Fines of 4 million riyals imposed on facilities that violated the drug monitoring and availability system
The Saudi Food and Drug Authority (SFDA) announced strict penalties against 34 pharmaceutical establishments found to be in violation of regulations, with fines totaling over SAR 4 million (specifically SAR 4,175,400). These penalties resulted from these establishments' failure to comply with drug availability regulations and their non-compliance with registration and reporting requirements through the approved electronic drug tracking system, "Rasad," during the month of January.
Details of observed violations
The authority's monthly report revealed the variety of violations that warranted these substantial fines, with 13 facilities topping the list for failing to comply with the early notification mechanism regarding anticipated shortages or disruptions in drug supplies. The regulations stipulate that notification must be submitted at least six months prior to the expected disruption, a crucial measure to ensure continuity of treatment for patients.
The inspection teams also identified 11 other facilities that failed to provide their registered products in the Saudi market, regardless of demand or price, thus violating their obligations to supply medication. In a related matter, penalties were imposed on eight facilities that failed to report directly and accurately on the movement of medication within the supply chain, which compromises the accuracy of electronic tracking data and the governance of pharmaceutical inventory. Additionally, two facilities were penalized for not maintaining a permanent stock sufficient for six months and for failing to replenish shortages within the legally mandated timeframe.
The importance of the "monitoring" system and drug security
The electronic monitoring system is one of the most important strategic national projects adopted by the Kingdom to enhance public health. The system aims to track human medicines from the production line at the factory until they reach the consumer, using the latest global technologies. Its importance lies in combating commercial fraud, preventing the circulation of expired or counterfeit medicines, and ensuring the availability of accurate data on pharmaceutical stocks in all regions of the Kingdom, thus facilitating rapid decision-making in cases of crises or supply shortages.
Consumer protection and market stability
These intensified regulatory measures are part of the Saudi Food and Drug Authority's commitment to protecting public health and ensuring patients' right to safe and continuous access to medication. Manipulating drug availability or related data poses a direct threat to public health security, particularly concerning medications for chronic diseases and critical conditions. The Authority regularly reviews supply chains to ensure that all parties—manufacturers, distributors, and pharmacies—comply with the stringent standards mandated by Saudi regulations.
Deterrent penalties that can include license revocation
The Saudi Food and Drug Authority (SFDA) has warned that lax enforcement of regulations could subject establishments to harsher penalties in the future. According to the Pharmaceutical Establishments and Products Law, fines can reach up to 5 million riyals for each violation. The measures are not limited to financial penalties; they may also include 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 that threaten patient safety. The SFDA emphasized that it will not hesitate to apply the maximum penalties to deter violators.
