Saudi drug authority fines 6 pharma companies for violating stock, supply regulations

The Saudi Food and Drug Authority has announced violations against six pharmaceutical facilities that failed to have registered products available for the local market or did not report an expected shortage or interruption in supply.

The authority said that its inspectors identified the violations during monitoring and inspection visits in July, the Saudi Press Agency reported.

The authority stated that it imposed penalties and financial fines exceeding SR121,000 ($32,000), in accordance with the Pharmaceutical and Herbal Facilities and Products Law and its implementing regulations.

According to the law, manufacturers and warehouses of pharmaceutical and herbal products must maintain a permanent stock of their registered preparations sufficient for a period of six months, based on consumption data and annual demand reviewed by the authority.

Unless a decision is issued by the authority to cancel the registered product, the law requires manufacturers and warehouses to address any shortage in stock within a maximum of three months.

The law stipulates that pharmaceutical and herbal product manufacturers and warehouses are obligated to inform the authority of an expected shortage or interruption in the supply of registered products for a period of not less than six months from the expected shortage date. They are also required to provide solutions that contribute to compensating for the shortage.

Penalties can reach up to SR5 million, in addition to the facility being closed or its license being canceled. The authority urges consumers to report violating facilities by calling 19999.