RESTRICTEDWORLD TRADE
ORGANIZATIONWT/ACC/KHM/17/Rev.1
3 March 2003
(03-1223)
Working Party on the
Accession of CambodiaOriginal:  English
ACCESSION OF CAMBODIA
Revised information on Import Licensing Procedures
Revision
The Government of the Kingdom of Cambodia has submitted the following revised
information on import licensing procedures, with the request that it be circulated to members of the
Working Party.
_______________WT/ACC/KHM/17/Rev.1
Page 2
QUESTIONNAIRE ON IMPORT LICENSING PROCEDURES
Outline of systems
The import licensing (or permit) system app lies to administer imports of pharmaceuticals,
medical materials and agricultural inputs such as chemical pesticides and chemical fertilizers. This
system was introduced for the purpose of admini stering imports of goods, which may affect human
health and consumers, and environmental welfare. This  system is not designed to restrict the quantity or
value of imports.
In accordance with the Governmental Sub-Decr ee on Management and Control of the Imports,
Production, Distribution, and Purchasing and Sale of  all kind of Explosives and Ammunition, No. 38
dated 30 April 1999, Imports of explosives, ammunition, military hardware and other related products
for military purpose is under the administration of the Ministry of Defence, while imports of those same
products for the security purpose is under the ad ministration of the Ministry of Interior.
Imports of pharmaceuticals and medical materials is under the administration of the Ministry of
Health in accordance with the Law on Drug Management dated 9 May 1996 and  "Prakas No. 82 on
Drug Import-Export Procedures" dated 31 March 1999, while imports of chemical pesticides and
fertilizers is under the administration of the Ministry  of Agriculture, Forestry and Fisheries (MAFF) in
accordance with the Law on Drug Management da ted 9 May 1996 and the S ub-Decree on Standards
and Management of Agricultural Materials dated 28 October 1998.
Purposes and coverage of licensing
1. Products covered
Pharmaceuticals and medical materials
Import licensing is applied to imports of pharm aceutical products and materials, including raw
pharmaceutical materials, bulk and finished pr oduct. Import products under the licensing system
are listed with the following 6 digits of HS code of Tariff Structure of Cambodia:
300110, 300120, 300190, 300210, 300210, 300230, 300290, 300310, 300320, 300330, 300340,
300390, 300410, 300420, 300430, 300440, 300450, 300490, 300510, 300590, 300610, 300620,
300630, 300640, 300650, 300660.
Agricultural inputs
Import licensing is applied to imports of agricultural inputs, including raw materials, semi-
and finished products. Import products under the licensing system are listed with the
following 6 digits of HS code:
310100, 310210, 310220, 310230, 310240, 310240, 310250, 310260, 310270, 310280, 310290,
310310, 310320, 310390, 310410, 310420, 310430, 310490, 310510, 310520, 310530, 310540,
310550, 310560, 310590, 380810, 380820, 380830, 380840, 380890.
2. Country coverage
Pharmaceuticals and medical materials
The system applies to the products covered originating from all countries. There is no
discrimination by country of origin.WT/ACC/KHM/17/Rev.1
Page 3
Agricultural inputs
The system applies to the products covered originating from all countries. There is no
discrimination by country of origin.
3. 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?
Pharmaceuticals and medical materials
The purposes of the licensing system are not to restrict the quantity or value of imports but to
protect the health of consumers and people, envi ronmental and animal welfare. It is also to
control and reduce the illegal imports of pharmaceu ticals; and to ensure the quality of the
products based on WHO and FAO st andards. No alternative methods have been developed due
to insufficient technological and human capacities and the lack of relevant technical assistance.
Agricultural inputs
Import licensing is not intended to restrict the quantity and value of imports, except for
pesticides.  Import quantities of pesticides by individual companies may be restricted  subject
to safety requirements, including appropriate storage facilities. In addition, the overall level of
imports of pesticides will be limited to estimated domestic demand. This procedure is aimed
to guarantee consistent high quality of pesticides and to protect end-users and consumers.
