SFDA Penalizes 6 Facilities for Violating Drug Availability Law

The Saudi Food and Drug Authority (SFDA) declared violations against six pharmaceutical facilities that either failed to have the registered products available for the local market or didn’t report on an expected shortage or interruption in supply.
The SFDA clarified that its inspectors monitored the violating facilities during continuous monitoring and inspection visits in July. The SFDA pointed out that it imposed penalties and financial fines exceeding SAR 121,000, in accordance with the Pharmaceutical and Herbal Facilities and Products Law and its Implementing Regulation.
According to the law, manufacturers and warehouses of pharmaceutical and herbal products must have a permanent stock of all their registered preparations sufficient for a period of six months, based on consumption data and annual demand reviewed by SFDA. Unless a decision is issued by the SFDA to cancel the registered product, the law requires manufacturers and warehouses to provide compensation for any shortage in stock within a maximum of three months.
The law confirms that pharmaceutical and herbal products manufacturers and warehouses are obligated to inform SFDA in case of an expected shortage or interruption in the supply of the registered products for a period of not less than six months from the expected shortage date. They are also required to provide solutions that contribute to compensating for the shortage.
Penalties can reach up to 5 million Saudi riyals, in addition to closing the facility or canceling the license.
The SFDA calls on consumers to report violating facilities by calling the unified number 19999.