Basic information
Outline of the 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.
Product coverage
For license administered by the Ministry of Health: 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).
(Refer to ANUKRET (Sub-Decree) No. 17 ANKr.BK on the Enforcement of the List of Prohibited and Restricted Goods Issued dated 26 February 2020).
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Non-automatic licensing to Protect public morals;
Protect human, animal or plant life and health; protect environment; Pursue obligations under the UN Charter and other international treaties
Products under restriction as to the quantity or value of imports
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.
Questions for products under restriction as to the quantity or value of imports
Please see Answers 6.1-6.11
The system applies to products originating from which country?
The systems apply to products originating from all countries. There is no discrimination by country of origin.
Expected duration of licensing procedure
Ongoing
Legal requirements
Is the licensing statutorily required?
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 prohibited and restricted Goods and Prakas No. 093 dated 9 February 2015 amending Prakas No. 1031 on Drug Import-Export Procedures.
Law on Control of Drugs - Amendment of Law on Control of Drugs 9 May 2005 and New Law on control of Drugs 2 January 2012
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Is it possible for the government to abolish the system without legislative approval?
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
No. Only companies registered by the Ministry of Health may import pharmaceuticals and narcotics.
What persons or firms are eligible to apply for a licence?
All Cambodian firms are eligible to be so registered, provided that they have at least one employee who is a licensed pharmacist.
Is there a registration fee?
In accordance with the Prakas of the Ministry of Health No. 254 dated 13 June 1996, there is a registration fee is Joint Prakas No. 1356 date 18 November 2016, fee is 1,000,000 riels (for each product registered) to be paid by the company to the Ministry of Health.
Is there a published list of authorized importers?
A list of authorized importers is available at the Department of Drugs and Food, Ministry of Health. At present, 459 companies are authorized to import pharmaceuticals and narcotics.
Contact point for information on eligibility
Ministry/Authority
Ministry of Health
Address
80, Samdach Penn Nouth Blvd (289), Sankat Beoungkak 2, Tuol Kork District, Phnom Penh
Telephone
(855-23) 885-970/884 909
Fax
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Ministry of Health
Documentation requirements
What information is required in applications?
What documents is the importer required to supply with the application?
Applicant must submit import documents such as Khmer application form, list of products, Proforma Invoice, Retail sale report.
Window of submission of an application
How far in advance of importation must application for a licence be made?
Not applicable.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
Not applicable.
Issuing the license
Can a licence be granted immediately on request?
Not applicable.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Not applicable.
Which administrative body is responsible for approving application of licences?
Not applicable.
Must the applications be passed on to other organs for visa, note or approval?
Not applicable.
Are there any other conditions attached to the issue of a licence?
The importer must present a report on the utilization and/or distribution of drugs previously imported.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
Import licensing fee
What is the amount of the fee or charge?
Import licensing fee is 200,000 KHR (Joint Prakas No.1356 dated 18 November 2016).
Is there any deposit or advance payment required associated with the issue of licences?
No deposits or advance payments are required.
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?
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).
Are the reasons for any refusal given to applicants?
Have applicants a right of appeal in the event of refusal to issue a licence?
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?
Not applicable.
What documents are required upon actual importation?
The import license and the usual import documentation (see requirement in above No. 25).
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.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
(a) Company License: Validity is two years and company must be submitting for renewal before expired date two months.
(b) Validity is eight months and cannot extended.
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.
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.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
For payment, Company processing with ACLEDA Bank. Foreign exchange is freely available to all importers.
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?
The following questions are only 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)
Where is information on allocation and formalities for licences published? 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.
Is the size of the quota determined: on 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 a 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).
Are licences allocated 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 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.
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.
What are the minimum and maximum lengths of time for processing applications?
Timeline is ten working days if the application and supporting documents are complete.
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.
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.
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 remand report.
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?
Not applicable.
In cases where imports are allocated 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?
Not applicable.
Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
No.