In the future, two alternative methods may be used:- Allow goods into the warehouse and carry out inspection before release for sale or use;
- Accreditation through bilateral agreements with countries of origin.
4. Cite the law, regulation and/or admini strative 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 thegovernment (or the executive br anch) to abolish the system without legislative approval?
Pharmaceuticals and medical materials
Import licensing is maintained and st atutorily required under the Law on Drug
Management dated 9 May 1996 and "Prakas No. 82 on Drug Import-Export Procedures" dated
31 March 1999.
The abolishment and/or amendment of the exis ting import licensing system can be done only
through the legislative approval.
Agricultural inputs
Import licensing is maintained and statutorily required under the Law on Drug Management
dated 9 May 1996 and the Sub-Decree on Standards and Management of AgriculturalMaterials dated 28 October 1998.
The abolishment and/or amendment of the exis ting import licensing system can be done only
through the legislative approval.WT/ACC/KHM/17/Rev.1
Page 4
Procedures
5. For products under restriction as to the quantity or value of imports (whether applicable
globally or to a limited number of countri es or whether established bilaterally or
unilaterally):
The value of imports of pesticides is not restricted. However, the quantity of such exports is
under restriction. Within the annual limitations on quantities, licenses are granted on a first come-first
served basis, except that licenses will not be grante d to importers when their storage facilities are fully
utilized. In all other respects the procedures as outlin ed for all agricultural inputs in (6.), below, apply.
6. Where there is no quantitative limit on import ation of a product or on imports from a
particular country:
(a) How far in advance of importation must application for a licence be made?  Can
licences be obtained within a shorter time-lim it or for goods arriving at the port without
a licence (for example, owing to inadvertency)?
Pharmaceuticals and medical materials
There is no time limit for the application for an  import licence. Licence can be obtained within
7 days, if application and supporting documents submitted are complete.
Agricultural inputs
There is no time limit for the application for an  import licence. Licence can be obtained within
7 days, if application and supporting documents submitted are complete.
(b) Can a licence be granted immediately on request?
Pharmaceuticals and medical materials
No. In urgent cases, licence can be provided within a shorter period.
Agricultural inputs
No. Upon justified request, license can be provided within a shorter period.
(c) Are there any limitations as to the peri od of the year during which application
for licence and/or importation may be made?  If so, explain.
No limitations for both import licensing systems.WT/ACC/KHM/17/Rev.1
Page 5
(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?
Pharmaceuticals and medical materials
Yes.  The licence application is effected by onl y one organ, which is the Department of Drugs
and Food, Ministry of Health.
Agricultural inputs
The license application is effected by only one organ, which is the Department of Agricultural
Legislation, MAFF
7. Under what circumstances may an applicatio n for a licence be refused other than failure
to meet the ordinary criteria?  Are the reaso ns for any refusal given to the applicant?
Have applicants a right of appeal in the even t of refusal to issue a licence and, if so, to
what bodies and under what procedures?
Pharmaceuticals and medical materials
Licence applications are refused only when they failed to meet the ordinary criteria, e.g.
unregistered drugs. If the drugs or other medical materials are not yet registered, the Ministry
of Health will suggest to the applicant to register and submit full supporting documents. The
applicant has the right to appeal through the judicial and administrative procedures as
described in the Memorandum on the Foreign Trade Regime of Cambodia, Chapter III,Section 6 (document WT/ACC/KHM/2).
Agricultural inputs
Licence applications are refused only when they failed to meet the ordinary criteria. As
regards pesticides, an importer that would otherw ise be eligible for a license may be denied a
license if its storage facilities are fully utilized. The applicant has the right to appeal throughthe judicial and administrative procedures as described in the Memorandum on the Foreign
Trade Regime of Cambodia, Chapter III, Section 6 (document WT/ACC/KHM/2).
Eligibility of importers to apply for licence
8. Are all persons, firms and instit utions eligible to apply for li cences. If not, is there a system
of registration of persons or firms permitte d to engage in importation?  What persons or
firms are eligible?  Is there a registration fee?  Is there a published list of authorized
importers?
