RIYADH: The Saudi Food and Drug Authority (SFDA) has announced violations against six pharmaceutical companies that failed to have registered products available for the local market or did not report an expected shortage or interruption in supply, the Saudi Press Agency (SPA) reported.
The SFDA said that its inspectors noted the violations during continuous monitoring and inspection visits in July. The authority pointed out that it imposed penalties and fines exceeding SAR 121,000, in accordance with the Pharmaceutical and Herbal Facilities and Products Law.
As per 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 yearly demand reviewed by the authority.
The law requires manufacturers and warehouses to address any shortage in stock within a maximum of three months unless a decision is issued by the authority to cancel the registered product.
The law says that pharmaceutical and herbal product manufacturers and warehouses are required to inform the authority of an expected shortage or interruption in the supply of the products for a period of not less than six months from the expected shortage date. They are also required to provide solutions to compensating for the shortage.
The penalties can reach up to 5 million Saudi riyals, in addition to closing the facility or cancelling the license. The authority asks consumers to report violating facilities by calling the unified number 19999.
