SFDA Penalizes Six Facilities For Failing To Maintain Drug Stock Levels

The Saudi Food and Drug Authority (SFDA) has identified violations in six pharmaceutical facilities. These facilities either failed to keep registered products available for the local market or did not report an anticipated shortage or supply interruption.

SFDA inspectors discovered these violations during their ongoing monitoring and inspection visits in July. The authority imposed penalties and financial fines exceeding SAR 121,000 on the offending facilities. This action was taken under the Pharmaceutical and Herbal Facilities and Products Law and its Implementing Regulation.

According to this law, manufacturers and warehouses of pharmaceutical and herbal products must maintain a permanent stock of all registered preparations sufficient for six months. This requirement is based on consumption data and annual demand reviewed by SFDA.

The law mandates that manufacturers and warehouses inform SFDA if they expect a shortage or interruption in supply for at least six months before the expected shortage date. They must also provide solutions to address the shortage. Failure to comply can result in penalties up to 5 million Saudi riyals, facility closure, or license cancellation.

Unless SFDA decides to cancel a registered product, manufacturers and warehouses must compensate for any stock shortages within three months. This ensures that there is no disruption in the availability of essential pharmaceutical and herbal products.

Consumer Reporting Mechanism

The SFDA encourages consumers to report any violating facilities by calling the unified number 19999. This initiative aims to ensure compliance with regulations and maintain the availability of necessary products in the market.

The SFDA's actions highlight its commitment to ensuring that pharmaceutical facilities adhere to regulations, thereby safeguarding public health by maintaining a steady supply of essential medicines.

With inputs from SPA