Pharmaceuticals and medical materials
Not all persons, firms and institutions are elig ible to apply for licences. The persons who are
eligible for the licence application should be bot h a pharmacist and his company. This company,
for its eligibility for import activity, should al so be a pharmaceutical company registered with
the Ministry of Commerce and author ized by the Ministry of Health.
Pharmaceuticals allowed for importation to Ca mbodia should meet the following conditions:WT/ACC/KHM/17/Rev.1
Page 6
- The importing company should be a Pharmaceu tical company registered at the Ministry
of Commerce and authorized by  the Ministry of Health.
In accordance with the Prakas of Ministry of Health, No. 254 dated 13 June 1996, there is a
registration fee of US$200 (for each product registered) to be paid by the company to theMinistry of Health
A list of authorized importers is available at  the Department of Dr ugs and Food, Ministry of
Health.  At present, there are 90 authorized companies.
Agricultural inputs
Not all persons, firms and institutions are eligible to apply for licenses. As regards veterinary
medicines, the persons who are eligible for the license application should be both an
agricultural technician and his company. A company importing agricultural inputs should be
registered with Ministry of Commerce and author ized by the Ministry of Agriculture, Forestry
and Fisheries.
There is registration fee of US$30 (for each pr oduct registered) to be paid by the company to
the Ministry of Agriculture, Forestry and Fisheries.
A list of authorized importers is available at the Department of Agricultural Legislation
Ministry of Agriculture, Forestry and Fisheries upon request. At present, there are 15
authorized companies.
Documentation and other requirements for application for licence
9. What information is required in applications?  Submit a sample form.  What documents is
the importer required to supply with the application?
Pharmaceuticals and medical materials
Importers should present usual import documentation for licence application as described in
the documents and sample attached as Annex I.
Agricultural inputs
Importers should present the usual import documentation for license application. Sample
forms are attached to this answer as Annex II.
10. What documents are required upon actual importation?
Pharmaceuticals and medical materials
Import licences together with import documents a nd analysis certificate of the manufacturer in
the exporting country are required upon actual importation.
Agricultural inputs
Import licenses together with import documents and analysis certificate of the manufacturer in
the exporting country are required upon actual importation.WT/ACC/KHM/17/Rev.1
Page 7
11. Is there any licensing fee or administrative charge ?  If so, what is the amount of the fee or
charge?
Pharmaceuticals and medical materials
In accordance with the new Prakas of Ministry  of Health, No. 794 dated 16 August 2001, which
was immediately entered into force, th e fees for import licence were abolished.
Agricultural inputs
No fee for import license is required.
12. Is there any deposit or advance payment requi rement 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 is required for both import licensing systems.
Conditions of licensing
13. What is the period of validity of a licen ce?  Can the validity of a licence be extended?
How?
Pharmaceuticals and medical materials
A licence is valid for six months and can be extended upon request.
Agricultural inputs
A license is valid for one year and can be extended upon request.
14. Is there any penalty for the non-utilization of a licence or a portion of a licence?
Pharmaceuticals and medical materials
No.
Agricultural inputs
No.
15. Are licences transferable between importers?  If so, are any limitations or conditions
attached to such transfer?
No, licences are not transferable for both import licensing systems.
16. Are any other conditions attach ed to the issue of a licence.
Pharmaceuticals and medical materials
For the importation of psychotropic or narcotic drugs, in addition to the import documentation,
the report on the distribution of drug s previously imported is required.WT/ACC/KHM/17/Rev.1
Page 8
Agricultural inputs
For pesticides, the technical information should be attached with regard to usage, storage,
transport and safety of a product concerned.
Other procedural requirements
17. Are there any other administrative procedures , apart from import licensing and similar
administrative procedures, required prior to importation?
No other administrative procedures are re quired for both import licensing systems.
18. 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 issu ed?  What formalities must be fulfilled for
obtaining the foreign exchange?
For both import licensing systems, foreign exchan ge is not a condition for obtaining a license.
