Narcotics, psychotropic substances and precursors
- Document symbol
- G/LIC/N/3/KHM/5
- Original language
- English
- Published on
- 08/05/2024
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 Ministry of Health (MoH) administers the import licensing (or permit) regime for narcotic drugs and related substances. Its purpose is to protect human health. The import licensing of narcotics, psychotropic substances and precursors is designed to allow Cambodia to meet accepted international standards for trade in such goods.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
Licenses are administered by the Ministry of Health for narcotics, psychotropic substances and their precursors, when the importer declares that the precursors are to be used for medical purposes (products are in HS 1211, 2921, 2922, 2924, 2925, 2926, 2927, 2932, 2933, 2934, and 2939).
Q3. The system applies to goods originating in and coming from which countries?
The systems apply to products originating from all countries. There is no discrimination by country of origin.
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?
Narcotics, psychotropic substances and their precursors, when the importer declares that the precursors are to be used for medical purposes: the quantity of imports may be restricted. The system is designed and administered so as to allow Cambodia to comply with various international conventions on narcotics and psychotropic substances and with its responsibilities as a member of the International Narcotics Control Board.
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?
Import licensing is maintained and statutorily required under the Law on Amending the Law on Drug Management, dated 28 December 2007 and Law on Drug Control dated 27 January 2012, Ankuret (Sub-Decree) No. 17 ANK/BK dated 26 February 2020 on the Enforcement of the List of Prohibited and Restricted Goods, Prakas No. 093 dated 9 February 2015 amending Prakas No. 1031 on Drug Import-Export Procedures, and Prakas No.1467 dated 28 March 2022 on Management import, export and distribution of raw materials, narcotics, psychotropic substances and precursors.
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 relatively small number of authorized importers is fully informed of the necessary procedures. Information on quotas and imports is not made public.
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 size of the quota is determined by Cambodia's annual submission to the International Narcotics Control Board (INCB).
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.)
License is issued to those registered firms approved by a Ministry of Health Committee chaired by the Minister.
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?
MOH issues released import license is base retail sale and public hospital needed.
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Timeline is 20 working days if the application and supporting documents are complete.
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Importation may take place immediately after the issuance of a license.
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?
All license procedures are executed by the Ministry of Health.
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?
Allocations among approved firms are determined by past allocations, adjusted in the light of previous annual patient demand report.
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?
No.
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?
A license application may be refused if it fails to meet the ordinary criteria, or if granting the license is inconsistent with Cambodia's commitments to the International Narcotics Control Board (INCB).
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?
No, only companies registered by the Ministry of Health may import pharmaceuticals and narcotics. All Cambodian firms are eligible to be so registered, provided that they have at least one employee who is a licensed pharmacist. In accordance with Prakas of the Ministry of Health No. 254 dated 13 June 1996 and Joint Prakas No. 1356 dated 18 November 2016, there is a registration fee of 1,000,000 riels (for each product registered) to be paid by the company to the Ministry of Health. A list of authorized importers is available at the Department of Drugs and Food, Ministry of Health. At present, 591 companies, dated 20 October 2022, are authorized to import pharmaceuticals and narcotics.
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?
Applicants must submit import documents such as the Khmer application form, list of products, Proforma Invoice, Retail sale report.
Q11. What documents are required upon actual importation?
The import license and the usual import documentation (see requirement in above No.10).
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
The import licensing fee is 200,000 KHR (Joint Prakas No.1356 dated 18 November 2016).
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.
No deposit or advance payment is required.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
(a) Company License: Validity is two years and company must submit for a renewal two months before the expired date.
(b) Import Permit: Validity is eight months and cannot extended.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for non-utilization or under-utilization.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
The importer must present a report on the utilization and/or distribution of drugs previously imported.
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 importer must present a report on the utilization and/or distribution of drugs previously imported.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Procedure for Import permit: a. Submit import documents to single window for process payment. b. Pass to Pharmaceutical Trade Bureau. c. Pass to Deputy Director. d. Pass to DDF Director. e. Pass to Deputy General Director of Health. f. Pass to General Director of Health. g. Pass to Cabinet MOH. h. Pass to Secretary of State/Minister of Health.
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?
For payment, Company processing with ACLEDA Bank. Foreign exchange is freely available to all importers.