'estimates' and 'assessments') for the import of controlled drugs can be viewed at the INCB website: www.incb.org. The Competent National Authorities (the authority responsible for administration of the regulatory regime in that country) are advised to check their quota status regularly online. Quotas are set for the country not for specific importers.
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?
Quotas are established on a yearly basis, running from 1 January - 31 December each year. The size (quantity in kilograms or grams) of a quota is determined by the stock on hand as of 31 December each year as well as previous, current and projected consumption. Supplementary quotas can be applied for from the INCB, if required, during the year. Licences are issued per consignment. Importers are required to apply for a licence every time they wish to import or export. Import and export licences are only valid for 6 months from the date of issue.
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.)
Import licences are endorsed by New Zealand Customs Services at the time of Customs clearance at the New Zealand border. Another copy of the import licence is endorsed by the importing company/entity. These copies of the licence are returned to Medicines Control and the information provided regarding the actual quantities imported is updated in databases. This information is relied on for reporting to the INCB of statistics of imports and exports on a quarterly basis, as well as in the determination of consumption (within New Zealand) in collaboration with information on stocks held. Unused allocations cannot be rolled over into the next year. Licences cannot be used multiple times.
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?
Applications are demand driven. Applications can be made at any time.
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Medicines Control advises applicants to allow up to 30 working days for the processing of import applications. There may be delays in the processing of applications where the information provided is inaccurate or incomplete, or if additional quota is required.
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
An importation may be made as soon as the import licence is issued and the competent national authority in the country of export has issued the appropriate export authorisation/licence.
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?
Prospective importers can obtain application forms by requesting these from Medicines Control. The application form can be submitted securely through the Medicines Control Online System platform and the licences are administered by Medicines Control, Medsafe, Ministry of Health. Where applicable, the Agricultural Compounds and Veterinary Medicines (ACVM) regulator is consulted on importations for veterinary controlled drugs which are subject to a registration under the ACVM Act. The Ministry for Primary Industries (MPI) may also be involved with the import of varieties of plants prohibited under the Act, which contain controlled drugs. Ministerial approval is necessary for the import and export of controlled drugs listed in schedule 1 (with the exception of cocaine), Part 1 and Part 2 of schedule 2 of the Act (excluding morphine and opium) and Part 1 of schedule 3. Following the issuance of an import licence, the competent national authority of the country of export must be approached for an export licence/authorisation.
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?
Applications are examined and processed on receipt. If the application exceeds the current quota, there will be a delay while extra quota is requested from the INCB. Generally extra quota is allowed as long as it can be justified by a licit purpose.
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?
Competent national authorities in other countries that are signatories to the INCB Conventions require an import licence issued by New Zealand before exporting from their country.
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?
The importing country is informed of the effect given by the exporting country by the transfer of the appropriate copies of standardised import and export licences required by the INCB for signatories to the conventions.
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Licences may be issued with an additional condition to reflect that the import is for re-export (or partial re-export). The INCB has advised that import licences issued with this condition should not be used in determination of compliance with quotas.
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)?
Q7.b. Can a licence be granted immediately on request?
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.
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?
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?
The most common reason for refusal is that the importer is not authorised to deal in controlled drugs in New Zealand. The reason for refusal is advised and an application form for an appropriate licence outlining the requirements for a licence may be provided if appropriate. Licences must be issued prior to the arrival or exit of goods. Licences to import cannot be issued retrospectively.
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?
The importation of controlled drugs operates under a restrictive system as required by the international conventions. Only importers with a Licence to Deal in Controlled Drugs, or a Licence to Possess Controlled Drugs, or a Medicinal Cannabis Licence, or an authorisation under the Act (e.g., a registered medical practitioner) are eligible to apply for import licences.
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?
A sample of an application for an import licence is provided. Applicants are occasionally requested to provide additional documentation depending on the nature and purpose of the importation (e.g., confirmation of ethics approval where the controlled drugs are being imported for a clinical trial).
Q11. What documents are required upon actual importation?
The export licence copy must accompany the goods across the border and match up with the import licence copy. Licences to import (and export) are issued in quintuplicate. Each copy has a specific purpose as stated on the bottom of the copy and must be retained or forwarded to the appropriate authority.
Original copy: licensee to forward to the exporter for presentation to the Authorities in the country of export.
Duplicate copy: New Zealand Customs to complete "Import Certification".
Triplicate copy: Importer to complete "Importer's Certification".
Quadruplicate: Importer's copy.
Quintuplicate: Copy retained by the Ministry of Health.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
The fee for an import or export application is NZ$194.22 (inclusive of Goods and Services Tax). Up to four controlled drug preparations may be listed on one import or export application, however these must all be within the same consignment.
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.
Payment in full is required prior to issuing of a licence. The fee is not refundable if an import or export licence expires.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
An import or export licence is valid for 6 months from the date of issue. No extensions can be given.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
No.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
No.
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?
The standard conditions on an import licence are:
- That the goods must be imported before the expiry date of ...... [six months from date of issue]
- That the controlled drugs are only used for medical, scientific or dog-training purposes only
Other conditions that the Licensing Authority may deem necessary can be added to a licence
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Yes, the importer must have a Licence to Deal in Controlled Drugs or a Licence to Possess Controlled Drugs or a Medicinal Cannabis licence, or be authorised to possess controlled drugs under the Act.
Q19. Is foreign exchange automatically provided by the banking authorities for goods to be imported? Is a licence required as a condition to obtaining foreign exchange? Is foreign exchange always available to cover licences issued? What formalities must be fulfilled for obtaining the foreign exchange?
Not applicable. A licence to import is issued to a New Zealand entity.