Application for Visa Registration Certificate for Medicines

• 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

Applicants may 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 Drags, Food, Medical Equipment, and Cosmetics directly to request a sample application or through the website: Department of Drugs and Food (ddfcambodia.com)

Applicants may appoint a representative to apply but must have the power of attorney or a letter of introduction.

Attachments for modern medicine visa (domestic goods) ៖

• Summary of medicinal characteristics (sample)
• Medicinal documents
• Summary of Energy Medicine, Summary of Scientific Documents and Summary of Clinical Documents
• Sample medicine
• Registration fee ($ 100 for one item)

Attachments for registration of medicines (Before import):

• Certificate of Competency, Productivity of the country of production according to the conditions set by the World Health Organization.
• Business license in the country of manufacture.
• Certificate of Business Authorization in the Market of Other Countries (If).
• Summary of pharmaceutical characteristics (There is a sample of)
• Pharmaceutical documentation
• Pharmaceutical Energy Documentation Summary, Summary, and Summary Clinical Documents
• Sample medicine

Attachments for registration of traditional pharmaceutical visas (domestic goods):

• Summary of pharmaceutical characteristics (There is a sample of)
• Pharmaceutical documentation
• Summary clinical documentation
• Sample medicine

Attachments for the registration of imported herbal remedies, plants or animals or plants that have not yet been processed or processed in a simple method:

• Export permit of the exporting country
• Pharmaceutical documents to be specified in the original language, the name in Latin and the source, Therapeutic characteristics, Processing method, how to maintain, expires to use.
• Sample medicine

Attachments for Imported Pharmaceutical Registry which is a type of product composed of one or more substances

• Certificate allowed to sell (Original law or certified copy of competence) Issued by the competent authority of the manufacturing country
• Certificates permit production issued by the competent authority of the manufacturer or certificate of good performance in production (If)
• Pharmaceutical List Certificates in Other Countries (If)
• Summary of pharmaceutical characteristics (There is a sample of)
• Pharmaceutical documents to specify the name, quantity and function in the formula, Description of composite components, production methods and quality control methods of finished products, how to maintain, expires to use.
• Clinical documentation

Attachments for visa registration, Health assistance is used on the outside human body:

• Authorization law opens a manufacturing facility
• The formula specifies the name and quantity
• Purpose of use
• Caution in use
• 2 sample products

Attachments for visa registration, Health assistance is used on the outside human body Import from abroad:

• Certificate of sale in the country of production (Original or copy of the country’s authority to produce)
• Certificate of authorization issued by the competent authority of the manufacturer or certificate of good practice in production (Original or Copy of the competent authority of the country producing)
• Summary of product characteristics
• The formula specifies the name and quantity
• Describe each component
• Product quality control securities issued by the manufacturer country
• 2 sample products

Attachments for visa registration, list of pharmaceuticals or health supplements:

• Certificate of authorization issued by the competent authority of the manufacturer or certificate of good practice in production (Original or Copy of the competent authority of the country producing)
• Certificate of sale on the market (Original or copy of the country’s authority)
• Summary of product characteristics
• The formula specifies the name and quantity
• Product quality control securities issued by the manufacturing facility
• How to maintain and order the duration of the expiration of the time of use
• 2 sample products

The implementation of internal procedures is started from the specialized office and goes through a number of hierarchies as defined in the law. Before reaching any decision, a professional 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.

Following the issuance of the permit decision on the application, the professional officer will contact the applicant to pay the service fee។ One million riel service fee for visa registration, valid list of five years and 400,000 riel for visa registration, list of traditional medicines, health supplements and health assistance products used on the external person, valid for three years. For renewal request, the Ministry determines the fee of 70% of the original service value.

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.