Manufacturer Registration Process: For medicines, normally the importer has to sign an agreement with its principal suppliers or manufacturers, so if the items the importer want to order belongs to them, then the importer just places the order directly to that particular supplier/manufacturer. In the case of this BPA, the importer acts as the exclusive local distributor for the manufacturer’s medicines. The manufacturer is required first to send medicine samples to the importer for the latter to initiate the registration process. The importer then submits the samples and other supporting documents (factory, production, clinical study, and any other related document required by Ministry of Health) to the Drug and Food Department of the Ministry of Health, which is the agency responsible for the registration. Provided all the conditions are met and are satisfactory to the MoH, the registration process takes nearly one year to complete. Procedures for Manufacturer registration: 1. Generally, a manufacturer of pharmaceutical products would prefer to have their manufacturing facilities registered first. However, it does not need to wait for the completion of the manufacturer registration to submit our procedures of drug registration. It can do so after making the initial payment, the receipt of which can be used to lodge the application for drug registration. 2. The manufacturer is required to submit samples of every product which is the subject of a registration for testing by the National Laboratory.

1. The importer completes the clearance documents and pass to registration sector for import permit at the Medicine Department of MOH. Then the importer passes on the clearance documents to the clearance agent to start the clearance process. 2. The importer or his clearance agent lodges with the Customs Office three copies of the declaration with supporting documents such as Commercial Invoice, Packing List, Bill of Lading, Import license. The Declaration information is validated and scrutinized. The Camcontrol form is also attached to the declaration. 3. For shipment with full duties and taxes payment, it takes the Customs office 3 days to do price evaluation for shipment of medical equipments and 2 to 3 days for shipment of medicine, re-agent, chemical and disposable. It takes another 1-2 days to obtain a Customs Permit from the Customs office. 4. The importer then does a follow-up with clearance agent on the declaration value and the tax payment rate. He then prepares a tax payment cheque for the clearance agent, who pays the duties and the taxes either at the port or at the treasury in Phnom Penh which in turn issues a receipt. For shipment under tax exemption, the clearance agent uses the letter for pre-clearance issued by MoH to apply for customs import permission at customs office. 6. The Customs Examination Team inspects the goods simultaneously with Camcontrol.