Basic information
Outline of the system
The Ministry of Health (MoH) administers the import licensing (or permit) regime for pharmaceuticals, medical materials and traditional medicines. Its purpose is to protect human health.
The import licensing of pharmaceuticals, medical materials and traditional medicines does not restrict the quantity or value of imports. Separate systems manage imports for retail sale and imports for hospital/clinic use.
Importation for retail sale is governed by the import licensing system described in this questionnaire. Importing for retail sale requires packaging suitable for purchase and/or consumption by individuals. Importation of registered pharmaceuticals packaged in bulk and designed for public hospital use is undertaken by tender and require an import license. The Ministry of Health and medical NGOs import under this regime, and the imports are duty-free. NGOs need a special authorization from the Ministry of Health to request a tender. The resulting imports must not be put into commercial retail channels.
Product coverage
For license administered by the Ministry of Health: pharmaceuticals, medical materials and traditional medicines (products are in HS 3001, 3002, 3003, 3004, 3005, and 3006).
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
Pharmaceuticals, medical materials and traditional medicines: the system does not restrict the importation of legitimate medicines. Its purpose is to protect human health, in particular by controlling and reducing illegal imports of pharmaceuticals, and to ensure the quality of the products based on registration products. No alternative methods have been developed due to insufficient technological and human capacities.
Questions for products under restriction as to the quantity or value of imports
Not applicable. Import permit for pharmaceutical products has no quotas.
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
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.
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
Address
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Documentation requirements
Application form - Medicines.pdfWhat documents is the importer required to supply with the application?
Applicants must submit import documents such as Khmer application form, Bill, list of products, Invoice, Packing list and attach with Products license.
Window of submission of an application
How far in advance of importation must application for a licence be made?
No advance application is required, licenses can be applied for at any time.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
No, there are no limitations as to the period of the year during which application for licence and/or importation may be made.
Issuing the license
Can a licence be granted immediately on request?
Based on Prakas No. 093 dated 9 February 2015, the timeline is ten working days.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Licenses are often issued for landed goods. Licenses can be obtained in ten working days, if the application and supporting documents are complete. Importation may take place immediately after the issuance of a license.
Which administrative body is responsible for approving application of licences?
The license application is considered and the license granted by a single organ, the Department of Drugs and Food, Ministry of Health.
Must the applications be passed on to other organs for visa, note or approval?
Are there any other conditions attached to the issue of a licence?
No other conditions.
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 may be refused only if it fails to meet the ordinary criteria, i.e., if the drug is not registered with the Ministry of Health.
Are the reasons for any refusal given to applicants?
In such a case, the Ministry of Health will suggest to the importer to register the drug and submit full documentation supporting the registration.
Have applicants a right of appeal in the event of refusal to issue a licence?
Applicants who are refused a license may appeal to the Minister of Health.
If so, to what bodies and under what procedures?
They may also appeal to a court of first instance (usually the Municipal Court of Phnom Penh). The decision of this court may be appealed to the Appellate Court.
Importation
Are there any limitations as to the period of year during which importation may be made?
No, there are no limitations as to the period of the year during which application for licence and/or importation may be made.
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 submit for renewal before expired date two months.
(b) Validity is two months and cannot be extended.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
No. Licenses are usually issued for landed goods and require presentation of invoices and packing lists. In principle, non-utilization or under-utilization cannot occur.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
No, licences are not transferable between importers.
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.