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 ask permission from the Ministry of Health to open a manufacturing facility and a pharmaceutical export and import institution in Cambodia.Licensing of the establishment of a manufacturing facility and a pharmaceutical export institution is a requirement before being eligible for pharmaceutical trade, such as import or export, stock, wholesale to legal pharmacies (serum and vaccine) all types for health, including medical equipment and dentists such as equipment, implants, disinfectants and programs that serve in the health sector. Foreign pharmaceutical establishments must also make a pre-registration before being able to obtain import their pharmaceutical products into the Cambodian market. Pharmaceuticals and herbal remedies, including equipment and dentists, are allowed to export and imports must be registered first.Similarly, for the business of exporting and importing cosmetic products, it is necessary to have a license to open a cosmetics import and export and register the cosmetic products that will be imported and exported first. This document shows the procedure for applying for a cosmetic certificate.

Place for submitting application

The One Window Service “OWSO” is located in the Ministry and has officials from specialized departments such as the Department of Medicine, Food, Medical Equipment, and Cosmetics on duty to provide services related to their units. Applicants can also contact the specialized department located in the same Ministry.Department of Medicine, Food, Medical Equipment, and CosmeticsThe 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
  • Email: webmaster@moh.gov.kh
  • Website: www.moh.gov.kh

Contact health officials

  • Phone: (855-23) 885-970 / 884 909

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Notes

Note 1

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 for 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 cosmetic registration:

  • Product formula by specifying the name, a quantity of storage substance
  • How to control chemicals with a quality control certificate
  • Conditions for the analysis of microorganisms in cosmetic products and the purity of chemicals, as well as control methods in response to these conditions.
  • Specification of Ingredients and Finished Products
  • How to produce that follows the principles of good production in the cosmetics
  • Cosmetic efficiency data
  • Evaluation documentation on product safety, completion, and determination of external impact on the human body
Note 3

The implementation of the internal procedures is started from the specialized office and goes through a number of hierarchies as defined in the law. Before reaching any decision, the expert official may contact the applicant directly for any necessary supplement required for the adequacy of the request, such as requiring the applicant to submit 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 80,000 Riels for the registration of cosmetics, which is valid for 2 years, and for the request for renewal, the Ministry sets the service fee of 70% of the original service fee.

Note 5

There are a number of cases where the applicant is told to obtain a license from the department itself. Applicants should come with an ID or other credentials along with a receipt of a word/receipt.