Foreign exchange is freely available.WT/ACC/KHM/17/Rev.1
Page 9
ANNEX I
KINGDOM OF CAMBODIA
NATION - RELIGION - KING
MINISTRY OF HEALTHDEPARTMENT OF DRUGS AND FOOD.
8,Ung Pokun Street ,
Phnom Penh -Carnbodia
Tdl 855- 23 880247-48
Fax 855- 23 880247
NOTES ON THE APPLICATION FOR DRUG REGISTRATION
REQUIRED DOCUMENTATION
1. Application form (refer to Annex I:  Attachment 1)
2. Certificate of a Pharmaceutical Product (CPP) according to WHO format issued by the
competent authority from the country of origin or Free Sale Certificate (only for EU
countries).
3. Certificate of Good Manufacturing Practice  (GMP) according to the WHO recommendations
issued by the competent authority from the country of origin.
4. Scientific documentation in two copies which must include the following data:
4.1 Complete pharmaceutical dossier:
4.1. 1 Qualitative and quantitativeformula (including active ingredient(s) and non-
active ingredients.
4.1.2 Methode of preparation : give a brief description for each stage of
manufacturing with in-process control (including details of batch formula and
batch size.
4.1.3 Analytical control of  Raw Material : (active ingredient(s) and non active
ingredients). The following details must be included:
- Specifications and control methods of analysis or tests should be
provided even if these are derived from Pharmacopoeias (USP, BP,EP...).
- Certificate of analysis of active ingredient with its specifications.
4.1.4 Analytical control of the finished product:
- Specifications and control methods should be provided even if these
are derived from Pharmacopoeias.
- A recent certificate of analysis of the finished product with its
specifications.WT/ACC/KHM/17/Rev.1
Page 10
4.1.5 Stability Test : complete stability study with the following informations:
- Description of method used during the test.
- Batches examined:  number of batches and batch number (a
minimum of two batches are required ).
- Conditions of storage during study.
- Container / packing during study.
- Duration of study.
- Results and conclusions of studies should Justify the proposed shelf-
life printed on the packaging of the concerned product.
4.2. Pre-clinical dossier synthesis of studies are available on:
- Pharmacodynamic,
- Toxicology and
- Pharmacokinetic.
4.3. Clinical dossier:  these documents should be submitted in a summary.  It must be
given with references results of the studies ( Bibliography).
5. Summary of Products Characteristics (S.P.C.)
Detail of informations should be given as stated in Annex I:  Attachment 2.
6. Fee for registration: US$200 for each galeni c form - strength and packing size of the
concerned product.
7. Samples : refer to Annex I:  Attachment 3.WT/ACC/KHM/17/Rev.1
Page 11
 KINGDOM OF CAMBODIA
NATION-RELIGION-KING
MINISTRY OF HEALTH
N.   395              DGH/DDF
IMPORT AUTHORIZATION
Registration No. NCC 015/01
On behalf of the Government of Cambodia, the undersigned empowered by the competent
authority in the meaning of 1971 Convention on Psychotropic Substances and the 1961 Single
Convention on Narcotic Drugs to issue authorization to import such substances , herebyauthorizes the following import by:
Import :(Name): MEDICINS SANS FRONTIERES
( address) : N. 8 St. 211 Sangkat Veal Vong, Khan 7 Makara, Phnom Penh Cambodia
Export form:(Name): MSF Holland
(address): P.O Box 10014, 1001 EA Amsterdam, the Netherlands
Detail of each item imported
Brand Name Generic Name INN Dosage   formNumber of
UnitsTotal quantity
of Substances
and base
1. Codeine Phosphate Codeine Phosphate 30mg/c 500tabs 15gr.
2-Phenobarbital sodium Phenobarbital sodium 200mg/2ml 100Amp. 20gr.
