Saudi Arabia Adds New Regulations on Drugs
The Saudi Food and Drug Authority has set strict new requirements for the import, clearance and export of commercial and investigational drugs, including provisions on drugs for compassionate use and drugs meant for use in clinical trials.
Drugs for use in clinical investigations must have SFDA approval before they can be imported into the country. A letter from the sponsor to the agency should explain the purpose of the study, the nature of the drug or drugs, the concentration and pharmaceutical form, the quantity, unit and size involved, the name and nationality of the manufacturer, and the importer’s name.
Commercial drug products must comply with Saudi labeling and packaging requirements and the labeling must be in Arabic. As with investigational drugs, shipments must include a letter stating why the clearance is needed, the name of the arrival port, the importer’s name, the product’s name, concentration and quantity, the manufacturer’s name and nationality and the original invoice.
The regulations outline similar requirements for the importation of active pharmaceutical ingredients, drug samples and drugs imported for educational purposes.
Drugs may enter the country only through SFDA-approved ports and must be transported in refrigerated containers. Data loggers and their serial numbers must be included in the shipments. Following inspection, the shipment should be transported and stored according to the manufacturer’s recommended conditions. Temperature records must be presented to inspectors upon request.
Requests to export drugs should be submitted directly by the manufacturer in a letter containing the product’s name, registration number, quantity, batch number, total value, transportation process, exporting port and a copy of the manufacturer’s license.
Regulation and Requirements for Import, Clearance and Export is available at www.fdanews.com/5-15-SFDA-1.pdf. Read Regulations of Transporting and Storing Medication and Pharmaceutical Products through Customs Ports at www.fdanews.com/5-15-SFDA-2.pdf. — Jonathon Shacat