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.