℘℘℘℘℘ two items only ℘℘℘℘℘
Approved bonded warehouse (Name) POCHENTONG International Arport
(address)
This import authorization expires on 30 September 2001 Valid for one shipment only
Date of issue 04 /06/ 01SECRETARY OF STATESignature and Stamp
Dr. UNG PHYRUN
Ministry of Health No. 151-153 Avenue Kampuchea Krom, Fax / phone (855 23) 426841
Department of Drugs and Food: No. 8, St. Ong Pokoun (109) Fax/ Phone (855 23) 880 247, Phnom Penh CambodiaWT/ACC/KHM/17/Rev.1
Page 12
ANNEX I:  Attachment 1
ROYAUME DU CAMBODGE
NATION RELIGION ROI
MINISTERE DE LA SANTEDépartement des Médicaments
et des Produits Alimentaires
8, Vithei Ung Pokun
Phnom Penh - Cambodge
Tél: (855-23) 980247-48
Fax: (S55-23) 880247
APPLICATION FORM FOR MARKETING AUTHORIZATION
A. Information on the Holder of the making Authorization
Name:                                                                                                                  
Address:                                                                                                                  
Phone/Fax:                                                                                                                  
B. Information on the manufacturer
Name:                                                                                                                  
Address:                                                                                                                  
Phone/Fax:                                                                                                                  
C: Information on the product
INN Name:                                                                                              
Commercial Name:                                                                                              
Pharmaceutical Form:                                                                                              
Strength:                                                                                              
D. Qualitative and Quantitative formula
INN name:                                                                                                                  
E. Requested pharmaceutical category
□ Prescription
□ Without prescription
F. Indication, posology and route of administration
- Requested indication
- Recommended posology
- Recommended route of administrationWT/ACC/KHM/17/Rev.1
Page 13
G. Attached information
□ GMP certificate
□ Certificate of a Pharmaceutical Product or Free Sale
Certificate in the country of origin
(only for E.U.Countries)
□ Free Sale Certificate in other countries if available
□ Pharmaceutical documentation
□ Summary of product characteristics
□ Pharmacological documentation: summary
□ Toxicological documentation: summary
□ Clinical documentation: summary
□ Samples: see Annex I:  Attachment 3.
H. Packaging size
- Commercial packing
- Hospital packing
I. Shelf-life
Date                                                                                                                  
Title                                                                                                                  
Name                                                                                                                  
Signature                                                                                                                  WT/ACC/KHM/17/Rev.1
Page 14
ANNEX I:  Attachment 2
SUMMARY OF PRODUCT CHARACTERISTICS
1. Trade name of the Medicinal Product
2. International Non-proprietary Name3. Pharmaceutical form - Strength and Packing size4. Composition : active ingredient(s) and excipients5. Therapeutic properties6. Indications
7. Posology and route of administration
8. Contra-indications9. Warnings and precautions for use10. Drugs interactions11. Pregnancy and lactation
12. Adverse reactions
13. Overdose-Antidote14. Effects on ability to drive and use machine15. Pharmaceutical Particulars
15.1 List of excipients
15.2 Incompatibilities
15.3 Shelf-life
15.4 Special precautions for storage15.5 Nature and content of container
15.6 Instructions for use
16. Dispensation:
□ without prescription
□ with prescription
17. Marketing authorization holder
18. Name and address of the ManufacturerWT/ACC/KHM/17/Rev.1
Page 15
ANNEX 1:  Attachment 3
REQUIREMENT OF DRUG SAMPLES FOR REGISTRATION
Pharmaceutical FormsQuantity for National
Control LaboratoryQuantity for
Registration
Commission(commercial
presentation)Reference Substances
A. ORAL FORMS
- Tablets-Sachets-Capsules. 200 02 Boxes Sufficient quantity or 5
Analysis
- Syrups-Oral Solutions-E lixirs 10 02 Boxes - id -
- Oral Drops 20 02 Boxes - id -
- Ampoules 50 02 Boxes - id -
B. PARENTERAL FORMS
- Ampoules for injection 120 02 Boxes - id -
- Perfusions > 100 ml 10 02 Boxes - id -
- Freeze-Dried Drug-Powder for
injection60 02 Boxes - id -
- Serum-Vaccines. 10 02Boxes -id-
C. LOCAL FORMS
C.1 External use .
