SFDA Imposes Over SAR600,000 in Penalties on 24 Pharmaceutical Establishments for Non-Compliance

The Saudi Food and Drug Authority (SFDA) has identified 24 violations among pharmaceutical establishments for failing to provide their registered products in the local market. These violations include not promptly reporting to the SFDA’s Drug Track and Trace System (RSD), failing to notify the SFDA of anticipated shortages or supply interruptions, and not maintaining adequate stock of their products.
In August 2024, the SFDA reported that its inspectors monitored a total of 24establishments: five for failing to report directly to the RSD, nine for not providing their registered products, nine for not reporting expected shortages or supply interruptions, and one that failed to maintain sufficient stock of all its registered products for at least six months.
The SFDA stated that it imposed penalties on the violating establishments as outlined in "The Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and Their Products Guideline," totaling SAR678,400.
According to these guidelines, pharmaceutical and herbal manufacturers and warehouses are required to maintain sufficient stock for six months of all their registered products, based on annual consumption and need data reviewed by the SFDA. Any stock shortages must be addressed within a maximum of three months, unless the SFDA issues a decision to cancel the product registrations.
Pharmaceutical and herbal manufacturers, along with their representatives, must notify the SFDA of any anticipated shortages or interruptions in the supply of registered products for a duration of at least six months from the expected time of the disruption. They are also required to provide solutions to help address the shortage.
This aligns with the SFDA’s commitment to ensuring that pharmaceutical establishments adhere to its regulations, fulfilling its role in guaranteeing the availability of medicine for citizens and residents across the Kingdom of Saudi Arabia.
The SFDA confirmed that the penalties outlined in "The Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and Their Products Guideline" can reach up to SAR5 million, in addition to the potential closure of the facility or cancellation of its license. The SFDA encourages reporting any violations by contacting the unified number (19999).