Pharmaceuticals, medical materials and traditional medicines
- 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 pharmaceuticals, medical materials and traditional medicines. 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.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
For licenses administered by the Ministry of Health: pharmaceuticals, medical materials and traditional medicines (products are in HS 3001, 3002, 3003, 3004, 3005, and 3006).
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?
The import licensing of pharmaceuticals, medical materials, legitimate medicines and traditional medicines does not restrict the quantity or value of imports. 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.
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 Prohibited and Restricted Goods, Prakas No. 093 dated 9 February 2015 amending Prakas No. 1031 on Drug Import-Export Procedures, and Prakas No. 854 dated 18 February 2021 on Procedures and Conditions for Import, Export and Control of Chemicals.
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?
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?
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.)
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?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
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?
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?
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?
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)?
No advance application is required; licenses can be applied for at any time. 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.
Q7.b. Can a licence be granted immediately on request?
Based on Prakas No. 093 dated 9 February 2015 and Joint Prakas No.1356 dated 18 November 2016, the timeline is ten working days.
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.
No, there are no limitations as to the period of the year during which application for license 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?
The license application is considered, and the license granted by a single organ, the Department of Drugs and Food, Ministry of Health.
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 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. In such a case, the Ministry of Health will suggest to the importer to register the drug and submit full documentation supporting the registration. Applicants who are refused a license may appeal to the Minister of Health. 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.
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 date 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 Khmer application form, Bill, list of products, Invoice, Packing list and attach these with the license.
Q11. What documents are required upon actual importation?
The import license and the usual import documentation (see requirement above).
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
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 deposits or advance payments are 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 for two years, and the company must submit a renewal two months before the expired date.
(b) Import Permit: Validity is one month and cannot be extended.
Q15. 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.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
No, licences are not transferable between importers.
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?
No other conditions.
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 permits: (by Hard Copy)
Submit import documents to single window for process payment. Pass to Pharmaceutical Trade Bureau. Pass to Deputy Director. Pass to DDF Director. Pass to Deputy General Director of Health. Pass to General Director of Health. Pass to Cabinet MOH. Pass to Secretary of State/Minister of Health. Procedure for import permits (through National Single Window by online):
Submit import documents to National Single Window Verifier (Trade bureau): - Level 1: Officer
- Level 2: Chief Officer
- Level 3: Deputy Director
Reviewer: - Level 1: DDF director
- Level 2: General Director of health
Approver: - Level 1: Secretary of state
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, the company processes with the ACLEDA Bank. Foreign exchange is freely available to all importers.