- Lotions , Gels , Creams,
Ointments, Liniments , Powder10 02 Boxes - id -
C.2 Transmucous application
- Eye drops, Ophthalmic Ointments,
Nasal drops, Ear drops, AerosolSpray20 02 Boxes - id -
- Suppositories, Ovules,
Gynaecologic tablets200 02 Boxes -id -WT/ACC/KHM/17/Rev.1
Page 16
ANNEX II
SAMPLE APPLICATION FORM FOR IMPORT OF FERTILIZERS
KINGDOM OF CAMBODIA
Nation Religion King
Heng Pich Chhay Import Export Company Ltd.
H.P.C. CO., LTD
#13 Eo., St. 215, Psar Depot III, Toul Kok, Phnom Penh
Tel: (015) 918 423 Fax : (855) 23-880394
II. No. 004/01
______________________________________________________________________________
Date : 30 December 2001
My Name is Pich Chhay, Director of  Heng Pich Chhay Import Export Company
B. Submitted to
H.E. Minister of Agriculture Forestry and Fisheries
Subject: Application for Import Permit of Pestic ides from Abroad in the amount of 6,000 tons
(Six thousands Tons) according to the following specification:
1.  DAP (18-46-0) amount: 2,000 tons
2.  UREA (46-0-0 amount: 2,000 tons
3.  NPK (15-15-15;16-16-813s; 16-20-0) amount: 2,000 tons;
These pesticides were produced in the following countries: the USA, the Russia Federation, the
Philippine and the Republic of Korea and will be imported through Viet Nam crossing the BorderGates of Takeo Province.
I' m very pleased to inform Your Excellency that  in order to participate in the development of
agriculture sector to be grown like other developed countries, my company has a plan to buy foreignpesticides from abroad with the quantities as men tioned above and to supply to the farmers, who are
living in the Provinces throughout the Country in the year 2002.
As requested and the Information provided above, It would be grateful, if Your Excellency
could approve and to issue import permit to my company.
With most respectfully,
Director
Pich ChhayWT/ACC/KHM/17/Rev.1
Page 17
SAMPLE OF IMPORT PERMIT
Kingdom of Cambodia
Nation Religion King
Ministry of Agriculture,Forestry and Fisheries
No. 990 6 March 2002
The Minister of Agriculture,
Forestry and Fisheries
To
H.E. Governor of Pailin Ville
Subject: Proposal to Import 15.000 Tons of Chemical fertilizer from Thailand
Reference: -  Sub-Decree No. 69 dated 28 Octo ber 1998 on Standard and Agricultural Tools
Control;
-  Declaration No. 303  dated 23 Ma y 2001 of the Ministry of Economy and
Finance;
-  Letter No. 34 / 01 dated 7 December 2001 of Pailin Governor;
-  Analyzing Result No. 05/02 S.P.A.L dated 30 January 2002 of Agronomy and
Land Improvement Department;
-  Initial Signature of approval of H.E. Minister of the Ministry of Agriculture,Forestry and Fisheries dated 5 March 2002.
Referring the above Subject and References, I would like to inform Your
Excellency that the Ministry of Agriculture, Forestry and Fisheries has allowed the
Pailin Ville to import Chemical Fertilizers from Thailand through cross-border
Gate............, which comprise of the following types:1- UREA fertilizer ............... Tons (Cow head Trade Mark)
2- 16-20-0 fertilizer ............... Tons (Cow head Trade Mark)
3- 15-15-15 fertilizer ............... Tons (Cow head Trade Mark)
Each import of allowed fertilizers, the Pailin Governor shall inform the Ministry of
Agriculture, Forestry and Fisheries in order to take action and to control the
quality and quantity of the products. This import permit has one year of its validity
from the date of its signature.
Please, accept H.E. Minister, the assurances of my highest considerations.
Seal and Signature
CC:- Agronomy and Land Minister
  Improvement Dept.
- Payline Office of Agriculture,
  Forestry and Fisheries
- Customs and Excise Dept.- Documentation
__________