RIYADH: The Saudi Food and Drug Authority has imposed fines totaling SR678,400 ($180,000) on 24 pharmaceutical firms over failures to provide registered products in the local market.
Violations cited by the SFDA included failure to report to the authority’s drug track and trace system, failure to notify the authority of likely shortages or supply interruptions, and failure to maintain adequate stocks of products, the Saudi Press Agency reported.
The SFDA said that it imposed penalties on the 24 firms as outlined in its product guidelines to pharmaceutical, and herbal and health product manufacturers.
According to the guidelines, pharmaceutical and herbal manufacturers, as well as warehouses, are required to maintain sufficient stocks of all registered products for six months, based on annual data reviewed by the SFDA.
Any stock shortages must be addressed within three months, unless the authority 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 at least six months from the expected time of the disruption.
Firms 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 guaranteeing the availability of medicine across the Kingdom.
Penalties can reach up to SR5 million, in addition to the potential closure of the facility or cancelation of its license.
The SFDA said violations can be reported by contacting the unified number 19999.
