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Procedure NameApplication for Pharmaceutical Manufacturing License
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 Cosmetics

 

This document shows application process for License for Pharmaceutical Manufacturing Plant.

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 Cosmetics, 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.

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Supporting Documents include:

  • Certificate of good manufacturing practice
  • Pharmacist Certificate for the main technical pharmacist in charge of the establishment
  • Applicant resume (have sample at MoH)
  • Applicant Health certificate
  • Letter of non-guilt (certified by Ministry of Ministry of Justice)
  • Drawings of establishment, including location mapping, office and storage building, certified by local authority
  • Applicant Photos

 

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

Licensing service fee is 4.000.000 KHR. All service fee at MoH is 30% cheaper for the license/certificate validity renewal.

Note 5

The license is valid for 2 years (validity shown on the license document 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 license. 

 

CategoryProcedure

The following form/s are used in this procedure
TitleDescriptionCreated DateUpdated DateIssued By
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This procedure applies to the following measures
NameMeasure TypeAgencyDescriptionCommentsLegal DocumentValidity ToMeasure Class
License requirement for manufacturing plant of pharmaceuticals, including plants which import raw material for pharmaceutical productionAuthorization RequirementMinistry of HealthAll pharmaceutical plants (including plants that import raw materials for pharmaceutical production) require permit from Ministry of HealthTo govern all pharmaceuticals in CambodiaLaw on the Management of Pharmaceuticals31-12-9999Good