The Saudi Food and Drug Authority (SFDA) issued infractions to six pharmaceutical facilities for failing to have registered commodities available for the local market or failing to report expected deficits or disruptions in supply.
The SFDA inspectors identified these violations during monitoring and inspection visits in July.
The SFDA has imposed penalties and monetary fines totaling SAR 121,000 to ensure compliance with the Pharmaceutical and Herbal Facilities and Products Law..
"Riyadh, August 14, 2024." The Saudi Food and Drug Authority (SFDA) issued infractions to six pharmaceutical facilities for either failing to have registered commodities available for the local market or failing to report an expected deficit or disruption in supply. The problem stemmed from both of these violations.It was informed by the SFDA that its inspectors had spotted the facilities that were in violation of the law during the ongoing monitoring and inspection visits that took place in July. In order to ensure compliance with the Pharmaceutical and Herbal Facilities and Products Law and its Implementing Regulations, the Saudi Food and Drug Administration (SFDA) has announced that it has issued penalties and monetary fines totaling SAR 121,000.Manufacturers and warehouses of pharmaceutical and herbal products are required by law to maintain a permanent stock of all registered preparations that is sufficient for a period of six months. The SFDA must validate the consumption data and annual demand for this stock. In the event that the SFDA does not decide when to delete the registered items, the law mandates that producers and warehouses must compensate for any stock shortages within a period of three months.Law requires manufacturers and warehouses of pharmaceutical and herbal products to notify the Food and Drug Administration (SFDA) of any anticipated shortage or disruption in the supply of registered items for at least six months from the anticipated date of the shortage. Furthermore, they are required to come up with suggestions that help make up for the deficiencies. In addition to the plant being shut down or having its license revoked, the imposition of penalties can reach as high as five million Saudi riyals.The Food and Drug Administration (SFDA) strongly encourages customers to report facility violations by calling the unified number 19999.