Controlled drugs and controlled equipment, materials or substances used for the manufacture of controlled drugs
- Document symbol
- G/LIC/N/3/SGP/20
- Original language
- English
- Published on
- 16/10/2024
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.
The Health Sciences Authority (HSA) of Singapore and the Central Narcotics Bureau (CNB) jointly regulate the import, export or transhipment of any controlled drugs and substances, including poppy seeds and its products.
Singapore abides by the International Narcotics Control Board's (INCB) allocation of quotas for narcotic drugs and psychotropic substances controlled under the United Nations (UN) Single Convention on Narcotic Drugs 1961 as amended by the 1972 Protocol and UN Convention on Psychotropic Substances 1971. Substances listed under the UN Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988 are controlled in accordance to the Convention.
A HSA licence is issued after evaluating that the applications of import and export for controlled drugs meet the national legislative requirements and complies to the UN Conventions. A CNB licence is required for the application of an import permit for controlled equipment, materials or substances used for the manufacturing of controlled drugs. Importation of poppy seeds or any food products containing poppy seeds requires the Inward Declaration Form to be approved by CNB.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
The controlled drugs (International controlled narcotic drugs and psychotropic substances) and precursor chemical subject to HSA's and CNB's import and export licensing procedures are listed in the table below.
Product | Laws/Regulations |
---|---|
Substances regulated as controlled drugs (CD), as specified in the First Schedule of the Misuse of Drugs Act | Misuse of Drugs Act and its Regulations |
Controlled equipment, materials or substances used for the manufacturing of controlled drugs, as specified in the Third Schedule of the Misuse of Drugs Act | Misuse of Drugs Act and its Regulations |
Poppy Seeds (kaskas) | Regulation of Imports and Exports Regulations |
Q3. The system applies to goods originating in and coming from which countries?
The licensing requirements apply to products 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?
The licensing requirements are for health and safety reasons, and to discharge Singapore's obligations under international agreements, such as the 1961 United Nations Single Convention on Narcotic Drugs, and the 1971 United Nations Convention on Psychotropic Substances and the 1988 Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.
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 laws, regulations and/or administrative orders under which the licensing procedures are maintained, are listed in our response to Question 2. The licensing requirements are statutorily required and published in government gazettes. While the administration of the licensing requirements is undertaken by the respective agency, the designation of products to be subjected to licensing and the abolishment of any licensing system require 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?
The INCB allocates annual quotas on its website, based on the local consumption needs. HSA also provides information on Singapore’s quotas to interested parties upon request. The quota does not discriminate between countries of origin. There is no limit to the amount an importer can import as long as Singapore’s quota for that controlled drug is not exceeded, and the purpose of the import is for legitimate uses (e.g. medical needs, scientific research or testing). Where there is a need to go beyond Singapore’s current annual quotas due to legitimate reasons, HSA can submit a request to INCB for an increase in the quota allotted.
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?
The import licence is valid for the import consignment of a specific controlled drug for 6 months from the date of issuance. The importer will need to apply for a new import licence for another consignment or if the licence has expired.
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.)
The quota applies to all narcotic drugs and psychotropic substances controlled under the UN Drug Conventions. Unused quantities from unfulfilled importations are credited back to the quota for the current year. There is no carryover of unused quantity from the previous year. Prior to importation of the narcotic drugs and psychotropic substances into Singapore, the competent authority of the exporting country will request for Singapore’s import licence to ascertain that Singapore has authorised the import before a corresponding export licence is issued. The import licence contains details of the substance to be imported, particulars of the importer and exporter, purpose of import, licence validity period and licensing conditions.
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?
There are no limitations on the period of the year during which applications for licence may be made.
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Import licences for controlled drugs will be issued within 20 working days upon receipt of the completed application form and full set of supporting documents.
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
There are no limitations on the period of the year during which importation may be made. Import licences are granted for immediate importation and are valid for six months from the date of issuance.
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?
Consideration of importer’s licence for controlled drugs is effected by a single administrative body (i.e. HSA). The importer does not have to approach more than one administrative body.
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?
