Request import quota and permission

Activities and Associated Documentary Requirements: 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.