1. Pharmaceutical Establishments may not import controlled materials and products or their raw materials or pharmaceutical raw materials for their active ingredients except after the approval of the EDE based on a request submitted to it and signed by the licensed Pharmacist Responsible for managing the Pharmaceutical Establishment, which includes all details related to the controlled materials and products to be imported, their quantities and types, the State of export, as well as the method of shipping them, and the approved clearance center in the State. 2. The Executive Regulations of this Decree-Law shall determine the controls for customs clearance of these materials.
Interpretation and application must be checked against the official text and current version.