The licenses are processed and issued on a first come, first serve basis. There is no maximum amount allocated per applicant as long as Singapore’s quota for that controlled drug is not exceeded and the purpose of import is for legitimate use.
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?
Singapore's national legislation, the Misuse of Drugs Act and Misuse of Drugs Regulations, mandates the application for licences to import and export controlled drugs. Licences are only issued after regulatory evaluation to determine that the importer meets the requirements. The UN Single Convention on Narcotic Drugs and UN Convention on Psychotropic Substances require the authorisation from both the importing and exporting countries for the controlled narcotic drug or psychotropic substance.
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?
All imports should be for legitimate uses, whether it is for local consumption or for export. If the importer has declared for a consignment of narcotic drugs and psychotropic substances to be imported for export only, this purpose of the request will be indicated on the import licence, and the quantity approved for import will not be counted towards Singapore’s annual quota.
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)?
For poppy seeds, controlled equipment, materials or substances used for the manufacturing of controlled drugs, permit applications should be made in advance of arrival of the goods. The application processing time generally takes give working days if all required supporting documents are provided.
For controlled drugs, application for import licence must be submitted to HSA at least 20 working days in advance of importation, providing all required supporting documents. Controlled drugs are not allowed to be imported without an import licence.
Q7.b. Can a licence be granted immediately on request?
Processing time will be required as per the application type. Please refer to Answer 29.
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.
There are no limitations on the period of the year during which applications for licence and/or importation may be made.
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?
For controlled equipment, materials or substances, the consideration of application is effected by solely CNB. For poppy seeds and its products, the importer must first obtain a sample analysis report from HSA. If there are no traces of morphine detected, CNB will endorse and approve the Inward Declaration Form.
For controlled drugs, applications of import licences are processed by HSA.
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 for an import licence is usually granted if it meets the stipulated criteria. In the event of a refusal for issuance, the reason(s) is/are generally provided. An applicant who is refused a licence may appeal against the decision in writing for reconsideration.
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?
Prior to applying for licences to import controlled drugs or psychotropic substances, the importer has to hold the relevant licences issued by HSA as outlined in paragraph 9 of section 9 below on Therapeutic Products, Medical Devices, Chinese Proprietary Medicines, Oral Dental Gums, Cell, Tissue and Gene Therapy Products; and Active Ingredients.
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?
The following information is required in applications for import permits: particulars of importer, company registration certificate issued by the Singapore Registry of Companies and Businesses, product description, product quantity, mode of transport, port of shipment/transport, product brand/serial number/model/make, country of origin, applicant details, warehouse details and responsible person. The following additional information is required for the specified permits:
- For application of import permit for controlled equipment, materials or substances, a valid CNB Licence number, descriptions of goods and packaging, purpose and usage of goods, date of permit application, name of supplier and consignee.
- For application of HSA's licence, the requirements can be found on its website.
- For application of CNB's licence, the necessary supporting documents include sale agreement, invoice and purchase order.
Q11. What documents are required upon actual importation?
Upon actual importation, importers are required to make an Inward Declaration showing the correct description and quantities of each consignment made electronically through TradeNet. Shipping documents such as the Bill of Lading/ Airway Bill and invoice are also required.
For poppy seeds and its products, the submission of the Inward Declaration Form should be accompanied by a HSA sample analysis report, and an export authorisation issued by the exporting country, if any.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
The fees related to HSA's import licence are published on HSA's website. CNB does not charge any 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 are no deposit or advance payment requirements associated with the issuance of licences.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
For the import of controlled drugs, the licence, approval or authorisation is issued on a per consignment basis and is valid for six months from the date of issuance. There is no renewal for an impot licence.
CNB’s importer licence is valid for three months and the validity may be extended by renewal.
Q15. 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 licence or a portion of it.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences are not transferable without the approval in writing from the relevant authority.
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 import licence contains details of the substance to be imported, particulars of the importer and exporter, purpose of import, licence validity period and licensing conditions. The quantity should not exceed the quantity stated on the licence and has to be imported in one consignment.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
There are no other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation.