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Procedure NameApplication for Visa Registration Certificate for Medicines
Description

Description

The Law on Management of Pharmaceuticals and Law on the Amendment of Law on Management of Pharmaceuticals stipulate the requirement to have permission/authorization from Ministry of Health (MoH) to run pharmaceutical manufacturing establishment, or importing/exporting establishment.

Being licensed by MoH, the company can conduct all business activities pertaining to production, storage, distribution and wholesale, and importation and exportation of pharmaceutical products as well as medical equipment, which in turn may include material, equipment, instrument, implement, appliance, apparatus, implant, machine, disinfectant, in vitro reagent and calibrator, and software that are used for health sector in Cambodia. Similar licensing scheme also applies to cosmetics importing/exporting companies.

Pharmaceutical product import/export companies will also need to register foreign pharmaceutical manufacturing plants so that the company can bring in the products produced by the plants.

It is also required that pharmaceutical and cosmetic products, and medical equipment’s be registered and receive registered number from MoH before being allowed to distribute, import and export.

So, to be able to import/export pharmaceutical product or cosmetic products or medical equipment, applicant must first consider applying for some of the following prerequisite authorization from MoH before requesting for import/export authorization, also from MoH.

•      License for Pharmaceutical Manufacturing Plant

•      Pharmaceutical Importer-Exporter License

•      Registration Certificate of Pharmaceutical Manufacturer from Overseas

•      Cosmetics Importer-Exporter License

•      Visa Registration Certificate for Medicines

•      Visa Registration Certificate for Medical Equipment

•      Visa Registration Certificate for Costmetics

 

This document shows application process for Visa Registration Certificate for Medicines. This application process applies to either modern or traditional medicine, health supplements, and other kinds of medicines used on outer of human body.

Place for submitting application

MoH has one Single Window to serve the need of applicant with regards to all kinds of public services the ministry provides, including CLP issuing service.

Single Window across government ministries is basically stationed with administrative or technical staffs of relevant departments inside the ministry. MoH’s Single Window is no exception; it has staffs from Dept. of Drugs, Food, Medical Equipment and Costmetics, who is the ministry’s technical department in charge of issuing all types of license and certificates above. Applicant comes to Single Window to inquire about the service, get sample application forms, submit, pay fee, and collects the requested all types of authorization documents.

Practically, there are chances that applicant may not see the relevant staffs there for some reasons. In this case, applicant can go directly to the Dept. of Drugs, Food, Medical Equipment and Costmetics, which is also located inside the ministry.

 

Address for Dept. of Drugs, Food, Medical Equipment and Costmetics (DDFC):

 

Ministry of Health

Address: #2 St. Samdach Pen Nuth, Sangkat Beoung Kak 2, Khan Tuol Kok, Phnom Penh, Cambodia.

1st Person of Contact Name: Mr. Ouk Sophal, D-DIR of DDFC

1st Person of Contact Tel: (855) 17 678692

2nd Person of Contact Name: Ms. Nouv Phalla, D-DIR of DDFC

2nd Person of Contact Tel: (855) 12 671314

Website: http://www.moh.gov.kh/



Notes

 

Note 1

Applicant can get sample application form at Single Window

Note 2

Applicant can assign a representative to submit application and go through the required application process on his behalf. In this case, Power Attorney or authorization letter is also needed to include into the application.

Supporting document for registering locally produced modern medicine:

·        Resume Des Charactestiques du product (have sample at MoH)

·        Document phamaceulique

·        Document phamaceulique en resume, Document toxicologique en resume, Document Clinique (if have)

·        Samples of medicine applied

 

Supporting document for registering modern medicine before its import៖

·        WHO Prequalification documents issued in the producing country

·        Authorization to distribute in markets of producing country

·        Authorization to distribute in other markets (if have)

·        Resume Des Charactestiques du product (have sample at MoH)

·        Document phamaceulique

·        Document phamaceulique en resume, Document toxicologique en resume, Document Clinique (if have)

·        Samples of medicine applied

 

Supporting document for registering locally produced traditional medicine:

·        Resume Des Charactestiques du product (have sample at MoH)

·        Document phamaceulique

·        Document clinique

·        Samples of medicine applied

 

