SAUDI ARABIA

SFDA detects 15 facilities for not providing pharmaceutical products to local market during July

August 12, 2023
The Saudi Food and Drug Authority (SFDA) has detected 15 facilities for not committing to provide pharmaceutical products to Local market during July.
The Saudi Food and Drug Authority (SFDA) has detected 15 facilities for not committing to provide pharmaceutical products to Local market during July.

Saudi Gazette report

RIYADH — The Saudi Food and Drug Authority (SFDA) has detected 15 facilities for not committing to provide pharmaceutical products to Local market during July.

The violating establishments also did not directly report the movement of the drug in the electronic tracking system, and did not inform SFDA about an expected shortage or interruption in the supply of the company's registered preparations.

SFDA's team monitored 3 establishments for their non-compliance in providing their registered pharmaceutical products to the market, as well as 9 pharmacies that failed to report directly (instantly) to the movement of the drug in the electronic tracking system approved by SFDA.

The team also monitored 3 establishments for their non-compliance on reporting the event of an expected shortage or interruption in the supply of registered preparations.

SFDA has imposed penalties against the violating establishments as stipulated in the Law of Pharmaceutical and Herbal Establishments and its Executive Regulations, which amounted to about SR383,600.

It is noteworthy that the Law of Pharmaceutical and Herbal Establishments obliges the factories and warehouses trading in pharmaceutical and herbal preparations to have a permanent stock sufficient for 6 months of all their registered preparations.

These establishments are also required to inform SFDA if there is an expected shortage or interruption in the supply of the company's registered preparations for a period of no less than 6 months from the expected time of the supply interruption or the impact of the stock.

They are also obligated to provide solutions that contribute to compensate for the shortage.

According to the Law of Pharmaceutical and Herbal Establishments, the penalties could reach SR5 million, in addition to temporarily closing the pharmacy for a period not exceeding 180 days, and/or revoking the license.


August 12, 2023
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