Application for Pharmaceutical Manufacturing License
Procedure Name
Application for Pharmaceutical Manufacturing License
Description
Description
According to the Law on Pharmaceutical Management and Law on Amendment of Law on Pharmaceutical Management, Cambodian citizens of either sex or foreigner have the right and may request permission from the Ministry of Health to open manufacturing establishments and pharmaceutical importers in Cambodia.
Having a license to open a manufacturing facility and a pharmaceutical import or export institution is a prerequisite for obtaining the right to trade in medicines, such as importing or exporting wholesale stocks to legal pharmacies of all kinds of medicines and vaccines (serum, vaccine) for the health sector, including medical and dental equipment such as material, equipment, instrument, implement, appliance, apparatus, implant, machine, disinfectant, in vitro reagent and calibrator, and software that serves the health sector. Meanwhile, foreign pharmaceutical companies must also pre-register before obtaining permission to import their pharmaceutical products for distribution in the Cambodian market.
Medicines, vaccines, and medical and dental equipment allowed to be imported and exported must first be registered.
Similarly, for exporting and importing cosmetic products, it is necessary to have a license to open cosmetics import and export business to import the cosmetic products to be imported and exported first.
This document shows the procedure for applying for a license to open a pharmaceutical company.
Place for submitting application
The One Window Service “OWSO” is located in the Ministry's office, with officials from specialized departments such as the Department of Medicine, Food, Medical Equipment, and Cosmetics on a regular basis to provide services related to their unit. Applicants can also contact the specialized department located in the same Ministry.
Department of Medicine, Food, Medical Equipment, and Cosmetics
The Ministry of Health
Address: Office of the Ministry of Health, Lot 80, Samdech Pen Nuth Street (289), Sangkat Boeung Kak II, Khan Toul Kork, Phnom Penh
Applicants can contact the OWSO to request a sample application. In some cases where there is no official at the OWSO, applicants can contact the Department of Drugs, Food, Medical Equipment, and Cosmetics directly to request a sample application or through the website: Department of Drugs and Food (ddfcambodia.com)
Note 2
Applicants may appoint a representative to apply but must have a power of attorney or letter of introduction.
Attachments for requesting to open these pharmaceutical companies include:
Certificate of Good Practice in Production
Pharmacist certification recognized by the Ministry of Health
Resume of the applicant (sample)
Health certificate issued by the Ministry or Department of Health
A letter of conviction issued by the Ministry of Justice
At least 5 office and warehouse location diagrams
3 photos of the person concerned
Note 3
The implementation of internal procedures is started from the specialized office and goes through a number of hierarchies as defined in the law. Prior to reaching a decision, the specialist officer may contact the applicant directly to obtain any necessary additions for the adequacy of the request, such as requiring the applicant to provide additional documents to the expert officer.
Note 4
After issuing the approval decision on the application, the professional officer will contact the applicant to pay the service fee.
The service fee is 4 million riels for the issuance of a new institution license, which is valid for 2 years, and for the application for renewal, the Ministry sets the service fee at 70% of the original service fee.
Note 5
There are some cases where the applicant is told to get the license directly from the department. Applicants should bring their ID card or other identification along with their receipt/payment receipt.
