Food and Drug Authority: Fines totaling 4 million riyals imposed on 34 violating establishments
The Saudi Food and Drug Authority (SFDA) announced that it has taken decisive action against several violating pharmaceutical establishments, imposing fines totaling over SAR 4 million on 34 facilities during January. These penalties stem from the establishments' failure to comply with drug availability regulations and their non-compliance with the approved electronic tracking system, "Rasad," reflecting the SFDA's commitment to regulating the pharmaceutical market in the Kingdom.
Details of violations and financial penalties
The Authority's monthly report revealed numerous violations, with fines totaling SAR 4,175,400. Thirteen establishments topped the list of violations for failing to report anticipated shortages or disruptions in drug supplies in advance, disregarding the legal requirement to report at least six months prior to the expected disruption. The inspection teams also identified 11 other establishments that failed to ensure the availability of their registered products in the market, and eight establishments that failed to provide direct and accurate reporting on drug movement within the supply chain. Additionally, two establishments were penalized for not maintaining a six-month supply of essential medications.
The "Monitoring" system and its importance in drug security
The electronic tracking system, "Rasad," is one of the most important national initiatives launched by the Kingdom to enhance public health. The system aims to track all human medicines from the moment they leave the factory until they reach the consumer, utilizing the latest technologies. Its importance lies in ensuring drug safety, combating commercial fraud, and preventing the circulation of expired or counterfeit medications. Adherence to this system is a cornerstone of the Kingdom's pharmaceutical security strategy, as it enables regulatory authorities to accurately determine the availability and quantities of medicines, thus facilitating proactive crisis management and addressing supply shortages.
Consumer protection and market stability
These stringent measures underscore the Authority's commitment to prioritizing product safety and quality. Neglecting medication availability or manipulating tracking data is not merely an administrative violation; it poses a direct threat to the health of patients who depend on the continuous and safe availability of their medications. This oversight positively impacts the local market by fostering trust between consumers and the pharmaceutical sector, and ensuring patients receive their right to treatment without obstacles or unexpected interruptions.
Deterrent penalties that can include license revocation
The Saudi Food and Drug Authority (SFDA) strongly warned that penalties under the regulations governing pharmaceutical establishments and products are not limited to current fines, but can reach up to 5 million riyals to deter any negligence that jeopardizes public health. The SFDA indicated that regulatory measures may extend to the temporary closure of the pharmaceutical establishment for up to 180 days, or even the permanent revocation of its license in cases of serious violations and repeated offenses. The SFDA urged all establishments to fully comply with regulations to ensure the sustainability of their operations and the safety of patients.
