Saudi Food and Drug Authority (SFDA) penalized 45 facilities during December 2022, due to lack of commitment to provide the registered pharmaceutical products to the local market, inform instantly to the movement of the drug in the electronic tracking system, and report on expected shortage or interruption in the supply of pharmaceutical products that have been registered with the Authority.

As a part of its efforts to provide the local market with sufficient quantities of drug and ensure the compliance of stakeholders in the drug supply chain with the tasks and responsibilities assigned to them, SFDA clarified that its inspectors detected 20 facilities did not commit to provide the registered pharmaceutical products to the local market, 16 facilities failed to report on shortage or interruption expected in supplying the registered products within a period of not less than six months prior to the expected date of the shortage or interruption, and 9 facilities did not commit to report directly (instantly) to the movement of the drug in the electronic tracking system approved by the Authority.

SFDA indicated that the penalties came in accordance with the Pharmaceutical and Herbal Establishments and Substances Law and its Implementing Regulations.

The Pharmaceutical and Herbal Establishments and Substances Law obliges the plants and warehouses of the pharmaceutical and herbal products to have permanent stock sufficient for six months of all their registered products. They must also report to the Authority in case of expecting shortage or interruption in supplying the company’s registered products within a period of not less than six months prior to the expected date of shortage or interruption, and provide the solutions that contribute to compensating for the shortage or interruption.