Food and Drug Authority: Fines of 4 million riyals imposed on 34 facilities that violated the monitoring system
In a decisive move aimed at enhancing pharmaceutical security and protecting public health in the Kingdom, the Saudi Food and Drug Authority (SFDA) announced the imposition of hefty fines on 34 pharmaceutical establishments following the detection of a series of serious violations during January. The total value of the fines levied amounted to SAR 4,175,400, resulting from these establishments' failure to comply with drug availability regulations and their non-compliance with the approved electronic tracking system, "Rasad.".
Details of violations and their distribution across establishments
The Authority's monthly report revealed the variety of violations that warranted these deterrent penalties, with 13 facilities topping the list for failing to comply with early notification protocols. Regulations stipulate that the Authority must be notified of any anticipated shortages or disruptions in drug supplies at least six months prior to the expected crisis, a requirement these facilities disregarded, thus jeopardizing the stability of the pharmaceutical market.
In a related development, inspection teams identified 11 other facilities that failed to provide their registered products in the Saudi market, disregarding their obligations to supply medication to patients regardless of economic feasibility or consumption rates. Penalties also included eight facilities that failed to report directly and accurately on the movement of medications within their supply chains, negatively impacting the accuracy of electronic tracking data and inventory management. Additionally, two facilities were penalized for not maintaining a permanent stock sufficient for six months.
The "Monitoring" system: a cornerstone of pharmaceutical security
This decisive move comes as part of the Authority's efforts to enforce compliance with the electronic tracking system "Rasad," one of the most important national digital projects in the health sector. This system aims to track and trace all human medicines from the moment they leave the factory until they reach the consumer. Its importance lies in its ability to combat commercial fraud, prevent the circulation of expired or counterfeit medicines, and ensure the rapid and efficient recall of defective batches when necessary.
Deterrent penalties that can include license revocation
The Saudi Food and Drug Authority (SFDA) emphasized that these measures are not merely financial penalties, but rather a clear message to all those working in the sector. The SFDA confirmed that the regulations governing pharmaceutical establishments and products allow for harsher penalties in cases of repeated or serious violations, with fines potentially reaching 5 million riyals. Furthermore, the measures do not stop there; they may extend to the temporary closure of the pharmaceutical establishment for up to 180 days, or even the permanent revocation of its license, to ensure zero tolerance for any actions that threaten public health and safety.
