The Saudi Food and Drug Authority (SFDA) slapped fines amounting to a total of SR1,433,300 on 34 pharmaceutical establishments for committing various violations during the last month of October. The violations included non-compliance by some pharmaceutical establishments to provide the drug in the local market. Some of them failed to report the movement of the drug in the ‘Rasd’ system for electronic tracking, as part of the authority’s efforts to ensure the availability of the drug in sufficient quantities in the local market and to ensure that all stakeholders in the drug supply chain adhere to the tasks and responsibilities assigned to them.
The authority said that its inspectors monitored that 24 establishments failed to report directly the movement of the drug in the electronic tracking system approved by SFDA, while another six establishments failed to provide registered preparations. It noted that the remaining four establishments did not commit to informing the authority of a shortage or interruption in the supply of the firm’s registered preparations for a period of no less than six months from the expected time of the interruption of supply or the impact of the stock while providing solutions that contribute to compensating the shortage.
The Pharmaceutical and Herbal Preparations and Establishments Regulations oblige the factories and warehouses trading in pharmaceutical and herbal preparations to have a permanent stock sufficient for six months of all their registered preparations, and these establishments must inform SFDA in the event of an expected shortage or interruption in the supply of the company’s registered preparations for a period of time not less than six months from the expected time of supply interruption or stock impact, with providing solutions that contribute to compensating for the shortage.
The authority monitors the stock of pharmaceutical and herbal preparations registered with it in factories and warehouses for trading in all regions of the Kingdom, and the adequacy of these preparations for the local market through the electronic tracking system ‘Rasd.’