The Saudi Food and Drug Authority (SFDA) has imposed fines totaling SR678,400 on 24 pharmaceutical companies for failing to comply with various regulatory requirements, particularly in ensuring the availability of their registered products in the local market.
The violations primarily involved a failure to report to the SFDA’s Drug Track and Trace System (RSD), neglecting to inform the authority of anticipated shortages or supply disruptions, and failing to maintain adequate stock levels of registered products.
According to the SFDA, the infractions were identified during routine inspections conducted last month. Among the 24 firms, five were penalized for failing to report to the RSD, nine for not providing their registered products, nine for not reporting anticipated shortages or supply interruptions, and one for failing to maintain a sufficient stock of its registered products for a minimum of six months.
These penalties were issued under the “Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and Their Products Guideline.” The guidelines mandate that pharmaceutical and herbal product manufacturers, as well as warehouses, must maintain a six-month stock of their registered products based on data reviewed by the SFDA regarding annual consumption and demand. In cases of stock shortages, companies are required to resolve the issue within a maximum of three months, unless the SFDA cancels the product registration.
The guidelines also require pharmaceutical manufacturers and their representatives to notify the SFDA of any anticipated supply disruptions at least six months in advance and propose solutions to mitigate the impact of such shortages.
The SFDA emphasized that these measures are part of its commitment to ensuring that pharmaceutical establishments adhere to the necessary regulations, ultimately securing the availability of essential medicines for citizens and residents in Saudi Arabia.
The authority warned that penalties under the guideline could reach up to SR5 million, alongside the possibility of facility closures or license cancellations for repeated or severe violations. The SFDA also urged the public to report any regulatory violations via the unified hotline (19999).
By enforcing these rules, the SFDA aims to maintain the reliability and availability of pharmaceutical products in the market, ensuring the continuous provision of critical healthcare supplies in the Kingdom.
