Regulations for the Inspection and Examination of Imported Medicaments Article 18

For inspection of medicaments, that are difficult to sample in a container yard, require five or more days for examination at the laboratory, perishable, or lack stability on safety efficacy, the inspection authority shall issue a Notice of Prior for Import for custom clearance after the obligatory inspection applicant declares to bear the responsibility for the safety and storage of products imported with an Affidavit. The inspection authority may issue a Notice of Prior Release for Import for customs clearance since the necessity of examination.If the pledged storage location does not conform to the actual storage location, or medicaments are put to use before receiving the import permit, the inspection authority may temporarily suspend acceptance of an application for prior release of imports by the obligatory inspection applicant for a period of 180 days.