Supporting document for registering (natural, unprocessed, or processed with simple methods) traditional medicine to be imported:

·        Export authorization document issued by exporting country

·        Documents about medicine, which detail original name, Latin name, origin, processing methods, storage method, expired date

·        Samples of medicine applied

 

Supporting document for registering processed traditional medicine to be imported:

·        Authorization to produce, issued by producing country, or Certificate of good manufacturing practice (if have)

·        Free sale certificate (authorization to distribute) issued by producing country

·        Manufacturer Registration Certificate, issued by countries other than producing country

·        Resume Des Charactestiques du product (have sample at MoH)

·        Documents about medicine, which detail original name, Latin name, origin, materials used in the processing, processing methods, storage method, expired date

·        Document clinique

·        Samples of medicine applied

 

Supporting document for registering locally produced medicines used on outer of human body:

·        Authorization to open pharmaceutical establishment

·        Documents detailing specification and amount/weight, using purpose, use warning

·        Samples of medicine applied

 

Supporting document for registering importing medicines used on outer of human body:

·        Free sale certificate (authorization to distribute in markets), issued by producing country

·        Authorization to produce, issued by producing country, or Certificate of good manufacturing practice (if have)

·        Resume Des Charactestiques du product (have sample at MoH)

·        Documents detailing materials used and medicine specification and amount/weight

·        Product quality certification, issued by producing country

·        Samples of medicine applied

 

Supporting document for registering locally produced or importing health supplement៖

·        Free sale certificate (authorization to distribute in markets), issued by producing country

·        Authorization to produce, issued by producing country, or Certificate of good manufacturing practice (if have)

·        Resume Des Charactestiques du product (have sample at MoH)

·        Documents detailing specification and amount/weight, storage method and expired date

·        Product quality certification, issued by producing country

·        Samples of medicine applied

 

If applicant submits copied version of any supporting documents that is relevant to applicant’s identification, it is normal requirement that these copied documents be certified by competent authorities first.

Note 3

Internal process starts from technical office inside the department and go through several consideration and approval process by relevant officers/offices in institutional hierarchy order.

During this internal process, applicant may be asked or advised (practically by phone call) by officer to provide further information and/or documents for the completeness of application.

This process would results in primary approval on the application and only then technical officer in charge of the application may advise applicant about this primary approval and ask applicant to come to pay required service fee.

Note 4

Registration service fee is 1.000.000 KHR for modern medicine and 400.000 KHR for traditional medicine, health supplements, and other kinds of medicines used on outer of human body.

All service fees at MoH are 30% cheaper for the license/certificate validity renewal.

Note 5

The registration certificate is valid for 5 years for modern medicine and 3 years for traditional medicine, health supplements, and other kinds of medicines used on outer of human body (validity shown on the certificate itself).

Applicant may be advised to come directly to the technical department to collect the license. Applicant may bring identification documents of himself and application filing receipt/payment receipt when he comes to collects the certificate. 

 

CategoryProcedure

The following form/s are used in this procedure
TitleDescriptionCreated DateUpdated DateIssued By
Form used for visa registration application for health supplement04-04-201504-12-2015Ministry of HealthThis is Dowload File
Form used for visa registration application of medicine04-04-201504-12-2015Ministry of HealthThis is Dowload File
Form used for visa registration application of medicines used on outer of human body04-04-201504-12-2015Ministry of HealthThis is Dowload File
This procedure applies to the following measures
NameMeasure TypeAgencyDescriptionCommentsLegal DocumentValidity ToMeasure Class
Requirement for visa for and registration of medicinesRegistration RequirementMinistry of HealthVisa for and registration of medicines aim to control the production, import, export and trading of medicines in Cambodia to ensure the quality of medicines and production rights of manufacturersTo control the production, import, export and trading of medicines. To ensure quality of medicines and production rights of manufacturers Prakas No. 364 on the Implementation of Visas for and Registration of Medicinces31-12-9999Good
Requirement for visa registration on imported medicines for sale in CambodiaRegistration RequirementMinistry of HealthImported medicine can be displayed for sales only if they have registration approved by MOHTo control the import and trading of medicines in CambodiaSub-Decree No. 044 on Visa-Registration of Medicines the Royal Government of Cambodia 31-12-9999Good